B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells With Fludarabine and Cyclophosphamide Lymphodepletion for the Treatment of Relapsed or Refractory B-cell Hematologic Malignancies

This phase I trial tests safety, side effects and best dose of B-cell activating factor receptor (BAFFR)-based chimeric antigen receptor T-cells, with fludarabine and cyclophosphamide lymphodepletion, for the treatment of patients with B-cell hematologic malignancies that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). BAFFR-based chimeric antigen receptor T-cells is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a pa

Trial Details

NCT ID
NCT06191887
Phase
PHASE1
Sponsor
Mayo Clinic
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Autologous BAFFR-targeting CAR T Cells
  • Bendamustine
  • Biopsy
  • Biospecimen Collection
  • Bone Marrow Aspiration and Biopsy
  • Computed Tomography
Locations (sample)
  • Jacksonville, Florida, United States|30.33218,-81.65565

Key Eligibility Criteria

  • PRE-REGISTRATION: Age ≥ 18 years
  • PRE-REGISTRATION: Confirmed diagnosis of 1 of the following relapsed or refractory B-cell hematologic malignancies: chronic lymphocytic leukemia/sm…
  • For CD19+ B cell malignancies; relapsed or refractory disease is defined by one of the following histopathology:
  • Biopsy proven SLL or flow cytometry proven CLL; relapsed or refractory disease is defined as:

For full eligibility, visit ClinicalTrials.gov.

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