JNJ-64264681 + JNJ-67856633 for Chronic Lymphocytic Leukemia

Recruiting at 37 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Must not be taking: BTK inhibitors, MALT inhibitors

Disqualifiers: CNS involvement, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Variable (up to 2 years and 2 months)

75 Participants Needed

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.

Research Team

Janssen Research & Development, LLC Clinical Trials

Principal Investigator

Janssen Research & Development, LLC

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive JNJ-64264681 and JNJ-67856633 in 21-day cycles until disease progression, intolerable toxicity, or withdrawal

Variable (up to 2 years and 2 months)

Regular visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years and 9 months

Periodic visits

Treatment Details

Interventions

• JNJ-64264681
• JNJ-67856633

Trial Overview 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).

Participant Groups

Group I: Part B: Cohort Expansion: JNJ-64264681 and JNJ-67856633 Experimental Treatment 2 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-67856633 Experimental Treatment 2 Interventions

Participants will receive JNJ-64264681 and JNJ-67856633 will be administered together until disease progression, intolerable toxicity, withdrawal of consent, or the investigator.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires