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

April 13, 2026 updated by: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Chinese Patients With Plasma Cell Disorders Including Multiple Myeloma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100020
        • Recruiting
        • Beijing Chao-Yang Hospital, Capital Medical University
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • the First Affiliated Hospital of Soochow University
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • Recruiting
        • Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Not yet recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HDP-101

Participants will receive HDP-101 intravenously in a 21 day cycle until disease progression, intolerable toxicity, Investigator's discretion or patient withdrawal.

During the part 1 tolerability of two or three different dose levels will be evaluated. During the part 2 dose expansion part the recommended phase 2 dose (RP2D) of HDP-101 will be administered.
Drug: HDP-101
HDP-101 is available as lyophilized white powder for preparation of infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients who experience a dose-limiting toxicity (DLT) during the first cycle of treatment.
Time Frame: Up to Day 21 (from first dose)
Up to Day 21 (from first dose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Through study completion, an average of 1 year
Proportion of enrolled subjects who achieve a partial response (PR) or better, i.e. stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and PR, according to the IMWG criteria.
Through study completion, an average of 1 year
Number of patients with serious and non-serious adverse events
Time Frame: Through study completion, an average of 1 year
Incidence and grading of adverse events (AEs) and serious adverse events (SAEs) (based on the National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE] version 5.0). Incidence of treatment interruption and dose adjustment due to AEs and changes in laboratory tests, vital signs, physical examination and electrocardiogram (ECG).
Through study completion, an average of 1 year
Minimal residual disease (MRD) negativity rate
Time Frame: Through study completion, an average of 1 year
Proportion of enrolled subjects who achieve minimal residual disease (MRD) free status, according to the IMWG criteria.
Through study completion, an average of 1 year
Progression-free survival (PFS)
Time Frame: Through study completion, an average of 1 year
PFS is defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression/relapse or death from any cause, whichever occurs first as determined by the investigator
Through study completion, an average of 1 year
Duration of response (DOR)
Time Frame: Through study completion, an average of 1 year
DOR is defined as the interval from the first documentation of PR or better until disease progression or death due to any cause, whichever occurs first
Through study completion, an average of 1 year
Time to objective response (TOR)
Time Frame: Through study completion, an average of 1 year
TOR is defined as the interval from the start of study therapy to the first documentation of PR or better
Through study completion, an average of 1 year
Overall survival (OS)
Time Frame: Through study completion, an average of 1 year
OS is defined as the time from randomization to death due to any cause
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Collaborators

Heidelberg Pharma AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDP-101-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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