A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma

Last updated: May 7, 2026
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Multiple Myeloma

Bone Neoplasm

Lymphoproliferative Disorders

Treatment

Teclistamab

JNJ-79635322

Clinical Study ID

NCT07258511
79635322MMY3001
79635322MMY3001
2025-522007-18-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate how well JNJ-79635322 works when compared with an anti-B-cell maturation antigen (BCMA)xCD3 bispecific antibody.

Eligibility Criteria

Inclusion

Inclusion:

  • Documented diagnosis of multiple myeloma (MM) as defined by the criteria below:
  1. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria

  2. Measurable disease at screening as assessed by central laboratory

  • Received at least 3 prior lines of antimyeloma therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD)38 antibody

  • Documented evidence of progressive disease (PD) or failure to achieve a response (that is partial response [PR] or better) to the last line of therapy based on investigator's determination of response by IMWG criteria

  • Have discontinued concurrent use of any other anticancer treatment (including nonpalliative radiotherapy) or investigational agent

  • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the start of study treatment administration

Exclusion:

  • Active hepatitis of infectious origin

  • Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM

  • Suspected or known allergies, hypersensitivity, or intolerance to the excipients of JNJ-79635322 and Teclistamab

  • Major surgery , (example, requiring general anesthesia) within 2 weeks before first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study

  • Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment, during, or within 90 days after the last dose of study treatment

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Teclistamab
Phase: 3
Study Start date:
February 04, 2026
Estimated Completion Date:
September 30, 2031

Connect with a study center

  • Box Hill Hospital

    Box Hill, 3128
    Australia

    Active - Recruiting

  • Box Hill Hospital

    Box Hill 2174360, 3128
    Australia

    Site Not Available

  • Mater Misericordiae Ltd

    Brisbane, 4101
    Australia

    Active - Recruiting

  • Monash Medical Centre

    Clayton, 3168
    Australia

    Active - Recruiting

  • St Vincents Hospital Melbourne

    Fitzroy, 3065
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, 3004
    Australia

    Active - Recruiting

  • Fiona Stanley Hospital

    Murdoch, 6150
    Australia

    Active - Recruiting

  • Mater Hospital Brisbane

    South Brisbane 2207259, 4101
    Australia

    Site Not Available

  • Gold Coast University Hospital

    Southport, 4215
    Australia

    Active - Recruiting

  • Gold Coast University Hospital

    Southport 2148928, 4215
    Australia

    Site Not Available

  • Hospital De Clinicas De Porto Alegre

    Porto Alegre, 90035 903
    Brazil

    Suspended

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta T2N 4N1
    Canada

    Active - Recruiting

  • Soroka Medical Center

    Beersheba, 8457108
    Israel

    Active - Recruiting

  • Soroka Medical Center

    Beersheba 295530, 8457108
    Israel

    Site Not Available

  • Bnai Zion Medical Center

    Haifa, 31048
    Israel

    Active - Recruiting

  • Carmel Medical Center

    Haifa, 34362
    Israel

    Active - Recruiting

  • Rambam Medical Center

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Bnai Zion Medical Center

    Haifa 294801, 31048
    Israel

    Site Not Available

  • Carmel Medical Center

    Haifa 294801, 34362
    Israel

    Active - Recruiting

  • Rambam Medical Center

    Haifa 294801, 3109601
    Israel

    Active - Recruiting

  • Shaare Zedek MC

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Shaare Zedek MC

    Jerusalem 281184, 9103102
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan 293788, 52621
    Israel

    Site Not Available

  • Baruch Padeh MC

    Ramat Poriya, 1520800
    Israel

    Active - Recruiting

  • Assuta MC

    Tel Aviv, 69710
    Israel

    Active - Recruiting

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Bunkyō City, 113 8677
    Japan

    Active - Recruiting

  • Chiba Cancer Center

    Chiba, 260 0801
    Japan

    Active - Recruiting

  • Shonan Kamakura General Hospital

    Kamakura-shi, 247-8533
    Japan

    Active - Recruiting

  • Kameda Medical Center

    Kamogawa, 296-8602
    Japan

    Active - Recruiting

  • Yamanashi Prefectural Central Hospital

    Kofu, 400-0027
    Japan

    Active - Recruiting

  • The Jikei University Hospital

    Minato, 105-8471
    Japan

    Active - Recruiting

  • Japanese Red Cross Medical Center

    Shibuya City, 150-8935
    Japan

    Active - Recruiting

  • Kanagawa Cancer Center

    Yokohama, 241 8515
    Japan

    Active - Recruiting

  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG
    United Kingdom

    Active - Recruiting

  • Ninewells Hospital & Medical School

    Dundee, DD1 9SY
    United Kingdom

    Active - Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • University of Connecticut Health Center

    Farmington, Connecticut 06030
    United States

    Active - Recruiting

  • Yale Cancer Center

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Florida Cancer Specialists & Research Institute

    Fort Myers, Florida 33901
    United States

    Active - Recruiting

  • Moffit Cancer center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Mission Cancer Blood

    Waukee, Iowa 50263
    United States

    Active - Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky 40207
    United States

    Active - Recruiting

  • Mount Sinai Brooklyn

    Brooklyn, New York 11234
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Mount Sinai Chelsea

    New York, New York 10011
    United States

    Active - Recruiting

  • Durham VAMC

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Oregon Health And Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

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