Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma

Description

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.

Conditions

Multiple Myeloma, Plasma Cell Disorder

Study Overview

Study Details

Study overview

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.

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

Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma

Condition
Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Atlanta

Winship Cancer Institute of Emory University, Atlanta, Georgia, United States, 30322

New York

Mount Sinai, The Tisch Cancer Instutute, New York, New York, United States, 10029

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Heidelberg Pharma AG,

Study Record Dates

2026-05