67856633LYM1002
Research type
Research Study
Full title
A Phase 1b Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in Relapsed or Refractory B cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
IRAS ID
305381
Contact name
Shirley D'Sa
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2021-000191-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 13 days
Research summary
This is a phase 1b study of JNJ-67856633 and Ibrutinib (the study drugs) in combination in relapsed or refractory B-cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukaemia (CLL).
JNJ-67856633 is an oral inhibitor of mucosa-associated lymphoid tissue lymphoma translocation protein-1 (MALT1). MALT1 is a protein involved in the production and growth of B-cell lymphomas. Ibrutinib is an oral inhibitor of Bruton’s tyrosine kinase (BTK). BTK is a protein involved in the growth of cancer cells in B-cell lymphomas and leukaemia.
The purpose of the study is to find the right dose(s) for the combination of JNJ-67856633 and ibrutinib that may treat B-cell NHL or CLL and see if the combination of JNJ-67856633 and ibrutinib is safe and effective for treating patients with B-cell NHL or CLL. Another purpose is to find out how long the combination of JNJ-67856633 and ibrutinib stays in and acts on the body and how the body responds to it. The study will also look at the effects on disease and any side effects.
There are 2 parts of this study. The first part (Part A) is to determine the right dose(s) of the combination of JNJ-67856633 and ibrutinib that is/are safe to give to patients with B-cell NHL or CLL. Once the recommended dose(s) of the combination of JNJ 67856633 and ibrutinib is determined, the second part (Part B) of the study will begin which will further evaluate the safety and preliminary activity for the combination of JNJ-67856633 and ibrutinib. Participants in Part A and Part B will undertake the same study schedule, with dosages of study treatment dependent on which part and cohort of the study a participant is entered in to.
The study will consist of a Screening Phase, a Treatment Phase, and a Post-Treatment Follow-up Phase.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0400
Date of REC Opinion
2 Feb 2022
REC opinion
Further Information Favourable Opinion