Official protocol title:A Phase III, Randomized Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy (Including an Anti-CD38 Antibody and Lenalidomide)
Sponsor: Janssen Research & Development, LLC / Johnson & Johnson (China) Investment Ltd. / Cilag AG / Janssen Pharmaceutica NV; Thermo Electron Limited; Fisher Clinical Services GmbH; Fisher Clinical Services Inc.; Almac Clinical Services; Almac Clinical Services LLCUpdated: 9/4/2026
Target CohortRelapsed/refractory(Synthesized by CMDN from protocol summary; final eligibility confirmed by study doctors)
Trial Summary
This study aims to evaluate the efficacy and safety of JNJ-79635322 versus teclistamab in the treatment of multiple myeloma. The trial mainly enrolls adult participants with relapsed or refractory disease who have received 1 to 3 prior lines of anti-myeloma therapy (including an anti-CD38 antibody and lenalidomide). Eligible participants will be randomized to receive subcutaneous injections of JNJ-79635322 or teclistamab. This is an international multicenter study conducted simultaneously in multiple hospitals, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences.
Participating Centers6 in China + 216 overseas
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Institute of Hematology, CAMS)
The First Affiliated Hospital, Zhejiang University School of Medicine
Sun Yat-sen University Cancer Center
Shanghai Fourth People's Hospital
The Second Affiliated Hospital of Xi'an Jiaotong University
Shengjing Hospital of China Medical University
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing Chao-Yang Hospital, Capital Medical University
The First Affiliated Hospital of Wenzhou Medical University
The First Affiliated Hospital of Nanchang University
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Peking University Shenzhen Hospital
Peking University First Hospital
Tianjin Medical University Cancer Institute and Hospital
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
The First Affiliated Hospital of Guangxi Medical University
Henan Cancer Hospital
The First Hospital of Jilin University
National Taiwan University Hospital
Chang Gung Memorial Hospital
National Cheng Kung University Hospital
Taipei Veterans General Hospital
Taichung Veterans General Hospital
China Medical University Hospital
Box Hill Hospital
Canberra Hospital
Macquarie University Hospital
Royal Perth Hospital
St Vincent s Hospital Sydney
Port Macquarie Base Hospital
Austin Hospital
Hospital Israelita Albert Einstein
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
Clinica Medica Sao Germano LTDA
Irmandade Santa Casa de Misericordia de Porto Alegre - Hospital da Crianca Santo Antonio
Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina
Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Verify on the NMPA CDE public platformby entering CTR20262221 in the registration-number field. The platform is a search interface with no permanent per-study URL, so a direct link is not possible.
Last reconciled
2026-09-04
Frequently Asked Questions about this Study
Structured facts derived from official protocol filings for patient and family reference
QWhich patient group is targeted by this clinical trial?
According to official protocol filings (target population synthesized by CMDN from study details, not an official CDE field), this study is primarily designed for patients with [Relapsed/refractory]. Eligibility requires verified clinical confirmation by investigators regarding prior lines of therapy, active disease biomarkers, and performance status.
QWhat are the specific eligibility criteria regarding age, performance status, and prior therapy?
According to verified protocol filings, key eligibility thresholds include: age ≥ 18 years, ECOG performance status ≤ 2, 1–3 prior lines of therapy. The study specifies 9 inclusion and 13 exclusion criteria covering detailed organ function and medical history. Final enrollment confirmation is determined by investigators at participating hospital trial centers.
QWhat are the investigational targets and mechanism of action?
The core therapeutic target or investigational mechanism is [Trispecific antibody targeting BCMA, GPRC5D, and CD3]. It aims to selectively eradicate clonal plasma cells or redirect anti-tumor immune responses, representing an active area of precision hematology research.
QWhat clinical phase is this study in?
This study is registered as a [Phase III] clinical trial. The protocol is conducted under rigorous ethical and Good Clinical Practice (GCP) oversight approved by institutional ethics committees.
QWhere are the participating hospital trial centers located?
This is an international multi-centre study with 6 study centres in China and 216 overseas centres. The lead institution is [Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Institute of Hematology, CAMS)]. Prominent sites include Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Institute of Hematology, CAMS), The First Affiliated Hospital, Zhejiang University School of Medicine, Sun Yat-sen University Cancer Center, among others. Eligible domestic patients can seek screening at the nearest participating centre.
QWhat is the official trial registration code and how can it be verified?
The official public registration identifier for this protocol is [CTR20262221] (CDE_CTR). Patients and researchers can verify registration details and regulatory authorizations directly on the official NMPA CDE platform.
Note for International Patients: Trial centers for this study are located in China. Interventional trials strictly comply with domestic Human Genetic Resources (HGRAC) regulations and standard hospital protocols, which generally restrict enrollment to residents with domestic healthcare identification. International patients seeking approved cellular therapies should review commercial options.
Key Information
Status
Recruiting
Phase
Phase III
Target / Therapy
Trispecific antibody targeting BCMA, GPRC5D, and CD3
Sponsor
Janssen Research & Development, LLC / Johnson & Johnson (China) Investment Ltd. / Cilag AG / Janssen Pharmaceutica NV; Thermo Electron Limited; Fisher Clinical Services GmbH; Fisher Clinical Services Inc.; Almac Clinical Services; Almac Clinical Services LLC
Principal Investigator
Lugui Qiu
Lead Institution
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Institute of Hematology, CAMS)
International participation must be confirmed directly with the study team. If a clinical trial is not practical, review our independent guide to CAR-T in China.
Protocol drugs and related tests are fully covered by the sponsor. All studies are strictly supervised by ethics committees, and patients retain the legal right to withdraw at any time.
