64264681LYM1002 - BTK and MALT 1 Combination Trial
Research type
Research Study
Full title
A Phase 1b, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64264681 in Combination with JNJ-67856633 in Participants with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
IRAS ID
291248
Contact name
Toby Eyre
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2020-003149-12
Duration of Study in the UK
2 years, 0 months, 16 days
Research summary
This is a Phase 1b open label study and the first time the combination of 2 new study drugs, JNJ-64264681 and JNJ-67856633, are being given to humans. Both JNJ-64264681 and JNJ-67856633 are investigational drugs with safety information from first in human studies and non-clinical studies. JNJ64264681 is a second generation, orally active, irreversible covalent BKT inhibitor. Given its BTK inhibitory potency, along with nonclinical data to date, JNJ-64264681 is likely to have similar anti-lymphoma activity to already approved BTK inhibitors. This will be given in combination with JNJ-67856633. JNJ-67856633 is an orally bioavailable, potent and allosteric inhibitor of MALT 1 that has demonstrated promising clinical trials and favorable toxicity profile in a Phase 1 study. \nThe purpose of this study is to find the right dose(s) for the combination of JNJ-64264681 and JNJ-67856633 that may treat B-cell Non-Hodgkin’s Lymphoma (B-cell NHL) or Chronic Lymphocytic Leukemia (CLL) and see if the combination of JNJ-64264681 and JNJ-67856633 is safe and effective for treating patients with B-cell NHL or CLL. There will be approximately 135 patients enrolled into this study over a number of cohorts. Participants will receive JNJ-64264681 and JNJ-67856633 administered together until disease progression, intolerable toxicity, withdrawal of consent or the investigator deems that it is in the best interest of the participant to discontinue.\nThe study will be conducted in 2 Parts, Part A - Dose Escalation, of the study is to determine the recommended phase 2 doses (RP2Ds) for JNJ-64264681 and JNJ-67856633 when administered together and Part B Cohort Expansion, is designed to further assess the safety as well as preliminary clinical activity of the RP2Ds of NJ-64264681 and JNJ-67856633 when administered together in participants with specific subtypes of B cell NHL or CLL.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0443
Date of REC Opinion
20 Jan 2021
REC opinion
Further Information Favourable Opinion