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Official Title

A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients With Plasma Cell Disorders Including Multiple Myeloma

Phase
Phase 1/Phase 2
Sponsor
Heidelberg Pharma AG
Enrollment
78
Timeline
Feb 2022 → May 2026
About This Study

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

Inclusion Criteria

  • 1Male or female aged ≥18 years.
  • 2Life expectancy \>12 weeks.
  • 3Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2.
  • 4A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG).
  • 5Must have undergone SCT or is considered transplant ineligible.
  • 6Must 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.
  • 7Measurable disease as per IMWG criteria.
  • 8Adequate organ system function as defined in protocol.

Exclusion Criteria

  • 1For patient entering the Phase 2a part only: Prior treatment with any approved or experimental BCMA-targeting modalities are not allowed.
  • 2Known central nervous system involvement.
  • 3Plasma cell leukemia.
  • 4History of congestive heart failure.
  • 5Autologous or allogenic SCT within 12 weeks before the first infusion or is planning for autologous SCT.
  • 6Symptomatic graft versus host disease post allogenic hemopoietic cell transplant within 12 months prior to the first study treatment infusion.
  • 7Radiotherapy within 21 days prior to the first study treatment infusion.
  • 8History of any other malignancy known to be active.
  • 9Known human immunodeficiency virus infection.
  • 10Patients with active infection requiring systemic anti-infective.
  • 11Patients with positive test results for hepatitis B surface antigen or Hepatitis B core antigen.
  • 12Patients with positive test results for hepatitis C virus (HCV) infection.
  • 13Current active liver or biliary disease.

Locations

16 sites participating in this study

Winship Cancer Institute of Emory University

Atlanta, Georgia 30322

Recruiting

Mount Sinai, The Tisch Cancer Instutute

New York, New York 10029

Recruiting

MD Anderson Cancer Center

Houston, Texas 77030

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →