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Clinical Trials in the USA / NCT04879043
Recruiting Phase 1/2

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

NCT04879043 · tracked via the Priya Life Science USA tracker
Sponsor
Heidelberg Pharma AG
Phase
Phase 1/2
Started
2022-02-07
Last updated
2026-09-17

Condition(s) studied

Multiple MyelomaPlasma Cell Disorder

Investigational drug(s) / intervention(s)

HDP-101

HDP-101: HDP-101 is available as lyophilized white powder for preparation of infusion.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
Winship Cancer Institute of Emory University Atlanta Georgia Recruiting
Norton Healthcare, Inc. Louisville Kentucky Not Yet Recruiting
Nebraska Cancer Institute Omaha Nebraska Recruiting
Mount Sinai, The Tisch Cancer Instutute New York New York Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie Berlin Germany Withdrawn
Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III Chemnitz Germany Withdrawn
Universitätsklinikum Köln Cologne Germany Withdrawn
Asklepios Klinik Altona, Haematologie und internistische Onkologie Hamburg Germany Withdrawn
Universitätsklinikum Heidelberg Heidelberg Germany Active Not Recruiting
Universitätsklinikum Schleswig-Holstein Kiel Germany Withdrawn
UKSH Campus Lübeck Klinik für Hämatologie und Onkologie Lübeck Germany Active Not Recruiting
Universitätsklinikum Mainz Mainz Germany Withdrawn
Semmelweis University, Belgyogyaszati es Onkologiai Klinika Budapest Hungary Recruiting
National Institute of Oncology, Department of Oncological Internal Medicine Budapest Hungary Withdrawn
Pécsi Tudományegyetem Klinikai Központ Pécs Hungary Not Yet Recruiting
Pratia Onkologia Katowice Katowice Poland Recruiting
Pratia Onkologia Kraków Krakow Poland Recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Lodz Poland Withdrawn
Szpital Wojewodzki w Opolu Opole Poland Withdrawn
AIDPORT Sp. zo.o. Skórzewo Poland Recruiting
MICS Centrum Medyczne Torun Torun Poland Recruiting
Arensia Clinics SRL Bucharest Romania Recruiting
Oncology Institute Prof. Dr. Ion Chiricuta I.O.C.N. Cluj-Napoca Romania Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04879043 on ClinicalTrials.gov ↗ ← All trials in the USA