Autologous CD19/BCMA dual-targeting CAR-T · relapsed/refractory multiple myeloma Phase I clinical trial
Official protocol title:A Multicenter, Open-Label, Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Antitumor Efficacy of YKST02 in the Treatment of Relapsed/Refractory Multiple Myeloma
Trial Summary
This project is a Phase I clinical trial sponsored by Yikexite (Beijing) Pharmaceutical Technology Development Co., Ltd., primarily targeting patients with relapsed/refractory multiple myeloma (RRMM) who have previously received at least 2 lines of therapy (and prior treatment must have included a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody). The treatment regimen employs an innovative biological product (monoclonal antibody drug), YKST02 for injection. The administration schedule is: once weekly during the first 24 weeks, adjusted to once every 2 weeks for weeks 25 to 36, and adjusted to once every 3 weeks for weeks 37 to 52. The project is currently being conducted at a total of 13 key domestic hematology and oncology hospitals, including Beijing Chaoyang Hospital, Capital Medical University; The First Affiliated Hospital, Zhejiang University School of Medicine; Sun Yat-sen University Cancer Center; Beijing Jishuitan Hospital, Capital Medical University; and Henan Cancer Hospital.
Participating Centers0 in China + 13 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
- CTR20241570
- Verify on the NMPA CDE public platformby entering CTR20241570 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 18–75 years, ECOG performance status ≤ 1, ≥ 2 prior lines of therapy. The study specifies 11 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 CD19/BCMA 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 13 overseas centres. The lead institution is [Beijing Chaoyang Hospital, Capital Medical University]. Prominent sites include Beijing Chaoyang Hospital, Capital Medical University, The First Affiliated Hospital, Zhejiang University School of Medicine, Sun Yat-sen University Cancer Center, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20241570] (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 CD19/BCMA dual-targeting CAR-T
Sponsor
Yikexite (Beijing) Pharmaceutical Technology Development Co., Ltd.
Principal Investigator
Wenming Chen
Lead Institution
Beijing Chaoyang Hospital, Capital Medical University
Participating Centers
0 in China + 13 overseas
CDE Registry ID
CTR20241570
ClinicalTrials.gov ID
NCT06574568Trial 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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