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)
Number of patients who experience dose-limiting toxicity (DLT) during the first cycle of treatment - Part 1 as defined in Clinical Study Protocol — Up to Day 21 (from first dose)
Objective response rate (ORR) — Through study completion, an average of 1 year Proportion of enrolled subjects who achieve a partial response (PR) or better, i.e. stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and PR, according to the IMWG criteria.
Trial sites (24)
Facility
City
Region
Status
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.
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.
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