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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06248086
Registration number
NCT06248086
Ethics application status
Date submitted
31/01/2024
Date registered
8/02/2024
Date last updated
20/05/2024
Titles & IDs
Public title
A Study to Find a Suitable Dose of ASP2802 in People With CD20-positive B-cell Lymphomas
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Scientific title
A First-in-Human, Phase 1 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of a Single-Induction Dose of convertibleCARTM-T Cells Armed With MicAbodyTM Protein (ASP2802) Followed by Maintenance Booster Doses of the MicAbody Protein in Patients With CD20-Positive Relapsed or Refractory B-Cell Lymphomas
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Secondary ID [1]
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2802-CL-0101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
B-cell Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ASP2802
Treatment: Drugs - MA-20
Experimental: Group A: ASP2802 Low Dose followed by MA-20 - Participants will receive a low dose of ASP2802 on Day 0 of cycle 1. Each participant will then receive up to 2 doses of MA-20 booster in each 28-day cycle.
Experimental: Group B: ASP2802 Intermediate Dose followed by MA-20 - Participants will receive an intermediate dose of ASP2802 on Day 0 of cycle 1. Each participant will then receive up to 2 doses of MA-20 booster in each 28-day cycle, with dose level(s) selected from Group A.
Experimental: Group C: ASP2802 High Dose followed by MA-20 - Participants will receive a higher dose of ASP2802 on Day 0 of cycle 1. Each participant will then receive up to 2 doses of MA-20 booster in each 28-day cycle, with dose level(s) selected from Group B.
Treatment: Drugs: ASP2802
Intravenous (IV) infusion
Treatment: Drugs: MA-20
IV infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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A DLT is defined as any event meeting the DLT criteria occurring within 28 days after ASP2802 (MACT) infusion and/or 28 days after the first dose of each administered dose of MA-20 during the dose escalation phase not attributable to a cause other than investigational product (IP).
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Timepoint [1]
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Up to 10 months
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Primary outcome [2]
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Number of participants with Adverse Events (AEs)
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Assessment method [2]
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An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study IP, whether or not considered related to the study IP and other study treatments.
Note: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of study IP and other study treatments. This includes events related to the (study) procedures.
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Timepoint [2]
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Up to 26 months
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Primary outcome [3]
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Number of participants with Serious Adverse Events (SAEs)
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Assessment method [3]
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A Serious Adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other medically important event.
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Timepoint [3]
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Up to 26 months
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Primary outcome [4]
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Number of participants with laboratory value abnormalities and/or AEs
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Assessment method [4]
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Number of participants with potentially clinically significant laboratory values.
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Timepoint [4]
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Up to 26 months
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Primary outcome [5]
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Number of Participants with vital sign abnormalities and/or AEs
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Assessment method [5]
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Number of participants with potentially clinically significant vital sign values.
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Timepoint [5]
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Up to 26 months
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Primary outcome [6]
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Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs
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Assessment method [6]
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Number of participants with potentially clinically significant ECG values.
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Timepoint [6]
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Up to 26 months
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Primary outcome [7]
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Number of Participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status scores
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Assessment method [7]
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The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
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Timepoint [7]
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Up to 26 months
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Secondary outcome [1]
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Pharmacokinetics (PK) of ASP2802 in blood: Maximum Concentration (Cmax)
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Assessment method [1]
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Cmax will be recorded from the PK blood samples collected.
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Timepoint [1]
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Up to 26 months
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Secondary outcome [2]
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PK of ASP2802 in blood: Time to maximum concentration (tmax)
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Assessment method [2]
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tmax will be recorded from the PK blood samples collected.
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Timepoint [2]
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Up to 26 months
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Secondary outcome [3]
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PK of ASP2802 in blood: Area under the concentration-time curve (AUC)0-28d
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Assessment method [3]
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AUC0-28d will be recorded from the PK blood samples collected.
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Timepoint [3]
0
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Up to 26 months
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Secondary outcome [4]
0
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PK of ASP2802 in blood: concentration
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Assessment method [4]
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Concentration will be recorded from the PK plasma samples collected.
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Timepoint [4]
0
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Up to 26 months
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Secondary outcome [5]
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PK of MA-20 in serum: Cmax
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Assessment method [5]
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Cmax will be recorded from the PK serum samples collected.
