CAR-T · relapsed/refractory multiple myeloma Phase III clinical trial
Official protocol title:A Randomized Controlled Phase III Clinical Study of Equecabtagene Autoleucel Injection in Patients with Lenalidomide-Refractory Relapsed/Refractory Multiple Myeloma (RRMM)
Trial Summary
This project is a Phase III clinical trial sponsored by Nanjing IASO Biotechnology Co., Ltd., primarily targeting patients with relapsed/refractory multiple myeloma (RRMM) who have received 1 to 2 prior lines of therapy (which must include regimens based on a proteasome inhibitor and an immunomodulatory agent) and are refractory to lenalidomide. The investigational group receives anti-BCMA chimeric antigen receptor T-cell (CAR-T) therapy (equecabtagene autoleucel injection) as a single intravenous infusion; the control group receives standard therapies, consisting of a monoclonal antibody (daratumumab) or a proteasome inhibitor (bortezomib), in combination with an immunomodulatory agent (pomalidomide) and a glucocorticoid (dexamethasone), administered on 3-week or 4-week treatment cycles. This study is a domestic trial without international medical centers and will be conducted across 28 leading domestic medical institutions in China, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology), Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, The First Affiliated Hospital, Zhejiang University School of Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and Beijing Chaoyang Hospital, Capital Medical University.
Participating Centers0 in China + 28 overseas
Source and Verification
Every fact on this page is derived from the official study protocol document below. The source document is archived as a PDF for direct verification.
- Document type
- CDE clinical trial registration filing (original PDF)
- Official registration number
- CTR20241656
- Verify on the NMPA CDE public platformby entering CTR20241656 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
- 2026-09-07
Frequently Asked Questions about this Study
Structured facts derived from official protocol filings for patient and family reference
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.
According to verified protocol filings, key eligibility thresholds include: age 18–75 years, ECOG performance status ≤ 1, 1–2 prior lines of therapy. The study specifies 7 inclusion and 17 exclusion criteria covering detailed organ function and medical history. Final enrollment confirmation is determined by investigators at participating hospital trial centers.
The core therapeutic target or investigational mechanism is [CAR-T]. It aims to selectively eradicate clonal plasma cells or redirect anti-tumor immune responses, representing an active area of precision hematology research.
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.
This is an international multi-centre study with 0 study centres in China and 28 overseas centres. The lead institution is [Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences]. Prominent sites include Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, The First Affiliated Hospital, Zhejiang University School of Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20241656] (CDE_CTR). Patients and researchers can verify registration details and regulatory authorizations directly on the official NMPA CDE platform.
Key Information
Status
Recruiting
Phase
Phase III
Target / Therapy
CAR-T
Sponsor
Nanjing IASO Biotechnology Co., Ltd.
Principal Investigator
Lugui Qiu
Lead Institution
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Participating Centers
0 in China + 28 overseas
CDE Registry ID
CTR20241656
Trial information is translated from the Chinese source record and reviewed by CMDN. Confirm current status and eligibility with the study team.
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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.
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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.
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