In situ CAR-T cell therapy targeting multiple… · relapsed/refractory multiple myeloma Phase I clinical trial
Official protocol title:A Phase I Study of In Vivo CAR-T Therapy for Advanced Malignant Tumors (Multiple Myeloma, Lymphoma, Leukemia, Solid Tumors)
Trial Summary
This Phase I study sponsored by Shenzhen Pregene Biopharma Co., Ltd. enrolls patients with advanced malignancies, including relapsed/refractory multiple myeloma, whose standard treatment has failed. Participants receive a single intravenous infusion of investigational V001, an in vivo CAR-T approach designed to generate CAR-T cells in the body; the protocol describes administration without ex vivo cell manufacturing or lymphodepleting conditioning. Led by Cancer Hospital, Chinese Academy of Medical Sciences, the study is intended to evaluate safety, tolerability, and preliminary antitumor activity. Clinical benefit has not been established.
Participating Centers0 in China + 1 overseas
Source and Verification
Every fact on this page is derived from the original filing below. The source document is archived as a PDF for direct verification.
- Document type
- Study document (original PDF)
- Official registration number
- No CDE registration number
- Last reconciled
- 2026-09-03
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 years, ECOG performance status ≤ 2. The study specifies 14 inclusion and 8 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 [In situ (in vivo) CAR-T cell therapy targeting multiple targets including BCMA/GPRC5D/DLL3/FcRH5]. 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 [Cancer Hospital, Chinese Academy of Medical Sciences]. Prominent sites include Cancer Hospital, Chinese Academy of Medical Sciences. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [TM20260016] (OTHER). Patients and researchers can verify registration and ethical authorizations directly through the study hospital ethics committee or designated registry.
Key Information
Status
Recruiting
Phase
Phase I
Target / Therapy
In situ (in vivo) CAR-T cell therapy targeting multiple targets including BCMA/GPRC5D/DLL3/FcRH5
Sponsor
Shenzhen Pregene Biopharma Co., Ltd.
Lead Institution
Cancer Hospital, Chinese Academy of Medical Sciences
Participating Centers
0 in China + 1 overseas
Study ID
TM20260016
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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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.
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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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