Autologous anti-BCMA CAR-T · relapsed/refractory multiple myeloma Phase Ib/II clinical trial
Official protocol title:A Phase Ib/II Clinical Study of CBM.BCMA Chimeric Antigen Receptor T-cell Injection (C-CAR088) in the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
Trial Summary
This project is a Phase Ib/II clinical trial sponsored by Cellular Biomedicine Group, primarily targeting patients with relapsed/refractory multiple myeloma (RRMM) who have previously received at least 3 lines of anti-myeloma therapy (including at least one proteasome inhibitor and one immunomodulatory agent). The therapeutic regimen utilizes BCMA-targeting chimeric antigen receptor T-cell (CAR-T) therapy injection (C-CAR088), administered via a single intravenous infusion. This study is a domestic clinical trial in China, and according to published information, it is currently primarily conducted at the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology).
Participating Centers0 in China + 1 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
- CTR20221467
- Verify on the NMPA CDE public platformby entering CTR20221467 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 years, ECOG performance status ≤ 1, ≥ 3 prior lines of therapy. The study specifies 10 inclusion and 18 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 [Autologous anti-BCMA 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 Ib/II] 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 1 overseas centres. The lead institution is [Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology)]. Prominent sites include Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology). Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20221467] (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 Ib/II
Target / Therapy
Autologous anti-BCMA CAR-T
Sponsor
Cellular Biomedicine Group (Shanghai) Co., Ltd.
Principal Investigator
Lugui Qiu
Lead Institution
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology)
Participating Centers
0 in China + 1 overseas
CDE Registry ID
CTR20221467
ClinicalTrials.gov ID
NCT05521802Trial 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.
View CAR-T in China Guide →Evidence · Process · Costs · Verified hospitals
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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