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Timepoint [5]
0
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Up to 26 months
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Secondary outcome [6]
0
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PK of MA-20 in serum: tmax
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Assessment method [6]
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tmax will be recorded from the PK serum samples collected.
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Timepoint [6]
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Up to 26 months
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Secondary outcome [7]
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PK of MA-20 in serum: Trough concentration (Ctrough)
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Assessment method [7]
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Ctrough will be recorded from the PK serum samples collected.
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Timepoint [7]
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Up to 26 months
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Secondary outcome [8]
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PK of MA-20 in serum: AUC0-14d
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Assessment method [8]
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AUC0-14d will be recorded from the PK serum samples collected.
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Timepoint [8]
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Up to 26 months
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Secondary outcome [9]
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PK of MA-20 in serum: Apparent terminal half-life (t1/2)
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Assessment method [9]
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t1/2 will be recorded from the PK serum samples collected.
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Timepoint [9]
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Up to 26 months
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Secondary outcome [10]
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PK of MA-20 in serum: Apparent terminal elimination rate constant (Kel)
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Assessment method [10]
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Kel will be recorded from the PK serum samples collected.
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Timepoint [10]
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Up to 26 months
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Secondary outcome [11]
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PK of MA-20 in serum: Clearance (CL)
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Assessment method [11]
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CL will be recorded from the PK serum samples collected.
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Timepoint [11]
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Up to 26 months
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Secondary outcome [12]
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Number of participants with positive anti-drug antibodies to MA-20
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Assessment method [12]
0
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Timepoint [12]
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Up to 26 months
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Secondary outcome [13]
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Objective Response Rate (ORR) of ASP2802 per Lugano Response Criteria
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Assessment method [13]
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ORR is defined as the proportion of participants whose best overall response is a Complete Response (CR) or Partial Response (PR).
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Timepoint [13]
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Up to 26 months
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Secondary outcome [14]
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Best Overall Response (BOR) of ASP2802 per Lugano Response Criteria
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Assessment method [14]
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BOR is defined as the proportion of participants achieving CR or PR based on the Lugano Treatment Response Criteria for NHL.
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Timepoint [14]
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Up to 26 months
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Secondary outcome [15]
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Duration of Response (DOR) of ASP2802 per Lugano Response Criteria
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Assessment method [15]
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DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented disease progression (PD) or death due to any cause, whichever occurs first.
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Timepoint [15]
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Up to 26 months
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Secondary outcome [16]
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Progression Free Survival (PFS) of ASP2802
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Assessment method [16]
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PFS is defined as time from start of treatment to progressive disease (PD) or death from any cause, whichever occurs first.
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Timepoint [16]
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Up to 26 months
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Secondary outcome [17]
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Overall Survival (OS) of ASP2802
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Assessment method [17]
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OS is defined as is defined as time from start of ASP2802 to death.
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Timepoint [17]
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Up to 88 months
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Eligibility
Key inclusion criteria
- Participant has histologically-confirmed cluster of differentiation (CD) 20-positive
B-cell lymphoma (CD20 expression should be demonstrated by local testing at the time
of relapse or progression and within 1 month of study screening) which may include the
following aggressive large cell or indolent subtypes.
- Diffuse large B-cell lymphoma (DLBCL), Not otherwise specified (NOS)
- Follicular lymphoma grade 3B
- Primary mediastinal large B-cell lymphoma
- T-cell/histiocyte-rich large B-cell lymphoma
- DLBCL associated with chronic inflammation
- Intravascular large B-cell lymphoma
- Anaplastic lymphoma kinase fusion gene (ALK)+ large B-cell lymphoma
- B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and
classical Hodgkin lymphoma
- High grade B-cell lymphoma with proto-oncogene located on chromosome 8 (MYC) and
B-cell leukemia/lymphoma 2 gene (BCL2) and/or B-cell leukemia/lymphoma 6 gene
(BCL6) rearrangements
- High-grade B-cell lymphoma, NOS
- Human herpes virus type 8 (HHV8)+ DLBCL, NOS
- Primary cutaneous DLBCL, leg type
- Transformed follicular lymphoma
- Follicular lymphoma
- Marginal zone lymphoma
- Participant has either relapsed or refractory disease defined as:
- Relapse after = 2 prior lines of therapy; or
- Refractory disease: After = 2 prior lines of therapy and did not achieve complete
response (CR)
- Participants who have undergone autologous stem cell transplant (SCT) with disease
progression or relapse following SCT will be eligible if all other eligibility
criteria are met.
