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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

Clinical Trial Details

JNJ-67856633 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 your cancer. 

The main purpose of this study is to find out the side effects (unexpected or unwanted reactions from taking a drug) JNJ-67856633 causes and to find out how the drug should be given for patients with B cell non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Another purpose is to find out how long JNJ-67856633 stays in and acts on your body, and how your body responds to it. 

This is the first time that JNJ-67856633 has been used in humans. Treatment will start with a low dose. After a review of the results obtained at each dose level, it will be decided whether or how much to increase the dose for the next group of patients. Which dose you receive depends on when you are enrolled in the study. 

Key Eligibility: 

This study is open to men and women above the age of 18 who have histologic documentation of B-cell NHL or CLL requiring therapy.

Further details regarding eligibility will be discussed and reviewed when you contact the study team. 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Amelyn Rodriguez, RN
(212) 746-1362
amr2017@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1907020526

ClinicalTrials.gov:

NCT03900598

Sponsor:

67856633LYM1001

Status

Open to Enrollment

Age Group

Adult

Sponsor