Recombinant humanized anti-CD38 monoclonal ant… · relapsed/refractory multiple myeloma Phase III clinical trial
Official protocol title:A Randomized, Controlled, Double-Blind, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of SG301 Injection Combined with Pomalidomide and Dexamethasone versus Placebo Combined with Pomalidomide and Dexamethasone in the Treatment of Relapsed/Refractory Multiple Myeloma (Stage 1)
Trial Summary
This project is a Phase III (Stage 1) clinical trial sponsored by Hangzhou SJ Biosciences Co., Ltd., primarily enrolling patients with relapsed/refractory multiple myeloma (RRMM) who have received at least 1 prior line of therapy, have not previously received pomalidomide, and were not refractory to prior anti-CD38 antibody therapy. The treatment regimen comprises an anti-CD38 monoclonal antibody (SG301 injection) in combination with an immunomodulatory drug (pomalidomide) and a glucocorticoid (dexamethasone), administered in 28-day cycles, with study treatment continuing until disease progression or unacceptable toxicity. The trial is conducted at a total of 12 top domestic hospitals in China, including The First Affiliated Hospital of Soochow University, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Tianjin Medical University Cancer Institute and Hospital, and The Second Affiliated Hospital, Zhejiang University School of Medicine.
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
- CTR20241042
- Verify on the NMPA CDE public platformby entering CTR20241042 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 10 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 [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 III] 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 [The First Affiliated Hospital of Soochow University]. Prominent sites include The First Affiliated Hospital of Soochow University, Beijing Chaoyang Hospital, Capital Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20241042] (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 III
Target / Therapy
Recombinant humanized anti-CD38 monoclonal antibody
Sponsor
Hangzhou SJ Biosciences Co., Ltd.
Principal Investigator
Depei Wu
Lead Institution
The First Affiliated Hospital of Soochow University
Participating Centers
0 in China + 12 overseas
CDE Registry ID
CTR20241042
ClinicalTrials.gov ID
NCT06508983Trial 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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