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Monoclonal Antibodies

JNJ-64264681 + JNJ-67856633 for Chronic Lymphocytic 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
Participants with B cell non-Hodgkin lymphoma (NHL) must have tumor tissue available at baseline as described in the protocol. This is not required for participants with chronic lymphocytic leukemia (CLL)
Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
Must not have
Known (active) central nervous system (CNS) involvement
Toxicities from previous anti-cancer therapies that have not resolved to baseline levels, or to Grade less than (<) 2 (except for alopecia [>=Grade 2], vitiligo [Grade 2] and peripheral neuropathy [Grade 1])
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years and 9 months
Awards & highlights

Summary

This trial is testing two drugs to see what the best dose is to treat B cell NHL and CLL, and also to see how safe they are in different populations.

Who is the study for?
This trial is for adults with certain types of blood cancers, like Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia. They should be relatively healthy (ECOG grade 0 or 1), have a specific heart rhythm measurement within normal limits, and women must use effective contraception. People who've had previous treatments with the study drugs or certain other cancer therapies can't join.Check my eligibility
What is being tested?
The trial is testing two drugs, JNJ-64264681 and JNJ-67856633, to find safe doses when used together in patients with B cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. It has two parts: dose finding (Part A) and checking safety across different patient groups (Part B).See study design
What are the potential side effects?
Potential side effects aren't specified here but typically could include reactions at the infusion site, fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems, liver function changes, allergic reactions or other organ-specific issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have B cell non-Hodgkin lymphoma and my tumor tissue is available for testing.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to my brain or spinal cord.
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Side effects from my past cancer treatments have mostly gone away or are mild.
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I am allergic to JNJ-64264681, JNJ 67856633, or their ingredients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years and 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years and 9 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 A and Part B: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Part A: Number of Participants with Dose-limiting Toxicity (DLT)
Secondary outcome measures
Bruton's Tyrosine Kinase (BTK) Occupancy in Peripheral Blood Mononuclear Cell (PBMCs)
Duration of Response
Overall Response Rate (ORR)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: Cohort Expansion: JNJ-64264681 and JNJ-67856633Experimental Treatment2 Interventions
Participants will receive JNJ-64264681 and JNJ-67856633 at the recommended Phase 2 dose (RP2D) determined in Part 1.
Group II: Part A: Dose escalation: JNJ-64264681 and JNJ-67856633Experimental Treatment2 Interventions
Participants will receive JNJ-64264681 and JNJ-67856633 will be administered together until disease progression, intolerable toxicity, withdrawal of consent, or the investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-64264681
2018
Completed Phase 1
~110

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
980 Previous Clinical Trials
6,384,218 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialsStudy DirectorJanssen Research & Development, LLC
11 Previous Clinical Trials
201,922 Total Patients Enrolled

Media Library

JNJ-64264681 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04657224 — Phase 1
Chronic Lymphocytic Leukemia Research Study Groups: Part A: Dose escalation: JNJ-64264681 and JNJ-67856633, Part B: Cohort Expansion: JNJ-64264681 and JNJ-67856633
Chronic Lymphocytic Leukemia Clinical Trial 2023: JNJ-64264681 Highlights & Side Effects. Trial Name: NCT04657224 — Phase 1
JNJ-64264681 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04657224 — Phase 1
~16 spots leftby Jul 2025