Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma

Recruiting now · Phase 1/Phase 2

Conditions studied: Multiple Myeloma, Plasma Cell Disorder

In brief

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.

Key facts

Study ID

NCT04879043

Run by

Heidelberg Pharma AG

People needed

78

Starts

2022-02-07

Expected to finish

2028-09-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Pratia Onkologia Katowice — Katowice, Poland (enrolling)
• Pratia Onkologia Kraków — Krakow, Poland (enrolling)
• Semmelweis University, Belgyogyaszati es Onkologiai Klinika — Budapest, Hungary (enrolling)
• Mount Sinai, The Tisch Cancer Instutute — New York, New York, United States (enrolling)
• AIDPORT Sp. zo.o. — Skórzewo, Poland (enrolling)
• MICS Centrum Medyczne Torun — Torun, Poland (enrolling)
• Arensia Clinics SRL — Bucharest, Romania (enrolling)
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States (enrolling)
• UKSH Campus Lübeck Klinik für Hämatologie und Onkologie — Lübeck, Germany
• Universitätsklinikum Mainz — Mainz, Germany
• National Institute of Oncology, Department of Oncological Internal Medicine — Budapest, Hungary
• Pécsi Tudományegyetem Klinikai Központ — Pécs, Hungary
• Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi — Lodz, Poland
• Szpital Wojewodzki w Opolu — Opole, Poland
• Oncology Institute Prof. Dr. Ion Chiricuta I.O.C.N. — Cluj-Napoca, Romania
• Norton Healthcare, Inc. — Louisville, Kentucky, United States
• Nebraska Cancer Institute — Omaha, Nebraska, United States
• Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie — Berlin, Germany
• Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III — Chemnitz, Germany
• Universitätsklinikum Köln — Cologne, Germany
• Asklepios Klinik Altona, Haematologie und internistische Onkologie — Hamburg, Germany
• Universitätsklinikum Heidelberg — Heidelberg, Germany
• Universitätsklinikum Schleswig-Holstein — Kiel, Germany

Full record on ClinicalTrials.gov

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