A Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in B-cell NHL and CLL

• Status: Recruiting
• Trial end date: 2023-12-29
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and recommended Phase 2 dose (RP2D) of JNJ-67856633 and ibrutinib in combination in participants with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) in Part A (Dose Escalation) and to evaluate safety of JNJ-67856633 and ibrutinib in combination, at the RP2D regimen in Part B (Cohort Expansion).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

• Cardiac parameters within the specified range

• Women of childbearing potential must agree to all of the following during the study and for 3 months after the last dose of study drug: a) use a barrier method of contraception; b) use a highly effective contraceptive methods; c) not to donate eggs (ova, oocytes) or freeze them for future use for the purposes of assisted reproduction during the study; d) not to plan to become pregnant; e) not to breast-feed

• Willing and able to adhere to the lifestyle restrictions specified in this protocol

• Participants must have tumor tissue availability

• Adequate organ functions

Exclusion Criteria:

• Known (active) Central Nervous System (CNS) involvement

• Prior treatment with JNJ-67856633 or another MALT1 inhibitor that is associated with disease progression or intolerable toxicities