CAR-T Cell Therapy Shows Promise in Treating Acute Lymphoblastic Leukemia

Strategic Insights -

Researchers from the Chinese Academy of Medical Sciences have conducted a phase I trial investigating the efficacy of autologous CD7 CAR-T cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia (T-ALL). The study, which enrolled 30 patients, demonstrated promising results, with 96% of patients responding to the treatment and 85% achieving complete remission or complete remission with incomplete hematologic recovery by day 30.

Key Takeaways:

  • The study evaluated autologous CD7 CAR-T cells manufactured without pre-selection of healthy T cells in patients with refractory or relapsed T-ALL.
  • Thirty patients (29 children and one adult) were enrolled, with a median of two lines of prior therapy.
  • The treatment showed preliminary activity, with 90% of patients receiving infusions after products were confirmed free of leukemia contamination.
  • Common adverse events within 30 days included grade 3-4 cytopenias, cytokine release syndrome, neurotoxicity, infection, and graft-versus-host disease.
  • At day 30, 96% of patients responded to the treatment, and 85% achieved complete remission or CR with incomplete hematologic recovery.
  • Twelve-month progression-free survival with and without censoring transplantation was 22% and 57%, respectively.
  • The study concluded that autologous CD7 CAR-T therapy without T cell pre-selection is feasible in patients with refractory or relapsed T-ALL.

Statistics:

  • 96% of patients responded to the treatment by day 30.
  • 85% of patients achieved complete remission or CR with incomplete hematologic recovery by day 30.
  • 90% of patients received infusions after products were confirmed free of leukemia contamination.
  • 100% of patients experienced grade 3-4 cytopenias as a common adverse event.
  • 7% of patients experienced grade 3-4 cytokine release syndrome.
  • 4% of patients experienced grade 2 infection and grade 2 graft-versus-host disease.
  • 12-month progression-free survival with and without censoring transplantation was 22% and 57%, respectively.

Sources:

  • Autologous Cd7 Car-t Cells Generated Without T Cell Pre-selection In Pediatric Patients With Relapsed/Refactory T-all: a Phase I Trial. Molecular Therapy, 2025;33(6):2753-2767.
  • Chinese Academy of Medical Sciences, State Key Lab Expt Hematol, Institute of Hematology, Natl Clin Res Ctr Blood Dis, Haihe Lab Cell Ecosyst, Tianjin 300020, People's Republic of China.