Study on Donor-Derived Anti-CD33 CAR T Cell Therapy for Patients with Relapsed or Resistant Acute Myeloid Leukemia After Stem Cell Transplant

Sponsor: Vor Biopharma

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05984199

Provider View

This clinical trial is testing a new treatment using donor-derived CAR T cells to target and attack leukemia cells in patients with Acute Myeloid Leukemia (AML) that has returned or not responded to treatment after a stem cell transplant.

Patient Parameters

Program Overview

This study is exploring a new treatment called VCAR33, which uses CAR T cells derived from a donor to target CD33, a marker found on most leukemia cells. The trial aims to determine if this approach is safe and effective for patients with Acute Myeloid Leukemia (AML) that has come back or is resistant to treatment after a stem cell transplant. The study will involve about 24 patients and will test different doses to find the safest and most effective amount of VCAR33.

Description

The trial focuses on a new therapy called VCAR33, which uses CAR T cells from a donor to target CD33, a protein found on most leukemia cells. This approach is being tested because CD33 is a common target in leukemia treatments and has shown promise in previous studies. The goal is to see if VCAR33 can help patients with AML that has returned or not responded to treatment after a stem cell transplant. The study will include about 24 patients, divided into two groups based on their disease status. Researchers will test different doses to find the safest and most effective amount of VCAR33. The treatment is expected to work better because it uses healthy donor cells, which may function better than the patient's own cells that have been weakened by previous treatments.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older.
  • Have Acute Myeloid Leukemia (AML) that has returned or is resistant after a stem cell transplant.
  • Received a stem cell transplant from a fully matched donor.
  • Have a certain level of leukemia cells in the bone marrow.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate heart, lung, liver, and kidney function as determined by specific medical tests.
  • The original stem cell donor must be available and willing to donate cells again.

Exclusion Criteria

  • Have had more than one stem cell transplant.
  • Received a transplant from a mismatched or partially matched donor, or from umbilical cord blood.
  • Are less than 100 days post-transplant at the time of treatment.
  • Have had severe graft-versus-host disease (GVHD) unless approved by the study team.
  • Have active GVHD requiring systemic treatment.
  • Have active disease in the central nervous system.
  • Have received certain treatments recently, such as donor lymphocyte infusion or other CAR T cell therapies.
  • Have active or uncontrolled infections.
  • Have a history of HIV or active hepatitis B or C infections.
  • Have had another type of cancer unless disease-free for at least 3 years.
  • Are pregnant or breastfeeding.

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