Recombinant humanized anti-CD38 monoclonal ant… · relapsed/refractory multiple myeloma Phase I clinical trial
Official protocol title:A Phase I Clinical Trial Evaluating the Tolerability and Pharmacokinetics of TQB2934 for Injection in Participants with Multiple Myeloma
Trial Summary
This project is a Phase I clinical trial sponsored by Chia Tai Tianqing Pharmaceutical Group, mainly targeting patients with relapsed/refractory multiple myeloma (RRMM) who have received at least 1 prior line of therapy and are refractory to at least 1 proteasome inhibitor (PI), 1 immunomodulatory drug (IMiD), and 1 anti-CD38 monoclonal antibody (excluding patients who have previously received BCMA-targeted therapy or chimeric antigen receptor T-cell (CAR-T) therapy). The treatment regimen uses a novel biological product (TQB2934 for injection) in 28-day cycles, administered once weekly for the first 3 cycles, and subsequently adjusted to once every 2 weeks or once every 4 weeks based on efficacy, continuing for up to 2 years or until disease progression. The trial is conducted at a total of 14 leading domestic hospitals in China, including Peking Union Medical College Hospital, Zhongshan Hospital of Fudan University, Sun Yat-sen University Cancer Center, Tianjin Medical University Cancer Institute and Hospital, and Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Participating Centers0 in China + 14 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
- CTR20223310
- Verify on the NMPA CDE public platformby entering CTR20223310 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 ≤ 2, ≥ 1 prior lines of therapy. The study specifies 8 inclusion and 5 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 [Recombinant humanized anti-CD38 monoclonal antibody]. 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 14 overseas centres. The lead institution is [Zhongshan Hospital, Fudan University]. Prominent sites include Zhongshan Hospital, Fudan University, Sun Yat-sen University Cancer Center, Peking Union Medical College Hospital, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20223310] (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
Recombinant humanized anti-CD38 monoclonal antibody
Sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Principal Investigator
Peng Liu
Lead Institution
Zhongshan Hospital, Fudan University
Participating Centers
0 in China + 14 overseas
CDE Registry ID
CTR20223310
ClinicalTrials.gov ID
NCT07179679Trial information is translated from the Chinese source record and reviewed by CMDN. Confirm current status and eligibility with the study team.
Where this study sits in the landscape
Browse comparable active studies by disease stage, modality and province
Keywords
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.
Read application guide & patient rights