Small-molecule chemical drug · relapsed/refractory multiple myeloma Phase I/II clinical trial
Official protocol title:A Phase I/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HP-001 Capsules Combined with Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma
Trial Summary
This project is a Phase I/II clinical trial sponsored by Shanghai Chaoyang Pharmaceutical, primarily targeting patients with relapsed/refractory multiple myeloma (RRMM) who have previously received at least 3 lines of prior therapy. The treatment regimen consists of a novel chemical drug (HP-001 capsules) in combination with a glucocorticoid (dexamethasone tablets) administered in 28-day cycles (HP-001 administered on Days 1–14 of each cycle, and dexamethasone administered on Days 1, 8, 15, and 22 of each cycle), continuing until disease progression or intolerable toxicity. The trial is currently being conducted across a total of 20 leading domestic hospitals in China, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Blood Disease Hospital), West China Hospital of Sichuan University, The First Affiliated Hospital, Zhejiang University School of Medicine, Sun Yat-sen University Cancer Center, and Peking University Third Hospital.
Participating Centers0 in China + 20 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
- CTR20254042
- Verify on the NMPA CDE public platformby entering CTR20254042 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 years, ECOG performance status ≤ 2, ≥ 3 prior lines of therapy. The study specifies 8 inclusion and 16 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 [Small-molecule chemical drug]. 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 0 study centres in China and 20 overseas centres. The lead institution is [West China Hospital, Sichuan University]. Prominent sites include West China Hospital, Sichuan University, Henan Cancer Hospital, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20254042] (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
Small-molecule chemical drug
Sponsor
Shanghai Chaoyang Pharmaceutical Co., Ltd.
Principal Investigator
Ting Niu
Lead Institution
West China Hospital, Sichuan University
Participating Centers
0 in China + 20 overseas
CDE Registry ID
CTR20254042
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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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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