Clinical Trials in Poland / 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 Poland tracker
Condition(s) studied
Multiple MyelomaPlasma Cell Disorder
Investigational drug(s) / intervention(s)
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
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. | 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 Poland