A Phase 1 Study of JNJ-67856633 in Participants With NHL and CLL
Research type
Research Study
Full title
A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-67856633, an Inhibitor of MALT1, in Participants With NHL and CLL
IRAS ID
301516
Contact name
Shirley D'Sa
Contact email
s.d'sa@nhs.net
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2018-003549-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, days
Research summary
Research Summary:
This is a phase 1, first-in-human, open-label study of the safety, pharmacokinetics (the movement of a drug into, through, and out of the body), and pharmacodynamics (how a drug effects the body) of JNJ-67856633 in participants With B cell Non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukaemia (CLL).
JNJ-67856633, the study drug, is an oral inhibitor of MALT1 (Mucosa-associated lymphoid tissue lymphoma translocation protein 1). MALT1 is a protein involved in the production and growth of B-cell lymphomas. This study will test to see if JNJ-67856633 can reverse the effects of MALT1 in humans and help stop the growth of cancers.
There are 2 parts of this study. The first part (1) is to determine the dose of JNJ-67856633 that is safe to give to patients with NHL or CLL. Once the recommended dose of JNJ-67856633 is determined, the second part (2) of the study will further evaluate the safety and activity of JNJ-67856633.
This study will consist of a Pre-screening Phase (for participants in some Part 2 cohorts), a Screening Phase, a Treatment Phase of 21-day treatment cycles, and a Post-Treatment Follow-up Phase.
Summary of results:
No lay summary for this study.
As this is a Phase 1 study, results are not required for submission to clinicaltrials.gov
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
21/YH/0198
Date of REC Opinion
8 Oct 2021
REC opinion
Further Information Favourable Opinion