Phase
Condition
Cancer
Bone Neoplasm
Red Blood Cell Disorders
Treatment
HDP-101
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 establishedby 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 haveincluded an immunomodulatory drug, proteasome inhibitor, and anti-CD38 treatment,alone or in combination. In addition, the patient should either refractory orintolerant to any established standard of care therapy providing a meaningfulclinical benefit for the patient assessed by the Investigator.
Measurable disease as per IMWG criteria.
Adequate organ system function as defined in protocol.
Exclusion
Exclusion Criteria:
For patient entering the Phase 2a part only: Prior treatment with any approved orexperimental 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 planningfor autologous SCT.
Symptomatic graft versus host disease post allogenic hemopoietic cell transplantwithin 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 Bcore antigen.
Patients with positive test results for hepatitis C virus (HCV) infection.
Current active liver or biliary disease.
Study Design
Study Description
Connect with a study center
Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie
Berlin, 12203
GermanySite Not Available
Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III
Chemnitz, 09116
GermanyActive - Recruiting
Asklepios Klinik Altona, Haematologie und internistische Onkologie
Hamburg, 22763
GermanyActive - Recruiting
Universitätsklinikum Heidelberg
Heidelberg, 69120
GermanyActive - Recruiting
Universitätsklinikum Schleswig-Holstein
Kiel, 24105
GermanyActive - Recruiting
Universitätsklinikum Köln
Köln, 50937
GermanyActive - Recruiting
UKSH Campus Lübeck Klinik für Hämatologie und Onkologie
Lübeck, 23538
GermanyActive - Recruiting
Universitätsklinikum Mainz
Mainz, 55131
GermanySite Not Available
National Institute of Oncology, Department of Oncological Internal Medicine
Budapest, 1122
HungaryActive - Recruiting
Semmelweis University, Belgyogyaszati es Onkologiai Klinika
Budapest, 1083
HungaryActive - Recruiting
Pratia Onkologia Katowice
Katowice, 40-519
PolandActive - Recruiting
Szpital Wojewodzki w Opolu
Opole, 45-061
PolandSite Not Available
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Łódź, 93-513
PolandSite Not Available
Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
United StatesActive - Recruiting
Mount Sinai, The Tisch Cancer Instutute
New York, New York 10029
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
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