JNJ-67856633 for Lymphoma and Leukemia

Recruiting in Palo Alto (17 mi)

+61 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 tests JNJ-67856633, an oral drug, in patients with certain blood cancers that have returned or resisted treatment. The drug works by blocking a protein that helps cancer cells grow. The study aims to find the safest dose and see if the drug is effective.

Eligibility Criteria

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.

Inclusion Criteria

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.

Women of childbearing potential must have a negative highly sensitive serum (Beta human chorionic gonadotropin) at screening and prior to the first dose of study drug, and until 30 days after the last dose

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Exclusion Criteria

I have been treated with a MALT1 inhibitor before.

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.

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Treatment Details

Interventions

JNJ-67856633 (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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.