Recombinant fully human anti-CD38 monoclonal a… · newly diagnosed multiple myeloma Phase I clinical trial
Official protocol title:A Randomized, Double-Blind, Parallel-Controlled Phase I Study Comparing the Pharmacokinetic Profile, Safety, Tolerability, and Immunogenicity of HLX15-SC Versus DARZALEX FASPRO; Combined with Lenalidomide-Dexamethasone (Rd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Ineligible for Transplantation
Trial Summary
This study is a sponsor-initiated Phase I clinical trial conducted by Henlius, primarily targeting adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for stem cell transplantation. The trial aims to compare the pharmacokinetic characteristics and safety of the subcutaneous investigational drug HLX15-SC versus the commercially available comparator (subcutaneous daratumumab, trade name: DARZALEX FASPRO) when combined with lenalidomide and dexamethasone. The study is currently being conducted across more than 60 authoritative participating centers nationwide, including Zhongshan Hospital, Fudan University and Peking University Third Hospital.
Participating Centers2 in China + 64 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
- CTR20260785
- Verify on the NMPA CDE public platformby entering CTR20260785 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
- 2026-09-21
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 [Newly diagnosed]. 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, newly diagnosed patients (NDMM). The study specifies 10 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 fully human 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 2 study centres in China and 64 overseas centres. The lead institution is [Zhongshan Hospital, Fudan University]. Prominent sites include Zhongshan Hospital, Fudan University, Peking University Third Hospital, Guangzhou First People's Hospital, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20260785] (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 fully human anti-CD38 monoclonal antibody
Sponsor
Shanghai Henlius Biotech, Inc.
Principal Investigator
Peng Liu
Lead Institution
Zhongshan Hospital, Fudan University
Participating Centers
2 in China + 64 overseas
CDE Registry ID
CTR20260785
ClinicalTrials.gov ID
NCT07477587Trial 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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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.
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