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Leukemia, Lymphocytic, Chronic, B-CellPhase 1NCT03900598

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

A Phase 1 study testing JNJ-67856633 in people with Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma, Non-Hodgkin, run by Janssen Research & Development, LLC at 47 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
JNJ-67856633
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
47 sitesin 12 countries
Study dates
3 Apr 2019to 22 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

47 sites in 12 countries.

47 sites in 12 countries

France8 sites

  • Hopital Claude Huriez

    Lille, 59037

  • CHU de Nantes hotel Dieu

    Nantes, 44093

  • Groupe Hospitalier Pitie Salpetriere

    Paris, 75013

  • Institut Curie

    Paris, 75248

  • Centre hospitalier Lyon-Sud

    Pierre-Bénite, 69495

  • Institut Universitaire du Cancer Toulouse - Oncopole

    Toulouse, 31059

  • CHU Bretonneau

    Tours, 37044

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Spain8 sites

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 8916

  • Hospital de Vall D'Hebron

    Barcelona, 08035

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

Other trials in Spain

United States6 sites

  • City of Hope

    Duarte, California, 91010

  • MD Anderson

    Houston, Texas, 77025

  • Weill Cornell Medicine

    New York, New York, 10021

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

Other trials in United States

Japan5 sites

  • National Cancer Center Hospital

    Chūōku, 104 0045

  • Tokai University Hospital

    Isehara, 259-1193

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001

  • Okayama University Hospital

    Okayama, 700 8558

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550

Other trials in Japan

Australia4 sites

  • Monash Medical Centre

    Clayton, 3168

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

  • Linear Clinical Research Ltd

    Nedlands, 6009

  • Scientia Clinical Research

    Randwick, 2031

Other trials in Australia

China4 sites

  • The First Affiliated Hospital of NanChang University

    Nanchang, 330006

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300060

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

    Tianjin, 300320

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an

Other trials in China

Israel3 sites

  • Hadassah Medical Center

    Jerusalem, 91120

  • Sheba Medical Center

    Ramat Gan, 74047

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

South Korea3 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Germany2 sites

  • Universitatsklinikum Munster

    Münster, 48149

  • Universitatsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Italy2 sites

  • Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

    Bologna, 40138

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

Other trials in Italy

Greece1 site

  • Alexandra General Hospital of Athens

    Athens, 11528

Other trials in Greece

United Kingdom1 site

  • St Bartholomew's Hospital

    London, EC1A 7BE

Other trials in United Kingdom

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
JNJ-67856633
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-67856633Drug

    JNJ-67856633 capsule will be administered orally.

Study groups in NCT03900598
Study groupRoleWhat they receive
Part 1 (Dose Escalation): JNJ-67856633ExperimentalParticipants 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.
Receives: Drug: JNJ-67856633
Part 2 (Cohort Expansion): JNJ-67856633ExperimentalParticipants will receive JNJ-67856633 at the recommended Phase 2 dose (RP2D) determined in Part 1.
Receives: Drug: JNJ-67856633

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Approximately 21 days

  2. 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.

    Measured: Up to 4 years and 11 months

Secondary outcomes (5)

  1. JNJ-67856633 Plasma Concentrations

    Concentration assessment will be done to evaluate the effect of JNJ-67856633.

    Measured: Up to 4 years and 11 months

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

    ORR is defined as the percentage of participants who have a partial response (PR) and complete response (CR) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL), non-Hodgkin lymphoma and Waldenstrom macroglobulinemia response criteria.

    Measured: Up to 4 years and 11 months

  3. Part 1 and Part 2: Complete Response Rate

    Complete response rate is defined as the percentage of participants who achieve a best response of CR according to the iwCLL, non-Hodgkin lymphoma and Waldenstrom macroglobulinemia response criteria.

    Measured: Up to 4 years and 11 months

  4. Part 1 and Part 2: Time to Response (TTR)

    TTR is defined for participants who achieved PR or CR as the time from the first dose of study drug to first response of PR or CR.

    Measured: Up to 4 years and 11 months

  5. Part 1 and Part 2: Duration of Response (DoR)

    DoR is defined for participants who achieved PR or CR as the time between the date of initial documentation of PR or CR to the date of first documented evidence of disease progression or death, whichever comes first.

    Measured: Up to 4 years and 11 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2019
  2. Study start3 Apr 2019
  3. Primary completion22 May 2025
  4. Study completion22 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03900598
Sponsor's protocol ID
CR108587
Other IDs
67856633LYM1001, 2018-003549-40, 2024-512734-15-00, 2018
Status last verified
Jun 2025
First submitted
2 Apr 2019
Last updated
22 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-67856633 in people with Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma, Non-Hodgkin, run by Janssen Research & Development, LLC at 47 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in France, Spain, United States, Japan, Australia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Dose-Limiting Toxicity (DLT) (time frame: Approximately 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03900598.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.

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