JNJ-64264681 for Non-Hodgkin's Lymphoma and Leukemia

Recruiting in Palo Alto (17 mi)

+15 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 a new drug called JNJ-64264681 to find the best dose and ensure it is safe. It focuses on patients with specific blood cancers, namely B cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. The drug aims to attack and kill the cancer cells in these patients.

Eligibility Criteria

This trial is for adults with certain types of blood cancers, like Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia. They should be relatively healthy (ECOG grade 0 or 1), able to follow the study rules, and have normal heart rhythm readings. Women must test negative for pregnancy and agree not to donate eggs during the study.

Inclusion Criteria

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

Participants must have cardiac parameters within the following range: corrected QT interval (QTcF) <= 480 milliseconds based on the average of triplicate assessments performed as close as possible in succession (the full set of triplicates should be completed in less than 10 minutes)

Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of at least 30 days after the last study drug administration

+2 more

Exclusion Criteria

I haven't taken any experimental drugs or vaccines within the last 2 weeks or five half-lives before starting the study drug.

Participant has received prior solid organ transplantation

My cancer has spread to my brain or spinal cord.

+2 more

Participant Groups

The trial is testing JNJ-64264681's safety and optimal dose in two parts: first finding the best dose, then checking its safety at that dose in patients with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

1Treatment groups

Experimental Treatment

Group I: JNJ-64264681: Dose Escalation and ExpansionExperimental Treatment1 Intervention

Participants will receive oral administration of JNJ-64264681 capsule at a dose assigned by the sponsor Study Evaluation Team (SET), based on the available safety, pharmacokinetics, and pharmacodynamics data in dose escalation treatment group (Part 1); and recommended Phase 2 dose (RP2D) determined in Part 1 in cohort expansion treatment group (Part 2).