Recombinant fully human monoclonal antibody ta… · newly diagnosed multiple myeloma Phase I clinical trial
Official protocol title:A Randomized, Double-Blind, Parallel-Controlled Phase I Study Comparing the Pharmacokinetic Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC Versus DARZALEX FASPRO Combined with Lenalidomide-Dexamethasone (Rd) in Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma
Trial Summary
This randomized, double-blind Phase I study sponsored by Shanghai Henlius Biotech, Inc. enrolls adults with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation. It compares the pharmacokinetics, safety, tolerability, and immunogenicity of subcutaneous HLX15-SC with DARZALEX FASPRO; both are administered with lenalidomide and dexamethasone (Rd). The study is being conducted at 66 sites in China, including Zhongshan Hospital, Fudan University and Peking University Third Hospital.
Participating Centers3 in China + 63 overseas
Source and Verification
Every fact on this page is derived from the original filing 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
- 2026-09-03
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 monoclonal antibody targeting CD38]. 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 3 study centres in China and 63 overseas centres. Prominent sites include Zhongshan Hospital Affiliated to 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 monoclonal antibody targeting CD38
Sponsor
Shanghai Henlius Biotech, Inc.
Participating Centers
3 in China + 63 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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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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