antibody-drug conjugate · relapsed/refractory multiple myeloma Phase Ib/IIa clinical trial
Official protocol title:A Phase Ib/IIa, Open-Label, Dose-Escalation and Expansion Study Evaluating the Safety and Efficacy of an Anti-CD38 Antibody-Drug Conjugate (STI-6129) in Patients with Relapsed or Refractory Multiple Myeloma
Trial Summary
This project is a Phase Ib/IIa clinical trial sponsored by Zhejiang ACEA Pharmaceutical Co., Ltd., primarily targeting patients with multiple myeloma who have previously received at least three agents (including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody) and have relapsed or refractory disease following their most recent therapy. The treatment regimen utilizes an anti-CD38 antibody-drug conjugate (STI-6129 for Injection) administered via intravenous infusion in 28-day treatment cycles until disease progression or unacceptable toxicity. The trial is being conducted across four leading domestic hospitals in China: The First Affiliated Hospital, Zhejiang University School of Medicine; The First Affiliated Hospital, Sun Yat-sen University; Beijing Chaoyang Hospital, Capital Medical University; and Peking University Third Hospital.
Participating Centers0 in China + 4 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
- CTR20222476
- Verify on the NMPA CDE public platformby entering CTR20222476 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. The study specifies 6 inclusion and 24 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 [antibody-drug conjugate (ADC)]. 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 Ib/IIa] 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 4 overseas centres. The lead institution is [The First Affiliated Hospital, Zhejiang University School of Medicine]. Prominent sites include The First Affiliated Hospital, Zhejiang University School of Medicine, The First Affiliated Hospital, Sun Yat-sen University, Beijing Chaoyang Hospital, Capital Medical University, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20222476] (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 Ib/IIa
Target / Therapy
antibody-drug conjugate (ADC)
Sponsor
Zhejiang ACEA Pharmaceutical Co., Ltd.
Principal Investigator
Jie Jin
Lead Institution
The First Affiliated Hospital, Zhejiang University School of Medicine
Participating Centers
0 in China + 4 overseas
CDE Registry ID
CTR20222476
ClinicalTrials.gov ID
NCT05565807Trial 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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