NCT03900598CompletedPhase 1
A Study of JNJ-67856633 in Participants With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
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
Source: ClinicalTrials.gov · Last updated 22 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 226 (actual)
- First submitted
- 2 Apr 2019
- Start date
- 3 Apr 2019
- Primary completion date
- 22 May 2025
- Lead sponsor
- Janssen Research & Development, LLC
- NCT number
- NCT03900598
- EU CT number
- 2024-512734-15-00
- EudraCT number
- 2018-003549-40
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 226
- From 3 Apr 2019 to the primary completion date, 22 May 2025
- 41 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Prior treatment with a mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1) inhibitor
Other illness
- 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
Other
- Known active central nervous system (CNS) involvement for dose escalation and specific expansion cohorts as determined by the study evaluation team (SET)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (41)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Medical Centre Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Linear Clinical Research Ltd Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Scientia Clinical Research Coordinator of this site? Confirm its status | Randwick | Australia | Unknown status |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The First Affiliated Hospital of Xian Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Universitätsklinikum Münster Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Universitätsklinikum Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
| Hosp. Univ. Germans Trias I Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hospital de Vall D'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. Univ. 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp Univ Fund Jimenez Diaz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Clinica Univ. de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Hosp. Quiron Madrid Pozuelo Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Unknown status |
| Hosp Clinico Univ de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Hosp. Univ. Marques de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Completed |
| St. Bartholomew's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chūōku | Japan | Unknown status |
| Tokai University Hospital Coordinator of this site? Confirm its status | Isehara | Japan | Unknown status |
| National Hospital Organization Nagoya Medical Center Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| MD Anderson Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.