- Participants with lymphoma must have evaluable or measurable disease according to the
Lugano criteria for response assessment of lymphoma. Lesions that have been previously
irradiated will be considered measurable only if progression has been documented
following completion of radiation therapy.
- At least 2 weeks or 5 half-lives, whichever is longer, must have elapsed since any
prior anticancer therapy at the time of leukapheresis, except for
inhibitory/stimulatory immune checkpoint therapy, which requires 3 half-lives.
Exceptions:
- There is no time restriction with regard to prior intrathecal chemotherapy (including
steroids) provided there is complete recovery from any acute toxic effects of such.
- Participants receiving steroid therapy at physiologic replacement doses (= 5
milligrams per day (mg/day) of prednisone or equivalent doses of other
corticosteroids) are allowed. Use of higher doses of systemic steroids must stop at
least 72 hours before leukapheresis.
- Radiation therapy must have been completed at least 2 weeks prior to leukapheresis.
- Toxicities due to prior therapy must be stable and recovered to = Grade 1 (except
for clinically non-significant toxicities, such as alopecia, nutritional support
measures, electrolyte abnormalities or those not impacting the investigator's
ability to assess treatment-emergent toxicities).
- Participant has cardiac ejection fraction (EF) = 45%, no evidence of
physiologically significant pericardial effusion as determined by an
echocardiogram or multigated acquisition scan (MUGA) and no clinically
significant ECG findings.
- Participant has no clinically significant pleural effusion.
- Participant has baseline oxygen saturation > 90% on room air at rest.
- Participant has a life expectancy of = 12 weeks.
- Participant has an ECOG performance score of 0, 1 or 2.
- Female participant is not pregnant and at least 1 of the following conditions
apply:
- Not a woman of childbearing potential (WOCBP).
- WOCBP who agrees to follow the contraceptive guidance from the time of informed
consent through at least 6 months after final study treatment administration.
- Female participant must agree not to breastfeed starting at screening and
throughout the study period and for 6 months after final study treatment
administration.
- Female participant must not donate ova starting at first dose of IP and
throughout the study period and for 6 months after final study treatment
administration.
- Male participant with female partner(s) of childbearing potential (including
breastfeeding partner) must agree to use contraception throughout the treatment
period and for 6 months after final study treatment administration.
- Male participant must not donate sperm during the treatment period and for 6
months after final study treatment administration.
- Male participant with pregnant partner(s) must agree to remain abstinent or use a
condom for the duration of the pregnancy throughout the study period and for 6
months after final study treatment administration.
- Participant agrees not to participate in another interventional study while
participating in the present study
- Participant has adequate organ function at baseline. If a participant has
received a recent blood transfusion, the laboratory tests must be obtained = 28
days after any blood transfusion.
Additional Inclusion Criteria prior to Lymphodepletion Chemotherapy:
- Participant has adequate hepatic function defined by aspartate aminotransferase (AST)
and alanine aminotransferase (ALT) = 3 × upper limit of normal (ULN); total bilirubin
= 1.5 × ULN (participants with Gilbert's syndrome may be included if their total
bilirubin is = 3.0 × ULN and direct bilirubin is = 1.5 × ULN)
- Participant has adequate renal function defined by:
- Creatinine < 1.5 × ULN, or
- An estimated creatinine clearance (CrCl) of = 60 milliliter per minute (ml/min)
as calculated by the Cockcroft-Gault equation
- Participant has adequate bone marrow function defined by absolute neutrophil count =
500/microliter (µl) and platelet count = 50 000/µl (unless inadequate bone marrow
function is thought to be related to bone marrow involvement with the
lymphoproliferative neoplasm).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participant has been diagnosed with the following conditions:
- B-lymphoblastic leukemia/lymphoma (B-ALL/LBL)
- chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
- Burkitt lymphoma
- Richter's transformation of CLL/SLL
- Epstein-Barr virus (EBV)+ DLBCL, NOS
- Mantle cell lymphoma
- Known history or suspicion of central nervous system involvement by lymphoma.
- Participant weighs < 45 kilograms (kg) at screening.
- Participant had prior allogeneic hematopoietic stem cell transplantation (HSCT).
