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

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04876092
Phase
PHASE1
Status
Completed

Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma, Non-Hodgkin

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JNJ-67856633 — DRUG
    Participants will receive JNJ-67856633 orally.
  • Ibrutinib — DRUG
    Participants will receive Ibrutinib orally.

Study Details

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).

Key Dates

Start date
Jul 28, 2021
Status verified
Aug 2025
Primary completion
Feb 13, 2025
Completion
Feb 13, 2025

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: JNJ-67856633 and Ibrutinib
    Participants will receive JNJ-67856633 together with Ibrutinib orally on a 21-day cycle. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET).

Primary Outcome Measure

Percentage of Participants with Dose-Limiting Toxicity (DLT) [ Time Frame: Up to 21 days ]

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