GPRC5D × CD3-targeting bispecific antibody · relapsed/refractory multiple myeloma Phase I clinical trial
Official protocol title:A Phase I Clinical Trial of QLS32015 for Injection Evaluating Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy in Patients with Relapsed or Refractory Multiple Myeloma
Trial Summary
This project is a Phase I clinical trial sponsored by Qilu Pharmaceutical Co., Ltd., mainly targeting patients with relapsed or refractory multiple myeloma who have progressed on or are intolerant to all available established therapies (Phase Ib targets patients who have received at least 3 prior lines of therapy). The treatment regimen uses the biological product QLS32015 for Injection (an innovative drug involving T-cell redirection or GPRC5D targeting), administered weekly via subcutaneous injection. The trial is conducted at a total of 11 top domestic hematology hospitals in China, including Tianjin Institute of Hematology (Hospital of Blood Diseases, Chinese Academy of Medical Sciences), The First Affiliated Hospital, Zhejiang University School of Medicine, Sichuan Provincial People's Hospital, Henan Cancer Hospital, and The First Hospital of China Medical University.
Participating Centers2 in China + 9 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
- CTR20232373
- Verify on the NMPA CDE public platformby entering CTR20232373 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 years, ECOG performance status ≤ 1, ≥ 3 prior lines of therapy. The study specifies 12 inclusion and 18 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 [GPRC5D × CD3-targeting bispecific 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 2 study centres in China and 9 overseas centres. Prominent sites include Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, Henan Cancer Hospital, Shandong Cancer Hospital affiliated to Shandong First Medical University, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20232373] (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
GPRC5D × CD3-targeting bispecific antibody
Participating Centers
2 in China + 9 overseas
CDE Registry ID
CTR20232373
ClinicalTrials.gov ID
NCT05920876Trial 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