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NCT07258511PHASE3Recruiting

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

Janssen Research & Development, LLC

Start Date

2/4/2026

Completion Date

9/30/2031

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

Age Range: 18 years to No maximum

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

Interventions

DRUG

JNJ-79635322

DRUG

Teclistamab

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Conditions

Multiple Myeloma

Locations

Mayo Clinic Phoenix

Phoenix, Arizona 85054

United States

UAMS

Little Rock, Arkansas 72205

United States

City of Hope Duarte

Duarte, California 91010

United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California 92618

United States

USC Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

University of California San Francisco

San Francisco, California 94122

United States

Colorado Blood Cancer Institute

Denver, Colorado 80218

United States

University of Connecticut Health Center

Farmington, Connecticut 06030

United States

Yale Cancer Center

New Haven, Connecticut 06510

United States

Florida Cancer Specialists & Research Institute

Fort Myers, Florida 33901

United States

Mayo Clinic Jacksonville

Jacksonville, Florida 32224

United States

Moffit Cancer center

Tampa, Florida 33612

United States

Emory University

Atlanta, Georgia 30322

United States

City of Hope Chicago

Zion, Illinois 60099

United States

University of Iowa Hospital and Clinics

Iowa City, Iowa 52242

United States

Mission Cancer Blood

Waukee, Iowa 50263

United States

University of Kansas Cancer Center

Kansas City, Kansas 66160

United States

Norton Cancer Institute

Louisville, Kentucky 40207

United States

University of Maryland School of Medicine

Baltimore, Maryland 21201

United States

Mayo Clinic Rochester

Rochester, Minnesota 55905

United States

Mount Sinai Brooklyn

Brooklyn, New York 11234

United States

NYU Winthrop

Mineola, New York 11501

United States

Mount Sinai Chelsea

New York, New York 10011

United States

Laura and Isaac Perlmutter Cancer Center NYU ACC

New York, New York 10016

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

University of North Carolina

Chapel Hill, North Carolina 27514

United States

Durham VAMC

Durham, North Carolina 27705

United States

Oregon Health And Science University

Portland, Oregon 97239

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania 19107

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

St. David's South Austin Medical Center

Austin, Texas 78704

United States

Baylor University Medical Center

Dallas, Texas 75246

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

Texas Transplant Institute

San Antonio, Texas 78229

United States

Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

Medical College Of Wisconsin

Milwaukee, Wisconsin 53226

United States

Box Hill Hospital

Box Hill, 3128

Australia

Mater Misericordiae Ltd

Brisbane, 4101

Australia

Monash Medical Centre

Clayton, 3168

Australia

St Vincents Hospital Melbourne

Fitzroy, 3065

Australia

The Alfred Hospital

Melbourne, 3004

Australia

Fiona Stanley Hospital

Murdoch, 6150

Australia

Sir Charles Gairdner Hospital

Nedlands, 6009

Australia

Gold Coast University Hospital

Southport, 4215

Australia

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta T2N 4N1

Canada

British Columbia Cancer Agency

Vancouver, British Columbia V5Z4E6

Canada

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia B3H 3A7

Canada

Juravinski Cancer Centre

Hamilton, Ontario L8V5C2

Canada

London Health Sciences Centre

London, Ontario N6A 5W9

Canada

University Health Network UHN Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada

