JNJ-64264681 + JNJ-67856633 for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

+37 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

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

Cardiac parameters within the following range: corrected QT interval (QTcF) <= 480 milliseconds

I am fully active or restricted in physically strenuous activity but can do light work.

+1 more

Exclusion Criteria

Received prior solid organ transplantation

My cancer has spread to my brain or spinal cord.

I have previously been treated with JNJ 64264681 or JNJ-67856633, or stopped a BTK/MALT inhibitor without bad side effects.

+2 more

Participant Groups

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).

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.