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

NCT03900598 | Completed Phase 1 FDA Drug

• 4 other identifiers: CR10858767856633LYM10012018-003549-402024-512734-15-00
• Study Type: interventional
• Target: 226
• Locations: 12 countries
• Sites: 47

Brief Summary

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.

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (2)

• Part 1: Dose-Limiting Toxicity (DLT)

  The DLTs are based on drug related adverse events and defined as any of the following events: any toxicity that would require discontinuation of treatment; and/or hematological / non-hematological toxicity of Grade 3 or higher.

  Approximately 21 days

• Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

  An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  Up to 4 years and 11 months

Secondary Outcomes (5)

• JNJ-67856633 Plasma Concentrations

  Up to 4 years and 11 months

• Part 1 and Part 2: Overall Response Rate (ORR)

  Up to 4 years and 11 months

• Part 1 and Part 2: Complete Response Rate

  Up to 4 years and 11 months

• Part 1 and Part 2: Time to Response (TTR)

  Up to 4 years and 11 months

• Part 1 and Part 2: Duration of Response (DoR)

  Up to 4 years and 11 months

Study Arms (2)

Part 1 (Dose Escalation): JNJ-67856633

EXPERIMENTAL

Participants will receive JNJ-67856633 until disease progression, intolerable toxicity, withdrawal of consent, or the investigator or sponsor decision. Subsequent dose levels will be assigned by the sponsor using an adaptive dose escalation strategy based on all available safety, pharmacokinetic (PK), and biomarker data.

Drug: JNJ-67856633

Part 2 (Cohort Expansion): JNJ-67856633

EXPERIMENTAL

Participants will receive JNJ-67856633 at the recommended Phase 2 dose (RP2D) determined in Part 1.

Drug: JNJ-67856633

Interventions

JNJ-67856633 DRUG

JNJ-67856633 capsule will be administered orally.

Part 1 (Dose Escalation): JNJ-67856633; Part 2 (Cohort Expansion): JNJ-67856633

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (47)

City of Hope

Duarte, California, 91010, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MD Anderson

Houston, Texas, 77025, United States

Location

Monash Medical Centre

Clayton, 3168, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, 3000, Australia

Location

Linear Clinical Research Ltd

Nedlands, 6009, Australia

Location

Scientia Clinical Research

Randwick, 2031, Australia

Location

The First Affiliated Hospital of NanChang University

Nanchang, 330006, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

Location

Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science

Tianjin, 300320, China

Location

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, China

Location

Hopital Claude Huriez

Lille, 59037, France

Location

CHU de Nantes hotel Dieu

Nantes, 44093, France

Location

Groupe Hospitalier Pitie Salpetriere

Paris, 75013, France

Location

Institut Curie

Paris, 75248, France

Location

Centre hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

Location

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, 31059, France

Location

CHU Bretonneau

Tours, 37044, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Universitatsklinikum Munster

Münster, 48149, Germany

Location

Universitatsklinikum Ulm

Ulm, 89081, Germany

Location

Alexandra General Hospital of Athens

Athens, 11528, Greece

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Sheba Medical Center

Ramat Gan, 74047, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

Bologna, 40138, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location

National Cancer Center Hospital

Chūōku, 104 0045, Japan

Location

Tokai University Hospital

Isehara, 259-1193, Japan

Location

National Hospital Organization Nagoya Medical Center

Nagoya, 460-0001, Japan

Location

Okayama University Hospital

Okayama, 700 8558, Japan

Location

The Cancer Institute Hospital of JFCR

Tokyo, 135 8550, Japan

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hosp. Univ. Germans Trias I Pujol

Badalona, 8916, Spain

Location

Hospital de Vall D'Hebron

Barcelona, 08035, Spain

Location

Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Location

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, 28223, Spain

Location

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

Location

Hosp. Univ. Marques de Valdecilla

Santander, 39008, Spain

Location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 3, 2019
• Study Start: April 3, 2019
• Primary Completion: May 22, 2025
• Study Completion: May 22, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (4); GB (1); AU (4); GR (1); IL (3); ES (8); KR (3); IT (2); US (6); DE (2); JP (5); FR (8)