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Universal Base-Edited CAR7 T Cells for T-Cell Acute Lymphoblastic Leukemia.

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The New England Journal of Medicine
|December 9, 2025
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Base-edited anti-CD7 CAR T cells (BE-CAR7) show promise in treating relapsed or refractory T-cell acute lymphoblastic leukemia (ALL). Most patients achieved remission, enabling successful stem cell transplants and long-term disease control.

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Area of Science:

  • Oncology
  • Immunotherapy
  • Hematology

Background:

  • CD7 is a key target for CAR T-cell therapy in T-cell acute lymphoblastic leukemia (ALL).
  • Previous studies showed supportive results for base-edited anti-CD7 CAR (BE-CAR7) T cells.
  • BE-CAR7 T cells utilize triple C→T deamination for TCRαβ, CD52, and CD7 knockouts.

Purpose of the Study:

  • To evaluate the safety and efficacy of BE-CAR7 T cells in pediatric and adult patients with relapsed or refractory T-cell ALL.
  • To assess the rate of complete remission and the feasibility of proceeding to allogeneic hematopoietic stem-cell transplantation.
  • To determine secondary outcomes including remission duration, disease-free survival, and overall survival.

Main Methods:

  • A phase 1 study administered BE-CAR7 T cells to children (≤16 years) and adults with relapsed/refractory T-cell ALL.
  • Patients received lymphodepletion with fludarabine, cyclophosphamide, and alemtuzumab prior to BE-CAR7 T-cell infusion.
  • Patients achieving remission by day 28 proceeded to allogeneic hematopoietic stem-cell transplantation.

Main Results:

  • BE-CAR7 T cells were administered to 11 patients (9 children, 2 adults).
  • No unacceptable adverse events were observed during lymphodepletion and BE-CAR7 infusions; circulating CAR7 T cells were detected in all patients.
  • 82% of patients achieved deep remission, allowing them to proceed to stem-cell transplantation; 64% remained in remission at 3-36 months post-transplant.
  • Leukemia with loss of CD7 expression occurred in 2 patients; viral reactivations were frequent post-transplantation.

Conclusions:

  • Universal BE-CAR7 T cells induced leukemic remission in most patients with relapsed/refractory T-cell ALL.
  • BE-CAR7 T-cell therapy facilitated successful allogeneic hematopoietic stem-cell transplantation in the majority of treated patients.
  • BE-CAR7 T cells represent a promising therapeutic strategy for T-cell ALL, warranting further investigation.