- Participant has received any investigational therapy within 28 days or 5 half-lives,
whichever is longer, prior to screening.
- Participant has a history of non-study related malignancy other than non-melanoma skin
cancer or carcinoma in situ (e.g., cervix, bladder, breast) unless disease free for at
least 3 years.
- Participant has a history of myocardial infarction, cardiac angioplasty or stenting,
unstable angina or other clinically significant cardiac disease within 12 months of
enrollment or has cardiac atrial or cardiac ventricular lymphoma involvement.
- Participant has known abnormal lung function: forced expiratory volume (FEV) < 60%
prediction, diffusing capacity of the lung for carbon monoxide < 60% prediction, blood
oxygen saturation < 90% on room air.
- Participant has intracranial hypertension or unconsciousness, respiratory failure or
disseminated intravascular coagulation.
- Participant has leukocytosis (white blood cell [WBC] count = 25 000/µL) or rapidly
progressive disease that would compromise ability to complete study therapy.
- Participant has a history or presence of a central nervous system (CNS) disorder such
as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, seizure disorder
or autoimmune disease with CNS involvement that may impair the ability to evaluate
neurotoxicity.
- Participant has any of the following per screening serology test:
- Hepatitis A virus (HAV) antibodies immunoglobulin M (IgM)
- Positive hepatitis B surface antigen (HBsAg) or detectable hepatitis B
Deoxyribonucleic acid (DNA). Participants with negative HBsAg, positive hepatitis
B core antibody (anti-HBc) and negative anti-HBs are eligible if hepatitis B DNA
is undetectable
- hepatitis C virus (HCV) antibodies unless HCV ribonucleic acid (RNA) is
undetectable
- Participant has human immunodeficiency virus (HIV) per screening serology test.
- Participant has a positive severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) polymerase chain reaction (PCR) test at Screening.
- Participant has a primary immunodeficiency or history of systemic autoimmune disease
(e.g., Crohn's, rheumatoid arthritis, systemic lupus) resulting in end organ injury or
requiring systemic immunosuppression/disease-modifying agents within the last 2 years.
- Participant has presence of fungal, bacterial (e.g., tuberculosis), viral or other
infection that is uncontrolled or requiring IV antimicrobials for management. Simple
infections like urinary tract infections and uncomplicated bacterial pharyngitis are
permitted if responding to active treatment.
- Participant's adverse reactions (excluding alopecia or vitiligo) from prior therapy
have not improved to Grade 1 or baseline at least 14 days prior to Screening.
- Participant has received rituximab within 14 days prior to Screening.
- Participant has presence of any other concurrent medical condition or factors that
would prevent the participant from undergoing or completing protocol-specified
treatment, or makes the participant unsuitable for study participation.
- Participant had prior treatment with CD20 CAR-T cell or CD20 bi-specific therapy.
- Participant has a known or suspected hypersensitivity to ASP2802 (MACT), MA-20,
fludarabine, cyclophosphamide or any components of the formulations used.
- Participant is receiving treatment with anticoagulants.
Additional Exclusion Criteria required for Lymphodepletion Chemotherapy:
- Participant received bridging therapy within 10 days prior to start of lymphodepletion
chemotherapy (LDC).
- Participant has an active systemic infection present or onset of fever = 38°C/100.4°F,
not related to underlying disease. Participants who meet either of these on the day of
scheduled ASP2802 (MACT) infusion should have ASP2802 (MACT) administration delayed.
- Participant has a positive SARS-CoV-2 PCR test.
- Participant has an intercurrent illness or toxicity that would place the participant
at undue risk of proceeding to LDC and ASP2802 (MACT) infusion.
- Participant is receiving therapeutic doses of corticosteroids (defined as = 20 mg/day
prednisone or equivalent) within 24 hours prior to LDC. Physiologic replacement,
topical, intranasal and inhaled steroids are permitted.
- Participant has signs of pre-existing CNS disease or toxicity.
- Participant has had major surgery within 28 days prior to the start of study
treatment.
- Participants should not experience a significant worsening in clinical status compared
to initial eligibility criteria that would increase the risk of adverse events
associated with LDC or ASP2802 (MACT) infusion.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/04/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/05/2031
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Actual
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Sample size
Target
21
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Site AU61005 - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Astellas Pharma Global Development, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
CAR-T cell therapy is a type of treatment for people with certain lymphomas. T-cells are
white blood cells that help to fight infections. CAR-T cell therapy improves the body's
T-cells to help them better fight cancer cells.
