T-cell redirecting bispecific antibody · relapsed/refractory multiple myeloma Phase II clinical trial
Official protocol title:A Multicenter, Open-label Phase II Study Evaluating QLS32015 Combination Therapy in the Treatment of Multiple Myeloma
Trial Summary
This study is a Phase II clinical trial sponsored by Qilu Pharmaceutical Co., Ltd., primarily enrolling participants with multiple myeloma who have relapsed, progressed, or were intolerant after at least 1 prior line of therapy (no specific gene mutation required). The treatment regimen consists of QLS32015 for injection (a T-cell redirecting therapeutic drug) combined with QL2109 injection, administered subcutaneously once every 4 weeks. The trial is conducted at a total of 50 top domestic hospitals in China, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, Peking University Third Hospital, Sun Yat-sen University Cancer Center, The First Hospital of Jilin University, and China-Japan Friendship Hospital.
Participating Centers1 in China + 49 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
- CTR20252454
- Verify on the NMPA CDE public platformby entering CTR20252454 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, ≥ 1 prior lines of therapy. The study specifies 13 inclusion and 15 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 [T-cell redirecting 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 II] 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 1 study centres in China and 49 overseas centres. The lead institution is [Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences]. Prominent sites include Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Nanyang Central Hospital, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20252454] (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 II
Target / Therapy
T-cell redirecting bispecific antibody
Sponsor
Qilu Pharmaceutical Co., Ltd.
Principal Investigator
Gang An
Lead Institution
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Participating Centers
1 in China + 49 overseas
CDE Registry ID
CTR20252454
ClinicalTrials.gov ID
NCT07018050Trial 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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