In vivo chimeric antigen receptor T-cell ther… · relapsed/refractory multiple myeloma Phase I clinical trial
Official protocol title:A Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of CR-2011 in Relapsed/Refractory Multiple Myeloma
Trial Summary
This is an investigator-initiated trial (IIT) primarily designed for patients with relapsed or refractory multiple myeloma who have received at least 3 prior lines of therapy. Eligible participants will receive intravenous infusions of the innovative CR-2011 therapy, which directly generates BCMA-targeted CAR-T cells in vivo to eliminate tumors, administered for a planned total of 3 doses. Currently, patient enrollment is ongoing at 1 participating center (renowned domestic oncology hospital), including the Cancer Hospital Chinese Academy of Medical Sciences.
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 site protocol 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 ≤ 1. The study specifies 11 inclusion and 21 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 vivo chimeric antigen receptor T-cell (CAR-T) therapy targeting BCMA (based on mRNA-LNP technology)]. 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.
Key Information
Status
Recruiting
Phase
Phase I
Target / Therapy
In vivo chimeric antigen receptor T-cell (CAR-T) therapy targeting BCMA (based on mRNA-LNP technology)
Sponsor
Shanghai Zhenyu Biotechnology
Principal Investigator
Ning Li
Lead Institution
Cancer Hospital Chinese Academy of Medical Sciences
Participating Centers
0 in China + 1 overseas
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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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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