ASP2802 is a type of CAR-T cell therapy given with MA-20. MA-20 is a protein that helps the
CAR-T cell therapy work inside the body.
Before ASP2802 is available as a treatment, the researchers need to understand how it is
processed by and acts upon the body. This information will help find a suitable dose for
future studies and check for potential medical problems from the treatment.
In this study, ASP2802 is being tested in humans for the first time. ASP2802 has already been
tested in the laboratory and in animals. This is the standard way new potential treatments
are developed.
People taking part in this study will be adults with CD20-positive B-cell lymphomas. CD20 is
a protein found on a type of white blood cell called a B-cell. Some people with B-cell
lymphomas have more CD20 on these cells. Their cancer will have come back after it had
disappeared with earlier therapy (relapsed) or it will have become resistant to previous
treatment (refractory).
The main aims of the study are to check the safety of ASP2802, how well it is tolerated, and
to find a suitable dose of ASP2802.
This is an open-label, adaptive study. Open-label means that people in this study and clinic
staff will know that people will receive ASP2802 treatment. Adaptive means the treatments may
change, depending on earlier results in the study.
There will be 3 groups of people in this study and 3 doses of ASP2802. Groups A, B and C will
receive ASP2802 treatment. Group A will start treatment first with a low dose of ASP2802. If
Group A tolerates the low dose of ASP2802, then Group B will receive the higher dose of
ASP2802. If Group B tolerates the higher dose of ASP2802, then Group C will receive the
highest dose of ASP2802.
There are several steps in this treatment. First, T-cells are removed from the blood by
inserting a small tube (cannula) into a vein and connecting it to a machine that separates
out the blood cells. The machine collects the T-cells and returns the rest of the blood cells
back into the bloodstream. The collected T-cells are sent to the lab to be changed into
improved T-cells (with ASP2802) to fight the cancer. This may take several weeks, so people
in the study may receive extra treatment, to keep the cancer under control during this time.
Before the improved T-cells go back in the body, people will visit the clinic so that the
study doctors can do a series of checks to make sure they are well enough to receive the
T-cells. A few days before the improved T-cells go back into the body, people in the study
will have chemotherapy for 3 days. This is to make sure the cancer is at its lowest level
before people are treated with ASP2802. Then, the improved T-cells are fed back into the
bloodstream using a drip attached to the cannula. After this, a booster of MA-20 will be
given at the set dose by infusion on Day 3 and Day 17 in a 28-day cycle. If people respond
well to treatment, they may stay on the same dose during the next cycle; if they have medical
problems from the treatment, they may get a lower dose during the next cycle. The next group
of people may receive a different dose (higher or lower) of MA-20 depending on the results
from the previous group. People in the study will continue receiving MA-20 in this way until:
they have certain medical problems from the treatment on the lowest dose of MA-20; they start
other cancer treatment; their cancer gets worse; they or the study doctor decides they should
stop treatment; they do not come back for treatment.
After treatment has finished, people in the study will visit the clinic regularly for 2 years
and continue to be monitored for up to 15 years.
Some people may be treated again with MA-20. This may happen for people who have responded to
treatment and then relapse within a year, or for people that have a partial response and have
a slow growing lymphoma.
During the study, people will visit the study hospital many times. During most visits, the
study doctors will do a medical examination, blood tests and check vital signs. Vital signs
include temperature, breathing rate, blood pressure, blood oxygen levels, and heart rate.
They will also check for medical problems. In some visits, computerized tomography (CT) scans
and electrocardiograms (ECGs) to check the heart rhythm will also be done.
People will have several hospital stays during their treatment. This may be during their
chemotherapy, then from Days -1 to 7 and Days 17 to 21 during the cycle 1 of MA-20. Day -1
means 1 day before treatment with ASP2802. During this time, people will be closely monitored
for medical problems, have EGCs and have a biopsy taken. During the extra cycles of MA-20,
there will be the option of staying overnight.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06248086
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Central Contact
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Address
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Astellas Pharma Global Development, Inc.
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Country
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0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Astellas Pharma Global Development, Inc.
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Address
0
0
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Country
0
0
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Phone
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0
800-888-7704
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06248086
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