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

Montreal, Quebec H1T 2M4

Canada

Peking University People's Hospital

Beijing, 100044

China

Sun Yat Sen University Cancer Center

Guangzhou, 510060

China

First affiliated Hospital of Zhejiang University

Hangzhou, 310003

China

Nanjing Drum Tower Hospital

Nanjing, 210008

China

The First Affiliated Hospital of Guangxi Medical University

Nanning, 530021

China

Shanghai Fourth People s Hospital

Shanghai, 200434

China

Hospices Civils de Lyon HCL

Lyon, 69002

France

Hotel Dieu CHU de Nantes

Nantes, 44000

France

Hopital Saint Louis APHP

Paris, 75010

France

APHP

Paris, 75012

France

CHU de Bordeaux - Hospital Haut-Leveque

Pessac, 33600

France

CHU Toulouse

Toulouse, 31300

France

CHRU de Tours

Tours, 37000

France

Marien Hospital Dusseldorf

Düsseldorf, 40479

Germany

Universitaetsklinikum Heidelberg

Heidelberg, 69120

Germany

Universitatsklinikum Jena

Jena, 07747

Germany

Universitaetsklinikum Wuerzburg

Würzburg, 97080

Germany

Evangelismos S A

Athens, 106 76

Greece

Alexandra General Hospital of Athens

Athens, 11528

Greece

Theageneio Cancer Hospital

Thessaloniki, 546 39

Greece

Geniko Nosokomeio Thessalonikis George Papanikolaou

Thessaloniki, 570 10

Greece

Soroka Medical Center

Beersheba, 8457108

Israel

Bnai Zion Medical Center

Haifa, 31048

Israel

Rambam Medical Center

Haifa, 3109601

Israel

Carmel Medical Center

Haifa, 34362

Israel

Shaare Zedek MC

Jerusalem, 9103102

Israel

Sheba Medical Center

Ramat Gan, 52621

Israel

Baruch Padeh MC

Ramat Poriya, 1520800

Israel

Assuta MC

Tel Aviv, 69710

Israel

A.O.U. SS. Antonio e Biagio e Cesare Arrigo

Alessandria, 15121

Italy

Spedali Civili di Brescia

Brescia, 25123

Italy

Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano

Milan, 20122

Italy

Ospedale Santa Chiara AO Universitaria Pisana

Pisa, 56126

Italy

Arcispedale Santa Maria Nuova - IRCCS

Reggio Emilia, 42123

Italy

Campus Bio Medico di Roma

Roma, 00128

Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, 00168

Italy

Humanitas Hospital

Rozzano, 20089

Italy

Casa Sollievo Della Sofferenza IRCCS

San Giovanni Rotondo, 71013

Italy

U.O. Ematologia Ospedale San Bortolo

Vicenza, 36100

Italy

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyō City, 113 8677

Japan

Chiba Cancer Center

Chiba, 260 0801

Japan

Shonan Kamakura General Hospital

Kamakura-shi, 247-8533

Japan

Kameda Medical Center

Kamogawa, 296-8602

Japan

Yamanashi Prefectural Central Hospital

Kofu, 400-0027

Japan

The Jikei University Hospital

Minato, 105-8471

Japan

Japanese Red Cross Medical Center

Shibuya City, 150-8935

Japan

Kanagawa Cancer Center

Yokohama, 241 8515

Japan

VU Medisch Centrum

Amsterdam, 1081 HV

Netherlands

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ

Netherlands

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, 3435 CM

Netherlands

Radboud Umcn

Nijmegen, 6525 GA

Netherlands

Erasmus MC

Rotterdam, 3015

Netherlands

Haga ziekenhuis

The Hague, 2545 AA

Netherlands

Akershus Universitetssykehus

Lorenskog, 1478

Norway

Oslo University Hospital HF Ulleval sykehus

Oslo, 0450

Norway

Stavanger University Hospital Ullandhaug

Stavanger, 4021

Norway

St. Olavs Hospital

Trondheim, 7030

Norway

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916

Spain

H. Vall D'Hebron

Barcelona, 08035

Spain

Hosp. Clinic de Barcelona

Barcelona, 08036

Spain

Hosp. Univ. Virgen de Las Nieves

Granada, 18014

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, 28223

Spain

Hosp Clinico Univ de Salamanca

Salamanca, 37007

Spain

Hosp. Univ. I Politecni La Fe

Valencia, 46026

Spain

Kent and Canterbury Hospital

Canterbury, CT1 3NG

United Kingdom

Cardiff and Vale UHB - University Hospital of Wales

Cardiff, CF14 4XW

United Kingdom

Ninewells Hospital & Medical School

Dundee, DD1 9SY

United Kingdom

University College London Hospitals

London, NW1 2PG

United Kingdom

Nottingham City Hospital

Nottingham, NG5 1PB

United Kingdom

Queen Alexandra Hospital

Portsmouth, PO6 3LY

United Kingdom

Royal Marsden Hospital

Sutton, SM2 5PT

United Kingdom