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A Study of JNJ-67856633 in Participants With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

Trial Status: Active

The purpose of this study is to determine the recommended Phase 2 dose regimen or the maximum tolerated dose of JNJ-67856633 in participants with relapsed / refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia.

Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
  • Cardiac parameters within the following range: corrected QT interval (QTc intervals corrected using Fridericia's formula [QTcF]) less than or equal to (<=)480 milliseconds based on the average of triplicate assessments performed no more than 5 minutes apart (plus minus [+-]3 minutes)
  • Women of childbearing potential must have a negative highly sensitive serum (Beta human chorionic gonadotropin) at screening and prior to the first dose of study drug, and until 30 days after the last dose
  • In addition to the user-independent, highly effective method of contraception, a male or female condom with or without spermicide is required, example, condom with spermicidal foam/gel/film/cream/suppository. Male condom and female condom should not be used together (due to risk of failure with friction)
  • Men must wear a condom when engaging in any activity that allows for passage of ejaculate to another person. Male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak

Exclusion Criteria

  • Known active central nervous system (CNS) involvement for dose escalation and specific expansion cohorts as determined by the study evaluation team (SET)
  • Prior solid-organ transplantation
  • Either of the following: a) Received an autologous stem cell transplant less than or equal to (<=)3 months before the first dose of study drug. b) Prior treatment with allogenic stem cell transplant <=6 months before the first dose of study drug, has evidence of graft versus host disease, or requires immunosuppressant therapy for graft versus host disease within the last 4 weeks
  • History of malignancy (other than the disease under study in the cohort to which the participant is assigned) within 1 year prior to the first administration of study drug. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy which in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 1 year before the first dose of study drug. Concomitant malignancies that are unlikely to progress and/or preclude evaluation of study endpoints may be allowed after discussion with the Study Responsible Physician
  • Prior treatment with a mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1) inhibitor

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE

Nebraska

Omaha
University of Nebraska Medical Center
Status: APPROVED

New York

New York
Icahn School of Medicine at Mount Sinai
Status: ACTIVE
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: APPROVED

Non-Hodgkin lymphoma (NHL) represents a diverse set of diseases. Among them diffuse large

B-cell lymphoma (DLBCL) represents the most common subtype of NHL, accounting for 30 percent

(%) to 40% of all newly diagnosed cases. Mucosa-associated lymphoid tissue lymphoma

translocation protein 1 (MALT1) is a key mediator of the nuclear factor

kappa-light-chain-enhancer of activated B cells (NF-kappaB) signaling pathway and has been

shown to play a critical role in different types of lymphoma, including activated B cell-like

(ABC) subtype of diffuse large B-cell lymphoma (DLBCL). JNJ-67856633 is a MALT1 inhibitor and

will be administered orally. The study will evaluate the following: Dose Escalation (Part 1):

One or more recommended Phase 2 dose (RP2Ds) of JNJ-67856633. Cohort Expansion (Part 2):

JNJ-67856633 is well tolerated and achieves antitumor responses at the RP2D. The study

consists of screening phase (less than or equal to 28 days before first dose), treatment

phase (from Cycle 1 Day 1 till end of treatment visit [within 30 (+7) days after the last

dose]) and post-treatment phase. A prescreening period may also apply to participants in

select cohorts in Part 2. The total study duration will be approximately 4 years and 11

months. Efficacy assessments will include radiographic image assessments, positron emission

tomography scan, bone marrow assessment, endoscopy or colonoscopy etc. Safety will be

monitored throughout the study.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Janssen Research & Development, LLC

  • Primary ID CR108587
  • Secondary IDs NCI-2019-02910, 2018-003549-40, 67856633LYM1001
  • Clinicaltrials.gov ID NCT03900598