CD19, BCMA dual-target in vivo CAR-T · relapsed/refractory multiple myeloma Phase I clinical trial
Official protocol title:An Early Exploratory Clinical Study on the Safety and Efficacy of KSVCBD Injection in the Treatment of CD19- and/or BCMA-Positive B-Cell Malignancies
Trial Summary
This study is an early exploratory clinical trial evaluating the safety and preliminary efficacy of KSVCBD injection in the treatment of CD19- and/or BCMA-positive B-cell malignancies. The study primarily enrolls eligible, pathologically confirmed participants aged 18 to 75 years with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) or relapsed or refractory multiple myeloma (MM). Enrolled participants will receive a single intravenous infusion of KSVCBD injection and undergo long-term follow-up monitoring for safety and efficacy. Currently, this trial is conducted by the Department of Biotherapy at the Chinese PLA General Hospital (301 Hospital) and enrollment is ongoing.
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
- Study site protocol document (original PDF)
- Official registration number
- Protocol filing (no public registry ID)
- Last reconciled
- 2026-09-21
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 registry 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 ≤ 2, ≥ 3 prior lines of therapy. The study specifies 10 inclusion and 22 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 [CD19, BCMA dual-target in vivo 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 [Chinese PLA General Hospital (301 Hospital)]. Prominent sites include Chinese PLA General Hospital (301 Hospital). Eligible domestic patients can seek screening at the nearest participating centre.
Key Information
Status
Recruiting
Phase
Phase I
Target / Therapy
CD19, BCMA dual-target in vivo CAR-T
Sponsor
Chinese PLA General Hospital (301 Hospital)
Principal Investigator
Weidong Han
Lead Institution
Chinese PLA General Hospital (301 Hospital)
Participating Centers
0 in China + 1 overseas
Trial information is synthesized from the official study protocol filings and reviewed by CMDN. Confirm current status and eligibility with the study team.
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Considering a non-trial option?
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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