Small-molecule chemical drug · relapsed/refractory multiple myeloma Phase I clinical trial
Official protocol title:A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HP-001 Capsules in Patients with Relapsed/Refractory Multiple Myeloma and Non-Hodgkin Lymphoma
Trial Summary
This project is a Phase I clinical trial sponsored by Shanghai Chaoyang Pharmaceutical Co., Ltd., primarily targeting patients with relapsed/refractory multiple myeloma and non-Hodgkin lymphoma (aged 18 to 75 years, with measurable disease and an expected survival of at least 3 months). The treatment regimen employs monotherapy with the novel chemical drug HP-001 capsules in 28-day cycles (administered on Days 1 to 14 of each cycle), continuing until disease progression or unacceptable toxicity. The trial is a domestic multicenter study with no international medical centers participating, and is currently conducted across a total of 27 top domestic core hospitals, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology), West China Hospital of Sichuan University, Peking University Third Hospital, Guangdong Provincial People's Hospital, and The First Affiliated Hospital, Zhejiang University School of Medicine.
Participating Centers1 in China + 25 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
- CTR20242943
- Verify on the NMPA CDE public platformby entering CTR20242943 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 18–75 years, ECOG performance status ≤ 2. The study specifies 6 inclusion and 6 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] 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 25 overseas centres. The lead institution is [West China Hospital, Sichuan University]. Prominent sites include West China Hospital, Sichuan University, Henan Cancer Hospital, The First Affiliated Hospital of Nanchang University, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20242943] (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
Small-molecule chemical drug
Sponsor
Shanghai Chaoyang Pharmaceutical Co., Ltd.
Principal Investigator
Ting Niu
Lead Institution
West China Hospital, Sichuan University
Participating Centers
1 in China + 25 overseas
CDE Registry ID
CTR20242943
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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