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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/NCT04984356
Registration number
NCT04984356
Ethics application status
Date submitted
29/07/2021
Date registered
30/07/2021
Date last updated
24/11/2023
Titles & IDs
Public title
A Phase 1/2 Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL
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Scientific title
A Phase 1/2 Dose-Escalation and Dose-Expansion Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL)
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Secondary ID [1]
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WU-CART-007 1001
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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:
T-cell Acute Lymphoblastic Leukemia
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Lymphoblastic 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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Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - WU-CART-007
Experimental: WU-CART-007 - A CD7-directed chimeric antigen receptor (CAR) T-cell product.
A single IV infusion of WU-CART-007 Cells on Day 1 after Lymphodepletion(LD) Therapy.
Other interventions: WU-CART-007
A single IV infusion of WU-CART-007 Cells on Day 1
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Intervention code [1]
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Other interventions
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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 Adverse Events of WU-CART-007 as assessed by CTCAE v5
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Assessment method [1]
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Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of consent until end of study visit
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Timepoint [1]
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24 months
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Primary outcome [2]
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Maximum Tolerated Dose (MTD)
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Assessment method [2]
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Maximum tolerated or administered dose of WU-CART-007
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Timepoint [2]
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up to 28 days from first dose
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Primary outcome [3]
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Composite Complete Response Rate
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Assessment method [3]
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Defined as proportion of patients that achieve a complete remission (CR) + complete remission with incomplete hematologic recover ( CRi) + CR with partial hematologic recovery (CRh)
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Timepoint [3]
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24 months
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Secondary outcome [1]
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Overall Survival
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Assessment method [1]
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Time from study drug administration (Day 1) to death on study
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Timepoint [1]
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24 months
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Secondary outcome [2]
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Objective Response Rate
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Assessment method [2]
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ORR is defined as proportion of patients that achieve complete remission (CR) + complete remission with incomplete hematologic recover ( CRi) + CR with partial hematologic recovery (CRh), morphologic leukemia free state (MLFS, and partial response (PR) in patients with EMD only
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Timepoint [2]
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24 months
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Secondary outcome [3]
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Duration of Response
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Assessment method [3]
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Time of response to the time of disease relapse, progression or death due to any cause. whichever occurs first
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Timepoint [3]
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24 months
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Secondary outcome [4]
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Hematopoietic Stem Cell Transplant (HSCT) rate
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Assessment method [4]
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Rate of successful transition to HSCT through study treatment
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Timepoint [4]
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24 months
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Eligibility
Key inclusion criteria
Key Inclusion/
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Minimum age
12
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
Specific inclusion criteria apply to each disease subtype. In general, all patients will
have:
- Evidence of relapsed or refractory T-ALL or T-LBL, as defined by World Health
Organization (WHO) classification with bone marrow with = 5% lymphoblasts by
morphologic assessment or evidence of extramedullary disease at screening.
- Relapsed or refractory disease defined as at least one of the following criteria:
1. Primary refractory: failure to achieve CR after induction chemotherapy, per
investigator.
2. Early Relapse: relapsed disease within 12 months of initial diagnosis.
3. Late Relapse (relapsed refractory disease): relapsed disease after 12 months of
initial diagnosis AND failure of re-induction therapy after disease recurrence.
4. Relapsed or refractory disease after allogeneic transplant, and meet the
following criteria:
i. There must be histological confirmation of relapse after HSCT of T-ALL or T-LBL.
ii. Undergone allogeneic HSCT > 90 days prior to enrollment from a match related or
unrelated donor, cord blood donor, haplo-identical, or autologous stem cells.
iii. Off all immunosuppressive medications for a minimum of 2 weeks with the exception of
physiologic doses of corticosteroids.
iv. No prior history of Grade 2 or greater (per Cairo-Bishop) veno-occlusive disease
(VOD)/sinusoidal obstruction syndrome, or active graft versus host disease (GvHD) (see
exclusion criteria below for exceptions).
- Adequate renal, hepatic, respiratory, and cardiovascular function, as defined in the
body of the protocol.
- Life expectancy >12 weeks
- Age: Lower age limit of 12 years. Adolescent ages 12-17 will be eligible for
enrollment beginning at Dose Level 3 of the Dose Escalation phase, after review of
safety, efficacy and cellular PK data and after consultation with the appropriate
regulatory agencies.
- ECOG/Karnofsky performance status 0 or 1 at screening (Adults age >16) or Lansky
Performance Status 60 and above (adolescents = 16),
- Ability to understand the nature of this study, comply with protocol requirements, and
give written informed consent. For minors, legal guardian willingness to give written
informed consent with patient assent, where appropriate.
- Willing to participate in WUC-007-02 for long-term follow up.
Patients will be excluded from study entry if:
- They have received previous treatment with any prior anti-CD7 therapy.
- Have not recovered from the effects of previous therapy.
- Wash-out period of at least 5 half-lives from the last dose of any investigational
therapy prior to screening period and all related toxicities resolved to Grade 1 or
baseline.
- Have active or latent hepatitis B or active hepatitis C, any uncontrolled infection,
or untreated HIV positive.
- Have any serious active infection at the time of treatment, or another serious
underlying medical condition that would impair the ability of the patient to receive
protocol treatment.
- Have Grade 2 to 4 acute or extensive chronic GvHD requiring systemic immunosuppression
(steroids). Grade 1 GvHD not requiring immunosuppression is acceptable and grade 2
skin GvHD if treated with topical therapy only is acceptable.
- Have psychological, familial, sociological, or geographical conditions that do not
permit compliance with the protocol.
- Pregnant or nursing (lactating) women
- Require prohibited medications or treatments, eg, steroids, or anti-neoplastic agents
- Treated with anti-T cell monoclonal antibodies
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not 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
14/01/2022
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
1/08/2026
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Actual
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Sample size
Target
44
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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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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Florida
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United States of America
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Missouri
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Wisconsin
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France
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Paris
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Country [8]
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Netherlands
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State/province [8]
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Rotterdam
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Country [9]
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Netherlands
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State/province [9]
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Utrecht
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Wugen, 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
The main purpose of this study is to evaluate the safety, recommended dose, and preliminary
anti-tumor activity of WU-CART-007 in patients with relapsed or refractory (R/R) T-cell acute
lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04984356
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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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Jan Davidson, MD
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Address
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Wugen, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04984356
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