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

  • STATUS
    Recruiting
  • End date
    May 1, 2024
  • participants needed
    100
  • sponsor
    Janssen Research & Development, LLC
Updated on 23 May 2022
chronic lymphocytic leukemia
lymphoma
leukemia
ibrutinib

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).

Description

Non-Hodgkin lymphoma (NHL) represents the most frequent hematologic malignancy in the world and represents a diverse set of diseases. JNJ-67856633-ZAF (referred as JNJ-67856633) is an orally bioavailable, potent, and selective first-in-class mucosa-associated lymphoid tissue lymphoma translocation protein-1 (MALT1) inhibitor. JNJ-67856633 binds to an allosteric site on MALT1 with a mixed-type mechanism. Ibrutinib is a first-in-class, orally administered, potent, orally administered covalently binding small-molecule inhibitor of Bruton's tyrosine kinase (BTK), as well as interleukin-2-inducible kinase (ITK), a tyrosine protein (Tec) kinase family member present in T cells. The study will be conducted in 2 parts: Part A (Dose Escalation) and Part B (Expansion Phase). In dose escalation phase, one or more recommended Phase 2 dose (RP2Ds) of JNJ-67856633 will be determined. After the RP2D(s) is determined in the dose escalation phase, expansion phase will be conducted. The study is divided into 3 periods: a screening phase, a treatment phase, and a post-treatment follow-up phase. Efficacy assessments will include radiographic image assessments, positron emission tomography scan, bone marrow assessment, endoscopy etc. Safety assessment like physical examination, vital signs, electrocardiogram (ECG), eastern cooperative oncology group (ECOG) performance status, and adverse events monitoring will be performed during the study. Total duration of the study will be up to 2 years and 6 months.

Details
Condition Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin
Treatment Ibrutinib, JNJ-67856633
Clinical Study IdentifierNCT04876092
SponsorJanssen Research & Development, LLC
Last Modified on23 May 2022

Eligibility

Yes No Not Sure

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
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