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Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
RecruitingPhase 1, Phase 2
Sponsor: Heidelberg Pharma AG
Conditions: Multiple Myeloma, Plasma Cell Disorder
Interventions: HDP-101
Countries: United States, Germany, Hungary, Poland, Romania
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.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility 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. * Adequate organ system function as defined in protocol. Exclusion Criteria: * 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. * Known human immunodeficiency virus infection. * Patients with active infection requiring systemic anti-infective. * Patients with positive test results for hepatitis B surface antigen or Hepatitis B core antigen. * Patients with positive test results for hepatitis C virus (HCV) infection. * Current active liver or biliary disease.
Locations (24)
- Atlanta, Georgia, United States
- Louisville, Kentucky, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Houston, Texas, United States
- Berlin, Germany
- Chemnitz, Germany
- Cologne, Germany
- Hamburg, Germany
- Heidelberg, Germany
- Kiel, Germany
- Lübeck, Germany
- Mainz, Germany
- Budapest, Hungary
- Budapest, Hungary
- Pécs, Hungary
- Katowice, Poland
- Krakow, Poland
- Lodz, Poland
- Opole, Poland
- Skórzewo, Poland
- Torun, Poland
- Bucharest, Romania
- Cluj-Napoca, Romania