RecruitingMultiple MyelomaPlasma Cell Disorder
Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
Eligible age
18+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
See if you qualify for this study
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About this study
This study will assess the safety, tolerability, pharmacokinetics (PK) and the therapeutic potential of HDP-101 in patients with plasma cell disorders including multiple myeloma.
Sponsor: Heidelberg Pharma AG
You may qualify if…
- ✓ 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.
- ✓ Adequate organ system function as defined in protocol.
You may not qualify if…
- ✕ For patient entering the Phase 2a part only: Prior treatment with any approved or experimental BCMA-targeting modalities are not allowed.
- ✕ 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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT04879043 · last updated 2026-09-17