Bispecific antibody targeting GPRC5D×CD3 · relapsed/refractory multiple myeloma Phase I clinical trial
Official protocol title:A Phase I Clinical Study Evaluating the Tolerability and Pharmacokinetics of TQB2029 for Injection in Participants with Multiple Myeloma
Trial Summary
This project is a Phase I clinical trial sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., primarily targeting patients with relapsed/refractory multiple myeloma (RRMM) who have received at least 3 prior lines of therapy (and must be refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-CD38 monoclonal antibody). The treatment regimen employs an innovative biological product (monoclonal antibody drug), TQB2029 for injection, administered in 28-day cycles with injection once weekly or once every 2 weeks, with continuous treatment until disease progression or intolerable toxicity. This project is currently conducted at a total of 12 leading core domestic hospitals in China, including West China Hospital of Sichuan University, Zhongshan Hospital of Fudan University, Jiangsu Province Hospital, Sun Yat-sen University Cancer Center, and Beijing Chaoyang Hospital.
Participating Centers0 in China + 12 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
- CTR20244043
- Verify on the NMPA CDE public platformby entering CTR20244043 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, ≥ 3 prior lines of therapy. The study specifies 10 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 [Bispecific antibody targeting GPRC5D×CD3]. 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 12 overseas centres. The lead institution is [West China Hospital, Sichuan University]. Prominent sites include West China Hospital, Sichuan University, Zhongshan Hospital, Fudan University, Jiangsu Province Hospital, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20244043] (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
Bispecific antibody targeting GPRC5D×CD3
Sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Principal Investigator
Ting Niu
Lead Institution
West China Hospital, Sichuan University
Participating Centers
0 in China + 12 overseas
CDE Registry ID
CTR20244043
ClinicalTrials.gov ID
NCT06700395Trial 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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