🏛️ Verified NIH Record • Updated 2026-07-16
Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma (NCT04879043)
🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Heidelberg Pharma AG
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (14 items).
Location: Winship Cancer Institute of Emory University — Atlanta, Georgia
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (24 Sites)
- Winship Cancer Institute of Emory University — Atlanta, Georgia
- Norton Healthcare, Inc. — Louisville, Kentucky
- Nebraska Cancer Institute — Omaha, Nebraska
- Mount Sinai, The Tisch Cancer Instutute — New York, New York
- MD Anderson Cancer Center — Houston, Texas
- Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie — Berlin,
- Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III — Chemnitz,
- Universitätsklinikum Köln — Cologne,
- Asklepios Klinik Altona, Haematologie und internistische Onkologie — Hamburg,
- Universitätsklinikum Heidelberg — Heidelberg,
- Universitätsklinikum Schleswig-Holstein — Kiel,
- UKSH Campus Lübeck Klinik für Hämatologie und Onkologie — Lübeck,
- Universitätsklinikum Mainz — Mainz,
- Semmelweis University, Belgyogyaszati es Onkologiai Klinika — Budapest,
- National Institute of Oncology, Department of Oncological Internal Medicine — Budapest,
- Pécsi Tudományegyetem Klinikai Központ — Pécs,
- Pratia Onkologia Katowice — Katowice,
- Pratia Onkologia Kraków — Krakow,
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi — Lodz,
- Szpital Wojewodzki w Opolu — Opole,
- AIDPORT Sp. zo.o. — Skórzewo,
- MICS Centrum Medyczne Torun — Torun,
- Arensia Clinics SRL — Bucharest,
- Oncology Institute Prof. Dr. Ion Chiricuta I.O.C.N. — Cluj-Napoca,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.