Small molecule targeted drug · relapsed/refractory multiple myeloma Phase I clinical trial
Official protocol title:A Multicenter, Open-Label Phase I Clinical Study Evaluating the Safety, Pharmacokinetics, and Efficacy of HMPL-506 in Hematologic Malignancies
Trial Summary
This project is a phase I clinical trial sponsored by Hutchison MediPharma (Shanghai) Limited, primarily targeting adult patients with hematologic malignancies that have relapsed or become refractory after prior therapies. Eligible participants must meet specific genetic characteristics: such as relapsed/refractory acute myeloid or lymphoblastic leukemia (AML/ALL) with MLL rearrangement and/or NPM1 mutation, AML with NUP214 or NUP98 fusion; or relapsed/refractory multiple myeloma (RRMM) (no biomarker screening required). The treatment regimen uses the novel small molecule chemical targeted agent (inferred to be a Menin inhibitor based on exclusion criteria) HMPL-506 tablets orally as monotherapy, administered using a lead-in dose followed by therapeutic dosing, with 28 days per cycle, continuing until disease progression or intolerable toxicity. This trial is conducted across 14 top domestic hospitals in China, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Blood Diseases Institute), Nanfang Hospital of Southern Medical University, Qilu Hospital of Shandong University, The First Affiliated Hospital, Zhejiang University School of Medicine, and The First Affiliated Hospital of Soochow University.
Participating Centers1 in China + 12 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
- CTR20241210
- Verify on the NMPA CDE public platformby entering CTR20241210 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 [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 7 inclusion and 23 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 targeted 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 12 overseas centres. The lead institution is [Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences]. Prominent sites include Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, Nanfang Hospital of Southern Medical University, Qilu Hospital of Shandong University, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20241210] (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 targeted drug
Sponsor
Hutchison MediPharma (Shanghai) Limited
Principal Investigator
Jianxiang Wang
Lead Institution
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Participating Centers
1 in China + 12 overseas
CDE Registry ID
CTR20241210
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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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.
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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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