Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHeidelberg Pharma AG
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HDP-101
Treatment groups
78 Participants
are divided into 1 treatment groupLocations
16Germany
Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie12203, Berlin Germany
Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III09116, Chemnitz Germany
Universitätsklinikum Köln50937, Cologne Germany
Asklepios Klinik Altona, Haematologie und internistische Onkologie22763, Hamburg Germany
Sponsors and collaborators
Heidelberg Pharma AG
Lead sponsor
Source ClinicalTrials.gov