Actively Recruiting
Study to Assess Safety and Efficacy of HDP-101 in Chinese Patients With Relapsed or Refractory Multiple Myeloma
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2026-04-14
15
Participants Needed
5
Research Sites
41 weeks
Total Duration
On this page
Sponsors
H
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Lead Sponsor
H
Heidelberg Pharma AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Assess Safety and Efficacy of HDP-101 in Chinese Patients With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 6518 years
- Life expectancy greater than 12 weeks
- Eastern Cooperative Oncology Group Performance Status of 0 to 2
- Confirmed diagnosis of active multiple myeloma according to International Myeloma Working Group criteria
- Have undergone stem cell transplant or be transplant ineligible
- Prior treatment with immunomodulatory drug, proteasome inhibitor, and anti-CD38 therapy; refractory or intolerant to standard care therapies
- Measurable disease as per IMWG criteria (dose-escalation part allows certain non-secretory or oligo-secretory myeloma patients)
- Adequate organ function as defined in protocol
You will not qualify if you...
- Known central nervous system involvement
- Plasma cell leukemia
- History of congestive heart failure
- Stem cell transplant within 12 weeks before first infusion or planning transplant
- Symptomatic graft versus host disease within 12 months after allogeneic transplant
- Radiotherapy within 21 days before first infusion
- Active other malignancy
- Known HIV infection
- Active infection requiring systemic anti-infective therapy
- Positive hepatitis B or C infection
- Current active liver or biliary disease
- Pregnancy or breastfeeding
- Pneumonia or symptomatic pneumonitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100020
Actively Recruiting
2
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
3
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
4
Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
5
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Not Yet Recruiting
Research Team
J
Jianfei Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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