Autologous BCMA/CD19 dual-targeting CAR-T · relapsed/refractory multiple myeloma Phase I clinical trial
Official protocol title:A Clinical Study of the Safety, Tolerability, and Preliminary Efficacy of SWK001 in Patients with Relapsed or Refractory Multiple Myeloma
Trial Summary
This project is a Phase I clinical trial sponsored by Hunan Siweikang Pharmaceutical Co., Ltd., mainly targeting patients with relapsed or refractory multiple myeloma who have received at least 3 prior lines of therapy (which must include at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 antibody). The treatment regimen employs a safety-engineered chimeric antigen receptor T-cell (CAR-T) injection targeting BCMA-CD19 (SWK001), administered via a single intravenous infusion. This trial is a domestic clinical study. According to currently disclosed information, it is being conducted at 1 site in China, The First Affiliated Hospital of USTC, with no other domestic top hematology hospitals or international medical centers participating at present.
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
- CTR20240189
- Verify on the NMPA CDE public platformby entering CTR20240189 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, ≥ 3 prior lines of therapy. The study specifies 15 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 [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] 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 [The First Affiliated Hospital of USTC]. Prominent sites include The First Affiliated Hospital of USTC. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20240189] (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
Target / Therapy
Autologous BCMA/CD19 dual-targeting CAR-T
Sponsor
Hunan Siweikang Pharmaceutical Co., Ltd.
Principal Investigator
Xingbing Wang
Lead Institution
The First Affiliated Hospital of USTC
Participating Centers
0 in China + 1 overseas
CDE Registry ID
CTR20240189
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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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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