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    DRUG:

    safimaltib (JNJ-6633)

    i
    Other names: JNJ-6633, JNJ 67856633, JNJ-67856633
    Company:
    J&J
    Drug class:
    MALT1 protein inhibitor
    Related drugs:
    23d
    Therapeutic targeting of MALT1 in oncology: Mechanism, inhibitor development, and clinical prospects. (PubMed, J Cell Commun Signal)
    Notably, agents such as safimaltib (JNJ-67856633) have shown manageable safety profiles and preliminary antitumor activity in early-phase trials for relapsed/refractory B-cell malignancies. However, MALT1-targeted therapy poses a dual challenge: although inhibiting oncogenic signaling and tumor cell proliferation, it also disrupts immunosuppressive Treg function, risking autoimmune toxicity by compromising the tumor microenvironment. This review systematically analyzes MALT1's oncogenic roles across cancers, clarifies inhibitor mechanisms, and evaluates translational challenges and strategic opportunities for precision oncology and combination immunotherapy.
    Review • Journal
    |
    MALT1 (MALT1 Paracaspase)
    |
    safimaltib (JNJ-6633)
    9ms
    A Study of JNJ-67856633 in Participants With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov)
    P1, N=226, Completed, Janssen Research & Development, LLC | Active, not recruiting --> Completed
    Trial completion
    |
    safimaltib (JNJ-6633)
    12ms
    A Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in B-cell NHL and CLL (clinicaltrials.gov)
    P1, N=45, Completed, Janssen Research & Development, LLC | Active, not recruiting --> Completed
    Trial completion
    |
    Imbruvica (ibrutinib) • safimaltib (JNJ-6633)
    1year
    A Study of JNJ-64264681 and JNJ-67856633 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P1, N=75, Completed, Janssen Research & Development, LLC | Active, not recruiting --> Completed | Trial completion date: Apr 2025 --> Jan 2025 | Trial primary completion date: Apr 2025 --> Jan 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    safimaltib (JNJ-6633) • JNJ-4681
    1year
    A Study of JNJ-67856633 in Participants With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov)
    P1, N=226, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Jan 2026 --> Apr 2025
    Trial completion date
    |
    safimaltib (JNJ-6633)
    1year
    A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring (clinicaltrials.gov)
    P1, N=80, Enrolling by invitation, Janssen Research & Development, LLC
    New P1 trial
    |
    Imbruvica (ibrutinib) • safimaltib (JNJ-6633) • JNJ-4681 • JNJ-6665 • JNJ-8902 • onametostat (JNJ-64619178) • rezetamig (JNJ-8780)
    over1year
    A Study of JNJ-67856633 in Participants With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov)
    P1, N=226, Active, not recruiting, Janssen Research & Development, LLC | Trial primary completion date: Dec 2024 --> Apr 2025
    Trial primary completion date
    |
    safimaltib (JNJ-6633)
    over1year
    A Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in B-cell NHL and CLL (clinicaltrials.gov)
    P1, N=45, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2026 --> Apr 2025 | Trial primary completion date: Nov 2024 --> Apr 2025
    Trial completion date • Trial primary completion date
    |
    Imbruvica (ibrutinib) • safimaltib (JNJ-6633)
    over1year
    A Study of JNJ-64264681 and JNJ-67856633 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P1, N=75, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2026 --> Jul 2025
    Trial completion date • Combination therapy
    |
    safimaltib (JNJ-6633) • JNJ-4681
    over1year
    A Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in B-cell NHL and CLL (clinicaltrials.gov)
    P1, N=45, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Nov 2024 --> Dec 2026
    Trial completion date
    |
    Imbruvica (ibrutinib) • safimaltib (JNJ-6633)
    over1year
    A Study of JNJ-64264681 and JNJ-67856633 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P1, N=75, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Jul 2025 --> Dec 2026
    Trial completion date • Combination therapy
    |
    safimaltib (JNJ-6633) • JNJ-4681
    2years
    A Study of JNJ-64264681 and JNJ-67856633 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P1, N=75, Active, not recruiting, Janssen Research & Development, LLC | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial primary completion date • Combination therapy
    |
    safimaltib (JNJ-6633) • JNJ-4681