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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years and 11 months
Awards & highlights
Study 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 belowSelect...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years and 11 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years and 11 months
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 moreTrial 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.
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Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
978 Previous Clinical Trials
6,384,843 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
747 Previous Clinical Trials
3,960,421 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with a MALT1 inhibitor before.I will use a condom during sex, and my partner may use birth control too.I am using a highly effective birth control method plus a condom.I haven't had cancer, other than my current type, in the last year.My brain or spinal cord cancer has been evaluated by the study team.I had a stem cell transplant recently and may have graft versus host disease.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 (Dose Escalation): JNJ-67856633
- Group 2: Part 2 (Cohort Expansion): JNJ-67856633
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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