HDP-101 for relapsed or refractory multiple myeloma in Chinese patients
Official title: 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
Run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · NCT07529782 · Data updated 2026-11-12
This trial will try HDP-101 to see if it is safe and can help control relapsed or refractory multiple myeloma in Chinese adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 5 sites (Beijing, Beijing Municipality and 4 other locations) |
| Status | Recruiting |
| Started | March 17, 2026 |
| Main results expected | June 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | April 14, 2026 |
| Trial ID | NCT07529782 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with relapsed or refractory multiple myeloma who have received prior IMiD, proteasome inhibitor, and anti-CD38 therapy, have ECOG 0–2, life expectancy >12 weeks, and adequate organ function are the ideal candidates.
✕Probably not a fit
Patients who are newly diagnosed, who have not received the required prior therapies, who have poor organ function or active uncontrolled infections, or who cannot attend visits at the Chinese study sites are unlikely to benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a two-part Phase 1 study of HDP-101 given as monotherapy in Chinese adults with relapsed or refractory multiple myeloma. The first part uses dose escalation to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) in the Chinese population. Once the MTD/RP2D is determined, a dose-expansion cohort will enroll additional patients to collect preliminary evidence of antitumor activity and further characterize safety. Eligible patients are adults who have received prior immunomodulatory, proteasome inhibitor, and anti-CD38 therapies and have measurable or certain non-secretory disease.
Why it matters
Potential benefit: If successful, HDP-101 could provide a new treatment option for heavily pretreated Chinese patients with relapsed or refractory multiple myeloma.
How similar studies have gone: Other BCMA-targeted and novel myeloma therapies have shown clinical activity in relapsed/refractory disease, but HDP-101's exact construct is relatively novel and clinical evidence is still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China Recruiting -
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China Recruiting -
Qilu Hospital of Shandong University
Jinan, Shandong, China Recruiting -
Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China Recruiting -
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China Not yet recruiting
Study contacts
- Study coordinator: Jianfei Zhao
- Email: zhaojianfei@eastchinapharm.com
- Phone: +8618428347838
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.