Recombinant humanized anti-CD38 monoclonal ant… · relapsed/refractory multiple myeloma Phase I clinical trial
Official protocol title:A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of KYS202002A Monoclonal Antibody Injection in Patients with Relapsed or Refractory Multiple Myeloma
Trial Summary
This project is a Phase I clinical trial jointly sponsored by Jiangsu Kanion Pharmaceutical Co., Ltd. and Zhixiang Biotech (Suzhou) Co., Ltd., primarily enrolling participants with relapsed or refractory multiple myeloma (RRMM) who have failed adequate treatment with at least two prior lines of standard therapy (including prior exposure to proteasome inhibitors and immunomodulatory drugs). The treatment regimen employs a monoclonal antibody (KYS202002A injection) administered via intravenous infusion in 28-day cycles across different dosing phases (gradually extended from once weekly to once every 4 weeks), with treatment continuing until disease progression. The trial is conducted across a total of 7 participating centers in China, including Beijing Chaoyang Hospital of Capital Medical University, Zhongshan Hospital of Fudan University, Sun Yat-sen University Cancer Center, Tianjin Medical University Cancer Institute and Hospital, and Shandong Provincial Hospital.
Participating Centers1 in China + 6 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
- CTR20230879
- Verify on the NMPA CDE public platformby entering CTR20230879 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
- 2026-09-04
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 ≤ 1, ≥ 2 prior lines of therapy. The study specifies 9 inclusion and 20 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 1 study centres in China and 6 overseas centres. The lead institution is [Beijing Chaoyang Hospital, Capital Medical University]. Prominent sites include Beijing Chaoyang Hospital, Capital Medical University, Shengjing Hospital of China Medical University, Zhongshan Hospital, Fudan University, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20230879] (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
Jiangsu Kanion Pharmaceutical Co., Ltd.
Principal Investigator
Wenming Chen
Lead Institution
Beijing Chaoyang Hospital, Capital Medical University
Participating Centers
1 in China + 6 overseas
CDE Registry ID
CTR20230879
Trial 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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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.
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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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