Recombinant humanized anti-CD38 monoclonal ant… · relapsed/refractory multiple myeloma Phase I/II clinical trial
Official protocol title:A Multicenter, Open-Label Phase I/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CM313(SC) Injection as Monotherapy and in Combination with Other Antitumor Therapies in Participants with Relapsed/Refractory Multiple Myeloma (RRMM)
Trial Summary
This study is a Phase I/II clinical trial sponsored by Keymed Biosciences (Chengdu) Co., Ltd., primarily targeting patients with relapsed/refractory multiple myeloma (RRMM) who have received at least 2 prior lines of therapy (including proteasome inhibitors and immunomodulatory drugs) or at least 1 prior line of therapy (including proteasome inhibitors and lenalidomide), and have not previously received anti-CD38 monoclonal antibody therapy. The treatment regimen uses the biologic CM313(SC) injection as monotherapy, or in combination with an immunomodulatory drug (pomalidomide) and a corticosteroid (dexamethasone), administered in 28-day treatment cycles until disease progression or intolerable toxicity. The trial is conducted across a total of 16 leading domestic hospitals in China, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences; The First Affiliated Hospital, Zhejiang University School of Medicine; Peking University Third Hospital; Shanghai Tongji Hospital; and Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Participating Centers1 in China + 15 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
- CTR20233843
- Verify on the NMPA CDE public platformby entering CTR20233843 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 ≤ 2, ≥ 1 prior lines of therapy. The study specifies 10 inclusion and 26 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/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 15 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, The First Affiliated Hospital, Zhejiang University School of Medicine, Shengjing Hospital of China Medical University, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20233843] (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/II
Target / Therapy
Recombinant humanized anti-CD38 monoclonal antibody
Sponsor
Keymed Biosciences (Chengdu) Co., Ltd.
Principal Investigator
Lugui Qiu
Lead Institution
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Participating Centers
1 in China + 15 overseas
CDE Registry ID
CTR20233843
ClinicalTrials.gov ID
NCT04818372Trial 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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