NCT04657224 is a Phase 1 clinical trial of JNJ-64264681 in Lymphoma, Non-Hodgkin, sponsored by Janssen Research & Development, LLC.

Who is sponsoring NCT04657224?

NCT04657224 is sponsored by Janssen Research & Development, LLC.

What drugs are being tested in NCT04657224?

Interventions in NCT04657224: JNJ-64264681, JNJ-67856633.

What condition does NCT04657224 study?

NCT04657224 studies Lymphoma, Non-Hodgkin, Chronic Lymphocytic Leukemia.

Is NCT04657224 still recruiting?

NCT04657224 is currently completed. Last updated 21 August 2025.

Last reviewed 2025-08-21 · How we verify

NCT04657224

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of JNJ-64264681 and JNJ-67856633 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

Completed Phase 1 Last updated 21 August 2025

What this trial tests

Phase 1 trial testing JNJ-64264681 in Lymphoma, Non-Hodgkin in 75 participants. Completed in 16 January 2025.

Timeline

25 February 2021

Primary endpoint
16 January 2025

16 January 2025

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	75
Start date	25 February 2021
Primary completion	16 January 2025
Estimated completion	16 January 2025
Sites	28 locations across Georgia, France, Netherlands, Ukraine, Belgium, Israel, Moldova, Poland

Drugs / interventions tested

JNJ-64264681 — full drug profile →
JNJ-67856633 — full drug profile →

Conditions studied

Lymphoma, Non-Hodgkin — all drugs for Lymphoma, Non-Hodgkin →
Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

18 and older, any sex, with Lymphoma, Non-Hodgkin or Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of this study is to determine: the recommended Phase 2 doses (RP2Ds) of JNJ-64264681 and JNJ 67856633 when administered together in participants with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) (Part A - Dose Escalation); and the safety of the RP2Ds for this combination in different histologies/participant populations (Part B - Cohort Expansion).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Cotargeting of BTK and MALT1 overcomes resistance to BTK inhibitors in mantle cell lymphoma.
Jiang VC, Liu Y, Lian J, Huang S, et al · · 2023 · cited 28× · PMID 36719376 · DOI 10.1172/jci165694
Combining precision oncology and immunotherapy by targeting the MALT1 protease.
Mempel TR, Krappmann D. · · 2022 · cited 19× · PMID 36270731 · DOI 10.1136/jitc-2022-005442
Oncogene-induced MALT1 protease activity drives posttranscriptional gene expression in malignant lymphomas.
Wimberger N, Ober F, Avar G, Grau M, et al · · 2023 · cited 14× · PMID 37623434 · DOI 10.1182/blood.2023021299
A small-molecule inhibitor of BCL10-MALT1 interaction abrogates progression of diffuse large B cell lymphoma.
Kang H, Maurer LM, Cheng J, Smyers M, et al · · 2025 · cited 4× · PMID 40231473 · DOI 10.1172/jci164573
Targeted Agents in the Treatment of Indolent B-Cell Non-Hodgkin Lymphomas.
Minson A, Tam C, Dickinson M, Seymour JF. · · 2022 · cited 4× · PMID 35267584 · DOI 10.3390/cancers14051276
Enforced CARD11/MALT1 signaling in dendritic cells triggers hemophagocytic lymphohistiocytosis.
Isay SE, Vornholz L, Schnalzger T, Groll T, et al · · 2024 · cited 3× · PMID 39661061 · DOI 10.1073/pnas.2413162121
Therapeutic targeting of MALT1 in oncology: Mechanism, inhibitor development, and clinical prospects.
Cao X, Wang P, Ji Y, Sun Y, et al · · 2026 · PMID 41783325 · DOI 10.1002/ccs3.70066

Verify or expand the search:

Other trials of JNJ-64264681

Trials testing the same drug.

NCT06788509 — A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring · Phase 1 · enrolling by invitation
NCT04210219 — A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia · Phase 1 · completed
NCT03607513 — A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-64264681 in Healthy Male and Female Partici · Phase 1 · completed

Other recruiting trials for Lymphoma, Non-Hodgkin

Currently open trials in the same condition.

NCT07308132 — A Study of JNJ-95566692 in Participants With Non-Hodgkin Lymphoid Malignancies · Phase 1 · recruiting
NCT06923397 — Interrupting Sedentary Time to Improve Cardiometabolic Health and Toxicity in Patients With Lymphoma Receiving Chemother · NA · recruiting
NCT06660563 — A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell No · Phase 1 · active not recruiting
NCT06343311 — T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) · Phase 1, PHASE2 · recruiting
NCT06470438 — A Study of JNJ-88998377 for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma · Phase 1 · active not recruiting

Other Janssen Research & Development, LLC trials

Trials by the same sponsor.

NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC · recruiting
NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04657224 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
Last refreshed: 21 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04657224.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing