Recruiting
Phase 3

JNJ-79635322 vs. BCMAxCD3

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07258511

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JNJ-79635322

Teclistamab

Study Details

Brief 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.

Conditions

Multiple Myeloma

Study ID

NCT07258511

Start date

Feb 4, 2026

Status verified date

Aug, 2026

Completion date

Sep 30, 2031

Anticipated

Primary completion date

Dec 12, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 to the last line of therapy based on investigator's determination of response by IMWG criteria
  • Toxicity related to previous anticancer therapy must have resolved to Grade 1 or better
  • 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, or during study treatment

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: JNJ-79635322

Participants will receive subcutaneous (SC) dose of JNJ-79635322 until progressive disease (PD) or intolerable toxicity.

active comparator: Anti BCMAxCD3 Bispecific Antibody

Participants will receive teclistamab (an Anti BCMAxCD3 bispecific anitbody) as a SC injection until PD or intolerable toxicity.

Interventions

JNJ-79635322

JNJ-79635322 will be administered as SC injection.

Teclistamab

Teclistamab will be administered as SC injection.

Primary outcome measure

  • Overall Response [ Time Frame: Up to 5 years and 7 months ]
  • Progression-Free Survival (PFS) [ Time Frame: Up to 5 years and 7 months ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

Mayo Clinic Phoenix

Recruiting

Phoenix, Arizona, United States, 85054

UAMS

Recruiting

Little Rock, Arkansas, United States, 72205

City of Hope Duarte

Recruiting

Duarte, California, United States, 91010

City of Hope Orange County Lennar Foundation Cancer Center

Recruiting

Irvine, California, United States, 92618

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

University of California San Francisco

Recruiting

San Francisco, California, United States, 94122

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

University of Connecticut Health Center

Recruiting

Farmington, Connecticut, United States, 06030

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Florida Cancer Specialists & Research Institute

Recruiting

Fort Myers, Florida, United States, 33901

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Moffit Cancer center

Recruiting

Tampa, Florida, United States, 33612

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

City of Hope Chicago

Recruiting

Zion, Illinois, United States, 60099

University of Iowa Hospital and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Mission Cancer Blood

Recruiting

Waukee, Iowa, United States, 50263

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Norton Cancer Institute

Recruiting

Louisville, Kentucky, United States, 40207

University of Maryland School of Medicine

Recruiting

Baltimore, Maryland, United States, 21201

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Mount Sinai Brooklyn

Recruiting

Brooklyn, New York, United States, 11234

NYU Winthrop

Recruiting

Mineola, New York, United States, 11501

Mount Sinai Chelsea

Recruiting

New York, New York, United States, 10011

Laura and Isaac Perlmutter Cancer Center NYU ACC

Recruiting

New York, New York, United States, 10016

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27514

Durham VAMC

Recruiting

Durham, North Carolina, United States, 27705

Oregon Health And Science University

Recruiting

Portland, Oregon, United States, 97239

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

St. David's South Austin Medical Center

Recruiting

Austin, Texas, United States, 78704

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Texas Transplant Institute

Recruiting

San Antonio, Texas, United States, 78229

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Medical College Of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Arthur J E Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 4N1

British Columbia Cancer Agency

Recruiting

Vancouver, British Columbia, Canada, V5Z4E6

Queen Elizabeth II Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A7

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V5C2

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

University Health Network UHN Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont

Recruiting

Montreal, Quebec, Canada, H1T 2M4

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.