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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/NCT06139406
Registration number
NCT06139406
Ethics application status
Date submitted
15/11/2023
Date registered
18/11/2023
Date last updated
23/05/2024
Titles & IDs
Public title
A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin Lymphoid (NHLs) Cancer
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Scientific title
A Phase 1, First-in-human Study of JNJ-87801493 in Combination With CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoid Malignancies (NHLs)
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Secondary ID [1]
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2023-505165-93-00
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Secondary ID [2]
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87801493LYM1001
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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:
Lymphoma, Non-Hodgkin
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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 - JNJ-87801493
Treatment: Drugs - JNJ-80948543
Treatment: Drugs - JNJ-75348780
Experimental: Part 1: Dose escalation - Participants will receive one cycle of TCE monotherapy (step up to target dose) with either JNJ-80948543 or JNJ-75348780 followed by initiation of combination therapy with JNJ-87801493 one week later.
Experimental: Part 2:Dose expansion - Participants with specific B-cell NHL histologies will receive recommended phase 2 regimen (RP2R) of JNJ-87801493 with TCE as determined in Part 1.
Treatment: Drugs: JNJ-87801493
JNJ-87801493 will be administered subcutaneously.
Treatment: Drugs: JNJ-80948543
JNJ-80948543 will be administered subcutaneously.
Treatment: Drugs: JNJ-75348780
JNJ-75348780 will be administered subcutaneously.
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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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Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)
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Assessment method [1]
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Number of participants with DLTs will be reported. The DLTs are drug-related toxicities and are defined as any of the following: fatal toxicity, high grade non-hematologic toxicity, or hematologic toxicity
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Timepoint [1]
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Up to 2 years 7 months
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Primary outcome [2]
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Part 1 and 2: Percentage of Participants with Adverse Events (AEs) by Severity
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Assessment method [2]
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An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity for AEs will be specified as per: NCI-CTCAE grades which are Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (potentially life-threatening) and; American Society for Transplantation and Cellular Therapy (ASTCT) guidelines which is Grade 5 (death related to adverse event) Cytokine release syndrome (CRS) and associated neurologic toxicity events (immune effector cell-associated neurotoxicity syndrome events [ICANS]).
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Timepoint [2]
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Up to 2 years 7 months
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Secondary outcome [1]
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Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780
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Assessment method [1]
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Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
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Timepoint [1]
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Up to 2 years 7 months
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Secondary outcome [2]
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Area Under the Curve (AUCtau) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
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Assessment method [2]
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AUC tau is defined as area under the serum concentration-time curve during a dosing interval (tau).Area under the serum concentration curve (AUCtau) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
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Timepoint [2]
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Up to 2 years 7 months
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Secondary outcome [3]
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Maximum Serum Concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
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Assessment method [3]
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Maximum observed serum concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
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Timepoint [3]
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Up to 2 years 7 months
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Secondary outcome [4]
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Minimum Serum Concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
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Assessment method [4]
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Minimum observed serum concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
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Timepoint [4]
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Up to 2 years 7 months
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Secondary outcome [5]
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Area Under the Curve (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
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Assessment method [5]
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Area under the curve from time zero to t (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
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Timepoint [5]
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Up to 2 years 7 months
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Secondary outcome [6]
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Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
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Assessment method [6]
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Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
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Timepoint [6]
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Up to 2 years 7 months
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Secondary outcome [7]
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Time to Reach Cmax (Tmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
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Assessment method [7]
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Tmax is the time to reach maximum observed serum concentartion for JNJ-87801493, JNJ-80948543 and JNJ-75348780.
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Timepoint [7]
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Up to 2 years 7 months
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Secondary outcome [8]
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Apparent Total Body Clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
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Assessment method [8]
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Apparent total body clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
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Timepoint [8]
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Up to 2 years 7 months
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Secondary outcome [9]
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Apparent Volume of Distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
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Assessment method [9]
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Apparent volume of distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
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Timepoint [9]
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Up to 2 years 7 months
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Secondary outcome [10]
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Number of Participants with Presence of Anti-JNJ-87801493, Anti-JNJ- 80948543 and Anti-JNJ-75348780 Antibodies
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Assessment method [10]
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Number of participants with presence of antibodies binding to JNJ-87801493 or each combination partner (JNJ- 80948543 and JNJ-75348780).
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Timepoint [10]
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Up to 2 years 7 months
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Secondary outcome [11]
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Overall Response as Assessed by the Investigator
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Assessment method [11]
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Overall response is defined as a best response of partial response (PR) or better.
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Timepoint [11]
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Up to 2 years 7 months
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Secondary outcome [12]
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Complete Response (CR) as Assessed by the Investigator
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Assessment method [12]
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Complete response (CR) is defined as a best response of CR.
