← Back to Search

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

No Placebo-Only Group

Summary

This trial is testing two new drugs, JNJ-64264681 and JNJ-67856633, in patients with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). The drugs work by blocking proteins that help cancer cells grow and survive.

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.

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).

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

Select...

I have B cell non-Hodgkin lymphoma and my tumor tissue is available for testing.

Select...

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:

Select...

My cancer has spread to my brain or spinal cord.

Select...

Side effects from my past cancer treatments have mostly gone away or are mild.

Select...

I am allergic to JNJ-64264681, JNJ 67856633, or their ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years and 9 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Bruton's Tyrosine Kinase (BTK) Occupancy in Peripheral Blood Mononuclear Cell (PBMCs)

Duration of Response

Overall Response Rate (ORR)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met