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Clinical Trials in China / NCT07529782
Recruiting Phase 1

Study to Assess Safety and Efficacy of HDP-101 in Chinese Patients With Relapsed or Refractory Multiple Myeloma

NCT07529782 · tracked via the Priya Life Science China tracker
Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Phase
Phase 1
Started
2026-03-17
Last updated
2026-04-14

Condition(s) studied

Multiple Myeloma and Other Plasma Cell Neoplasms

Investigational drug(s) / intervention(s)

HDP-101

HDP-101: HDP-101 is available as lyophilized white powder for preparation of infusion.

Study summary

This study is a 2-part study with a dose-escalation part and a dose-expansion part. The aim of the dose-escalation part is to determine the maximum tolerated dose (MTD) and/or establish the recommended Phase 2 dose (RP2D) in the Chinese population, in order to select the treatment dose for the dose-expansion part. The dose-escalation part will be followed by the dose-expansion part once the MTD(s) and/or RP2D of HDP-101 monotherapy in the Chinese population have been determined. The dose-expansion part of the study is intended to collect preliminary evidence of antitumor activity and to confirm the safety of the HDP-101 as monotherapy in Chinese patients with r/r MM.

Eligibility

Sex
ALL
Min age
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Male or female aged ≥18 years. * Life expectancy \>12 weeks. * Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2. * A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG). * Must have undergone SCT or is considered transplant ineligible. * Must have undergone prior treatments with antimyeloma therapy which must have included an immunomodulatory drug, proteasome inhibitor, and anti-CD38 treatment, alone or in combination. In addition, the patient should either refractory or intolerant to any established standard of care therapy providing a meaningful clinical benefit for the patient assessed by the Investigator. * Measurable disease as per IMWG criteria (Dose-escalation part only: patients with non-secretory or oligo-secretory myeloma (NSMM) not meeting the measurability criteria are eligible). * Adequate organ system function as defined in protocol. Exclusion Criteria: * Known central nervous system involvement. * Plasma cell leukemia. * History of congestive heart failure. * Autologous or allogenic SCT within 12 weeks before the first infusion or is planning for autologous SCT. * Symptomatic graft versus host disease post allogenic hemopoietic cell transplant within 12 months prior to the first study treatment infusion. * Radiotherapy within 21 days prior to the first study treatment infusion. * History of any other malignancy known to be active. * Known human immunodeficiency virus infection. * Patients with active infection requiring systemic anti-infective therapy. * Patients with positive hepatitis B virus (HBV) infection or positive hepatitis C virus (HCV) infection. * Current active liver or biliary disease. * Pregnancy or breast feeding. * Pneumonia or symptomatic pneumonitis.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Beijing Chao-Yang Hospital, Capital Medical University Beijing Beijing Municipality Recruiting
The First Affiliated Hospital of Soochow University Suzhou Jiangsu Recruiting
Qilu Hospital of Shandong University Jinan Shandong Recruiting
Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences Tianjin Tianjin Municipality Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Not Yet Recruiting

More Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07529782 on ClinicalTrials.gov ↗ ← All trials in China