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

ID#: NCT04879043

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1/Phase 2

Recruitment Status: Recruiting

Start Date: January 01, 2022

End Date: May 01, 2025

Contact Information:
András Strassz, MD
+ 49 6203 1009 0
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.

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.