Autologous BCMA/CD19 dual-targeting CAR-T · relapsed/refractory multiple myeloma Phase I/IIa clinical trial
Official protocol title:A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, and Pharmacokinetic Characteristics of KQ-2003 CAR-T Cells in Patients with Relapsed/Refractory Multiple Myeloma
Trial Summary
This project is a Phase I/IIa clinical trial sponsored by Shanghai Keji Pharmaceutical Technology Co., Ltd., primarily enrolling patients with relapsed/refractory multiple myeloma (RRMM) whose disease progressed after or was refractory to at least 3 prior lines of therapy (must include a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody). The treatment regimen utilizes KQ-2003 autologous chimeric antigen receptor T-cell (CAR-T) injection (a biological product of CAR-T therapy), administered as a single intravenous infusion following lymphodepleting conditioning. The trial is conducted at a total of 10 domestic top-tier hospitals in China, including Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences; Peking University First Hospital; Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; and The First Hospital of China Medical University.
Participating Centers1 in China + 9 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
- CTR20233309
- Verify on the NMPA CDE public platformby entering CTR20233309 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 ≤ 2. The study specifies 9 inclusion and 19 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 BCMA/CD19 dual-targeting 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 I/IIa] 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 1 study centres in China and 9 overseas centres. The lead institution is [Peking Union Medical College Hospital, Chinese Academy of Medical Sciences]. Prominent sites include Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, The First Affiliated Hospital of Nanchang University, Peking University First Hospital, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20233309] (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 I/IIa
Target / Therapy
Autologous BCMA/CD19 dual-targeting CAR-T
Sponsor
Shanghai Keqi Pharmaceutical Technology Co., Ltd.
Principal Investigator
Jian Li
Lead Institution
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Participating Centers
1 in China + 9 overseas
CDE Registry ID
CTR20233309
ClinicalTrials.gov ID
NCT06223646Trial 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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