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Monoclonal Antibodies

JNJ-67856633 for Lymphoma and Leukemia

Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
Be older than 18 years old
Must not have
Prior treatment with a mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1) inhibitor
Either of the following: a) Received an autologous stem cell transplant <=3 months before the first dose of study drug. b) Prior treatment with allogenic stem cell transplant <=6 months before the first dose of study drug, has evidence of graft versus host disease, or requires immunosuppressant therapy for graft versus host disease within the last 4 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years and 11 months
Awards & highlights

Summary

This trial is studying a drug to see what dose is safe and effective for people with relapsed or refractory B-cell non-Hodgkin lymphoma or chronic lymphocytic leukemia.

Who is the study for?
This trial is for adults with certain types of blood cancer, like Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia that has come back or didn't respond to treatment. They should have a heart rhythm within normal limits and be able to do most daily activities on their own. Women must test negative for pregnancy and both men and women need to use reliable birth control.Check my eligibility
What is being tested?
The study is testing the safety and best dose of a new drug called JNJ-67856633 in patients whose blood cancers have returned after treatment or haven’t responded at all. The goal is to find the highest dose patients can take without too many side effects.See study design
What are the potential side effects?
Specific side effects of JNJ-67856633 are not listed, but common ones for cancer treatments include nausea, fatigue, risk of infection, allergic reactions, and changes in blood counts. Side effects depend on how much medicine you get.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with a MALT1 inhibitor before.
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I had a stem cell transplant recently and may have graft versus host disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years and 11 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years and 11 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Part 1: Dose-Limiting Toxicity (DLT)
Secondary outcome measures
JNJ-67856633 Plasma Concentrations
Part 1 and Part 2: Complete Response Rate
Part 1 and Part 2: Duration of Response (DoR)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2 (Cohort Expansion): JNJ-67856633Experimental Treatment1 Intervention
Participants will receive JNJ-67856633 at the recommended Phase 2 dose (RP2D) determined in Part 1.
Group II: Part 1 (Dose Escalation): JNJ-67856633Experimental Treatment1 Intervention
Participants will receive JNJ-67856633 until disease progression, intolerable toxicity, withdrawal of consent, or the investigator or sponsor decision. Subsequent dose levels will be assigned by the sponsor using an adaptive dose escalation strategy based on all available safety, pharmacokinetic (PK), and biomarker data.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Hodgkin's Lymphoma (NHL) include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect healthy cells. Immunotherapy, such as monoclonal antibodies (e.g., rituximab), targets specific proteins on the surface of cancer cells, marking them for destruction by the immune system. Targeted therapies, like the investigational drug JNJ-67856633, focus on specific molecular targets involved in the growth and survival of cancer cells. For instance, Bruton tyrosine kinase (BTK) inhibitors block signals that promote B-cell malignancies. These targeted approaches are crucial for NHL patients as they offer more precise treatment options with potentially fewer side effects compared to traditional chemotherapy, improving overall outcomes and quality of life.

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Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
980 Previous Clinical Trials
6,384,067 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
749 Previous Clinical Trials
3,960,721 Total Patients Enrolled

Media Library

JNJ-67856633 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03900598 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: Part 1 (Dose Escalation): JNJ-67856633, Part 2 (Cohort Expansion): JNJ-67856633
Non-Hodgkin's Lymphoma Clinical Trial 2023: JNJ-67856633 Highlights & Side Effects. Trial Name: NCT03900598 — Phase 1
JNJ-67856633 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03900598 — Phase 1
~13 spots leftby Dec 2024