Small molecule oral targeted drug / Next-gener… · relapsed/refractory multiple myeloma Phase I clinical trial
Official protocol title:A Phase I Clinical Trial of HRS-3738 in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma and Multiple Myeloma
Trial Summary
This project is a Phase I clinical trial sponsored by Jiangsu Hengrui Pharmaceuticals Co., Ltd., primarily targeting patients with relapsed/refractory non-Hodgkin lymphoma and multiple myeloma. For multiple myeloma patients, prior treatment with at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 monoclonal antibody is required (specific combination therapy cohorts require 1 to 3 prior lines of antitumor therapy containing an immunomodulatory drug). The treatment regimen mainly utilizes the chemical drug HRS-3738 tablets (monotherapy or combination therapy) in 28-day cycles (continuous administration for the first 21 days, followed by 7 days off treatment), with treatment continuing until disease progression or participant withdrawal. This trial is conducted entirely within China across a total of 37 top domestic hospitals, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology), The First Affiliated Hospital, Zhejiang University School of Medicine, Renji Hospital, Shanghai Jiao Tong University School of Medicine, The Second Xiangya Hospital of Central South University, and Nanjing Drum Tower Hospital.
Participating Centers1 in China + 36 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
- CTR20221007
- Verify on the NMPA CDE public platformby entering CTR20221007 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 ≤ 1, 1–3 prior lines of therapy. The study specifies 10 inclusion and 17 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 oral targeted drug / Next-generation EED (embryonic ectoderm development protein) inhibitor]. 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 36 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, Shengjing Hospital of China Medical University, Henan Cancer Hospital, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20221007] (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 oral targeted drug / Next-generation EED (embryonic ectoderm development protein) inhibitor
Sponsor
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Principal Investigator
Jie Jin
Lead Institution
The First Affiliated Hospital, Zhejiang University School of Medicine
Participating Centers
1 in China + 36 overseas
CDE Registry ID
CTR20221007
ClinicalTrials.gov ID
NCT05363800Trial 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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