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Timepoint [12]
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Up to 2 years 7 months
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Secondary outcome [13]
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Very Good Partial Response (VGPR) or better for Waldenström Macroglobulinemia (WM) Participants as Assessed by the Investigator
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Assessment method [13]
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Very good partial response (VGPR) is defined as a best response of VGPR or better.
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Timepoint [13]
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Up to 2 years 7 months
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Secondary outcome [14]
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Time to Response (TTR) as Assessed by the Investigator
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Assessment method [14]
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Time to response (TTR) is defined for participants who achieve a response of PR or better as the time from the first dose of any study drug to the first response of PR or better.
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Timepoint [14]
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Up to 2 years 7 months
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Secondary outcome [15]
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Duration of Response (DOR) as Assessed by the Investigator
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Assessment method [15]
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Duration of response (DOR) is defined for participants who achieved a response of PR or better as the time from the first efficacy evaluation at which the participant meet all criteria for a response of PR or better to the date of first documented evidence of progressive disease or death.
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Timepoint [15]
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Up to 2 years 7 months
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Eligibility
Key inclusion criteria
- Histologic documentation of B-cell NHL. All participants must have relapsed or
refractory disease with no other approved therapies available that would be more
appropriate in the investigator's judgment
- Part 1 participants must have evaluable or measurable disease and Part 2 participants
must have measurable disease;all as defined by the appropriate disease response
criteria
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Hematologic laboratory parameters must meet the required criterias and the values must
be without a transfusion or growth factors for at least 7 days prior to the first dose
of study drug
- Participants of childbearing potential must have a negative highly sensitive serum
pregnancy test (beta (ß)-human chorionic gonadotropin) at screening and within 72
hours of the first dose of study treatment and must agree to further serum or urine
pregnancy tests during the study.
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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
- Known active central nervous system involvement (CNS) or leptomeningeal involvement.
CNS involvement may be allowed in specific cohorts as determined by the Study
Evaluation Team (SET)
- Prior solid-organ transplantation
- Prior treatment with JNJ-80948543 and/or JNJ-75348780. In addition, history of known
allergies, hypersensitivity, or intolerance to either JNJ-80948543, JNJ-75348780, or
JNJ-87801493 or its excipients
- Chemotherapy, targeted therapy, or immunotherapy within 14 days before the first dose
of study treatment. For investigational agents where the half-life is known, there
should be a treatment-free window of at least 2 weeks or 5 half-lives. For checkpoint
blockade therapy (example, anti-programmed cell death protein-1 [anti-PD-1]), a
washout period of up to 6 weeks may be considered
- Malignancy diagnosis other than the disease under study within 1 year prior to
screening. Exceptions are squamous and basal cell carcinoma of the skin, carcinoma in
situ of the cervix and any malignancy that is considered cured or has minimal risk of
recurrence within 1 year of first dose of the study drugs in the opinion of both the
investigator and sponsor's medical monitor
- Autoimmune or inflammatory disease requiring systemic corticosteroids or other
immunosuppressive agents within 1 year prior to first dose of study treatment
- Evidence of active viral, bacterial, or uncontrolled systemic fungal infection
requiring systemic treatment within 7 days before the first dose of study treatment
- Abnormal cardiac function
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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
6/12/2023
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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
8/07/2026
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Actual
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Sample size
Target
70
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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The Alfred Hospital - Melbourne
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Recruitment hospital [2]
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Linear Clinical Research Ltd - Nedlands
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Recruitment hospital [3]
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Scientia Clinical Research - Randwick
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment postcode(s) [3]
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2031 - Randwick
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Recruitment outside Australia
Country [1]
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Denmark
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State/province [1]
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Copenhagen
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Country [2]
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Denmark
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State/province [2]
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Odense
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Country [3]
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Israel
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State/province [3]
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Jerusalem
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Country [4]
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Israel
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State/province [4]
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Tel Aviv
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Country [5]
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Spain
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State/province [5]
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Barcelona
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Country [6]
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Spain
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State/province [6]
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Madrid
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Country [7]
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Spain
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State/province [7]
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Pamplona
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Country [8]
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Spain
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State/province [8]
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Salamanca
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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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 purpose of this study is to characterize safety and to determine the recommended phase 2
regimen (RP2R) for JNJ-87801493 in combination with T-cell engagers (TCEs) [Part A: Dose
Escalation] and to further assess the safety of JNJ-87801493 at the RP2R in combination with
TCEs [Part B: Dose Expansion].
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06139406
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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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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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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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Study Contact
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Address
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Country
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Phone
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844-434-4210
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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/NCT06139406
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