ASCO 2017 - ALL: 75% in phase 1/2 trial of KTE-C19 achieved MRD-CR

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  • At a maximum tolerated dose of 2×106 CAR T cells/kg, 6 of 8 efficacy-evaluable patients achieved MRD-CR in this phase 1/2 trial of the anti-CD19 CAR T-cell therapy KTE-C19 (axicabtagene ciloleucel).

Why this matters

  • The autologous CAR T-cell therapy showed promise in relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) in the ZUMA-1 trial.
  • ZUMA-3 continues to enroll patients.

Study design

  • Single-group, open-label, multicenter study to determine the therapy's safety and efficacy in patients with R/R ALL (n=11).
  • Primary endpoint: incidence of dose-limiting toxicity.
  • After conditioning with cyclophosphamide+fludarabine, patients received either 1×106 or 2×106 CAR T cells/kg.
  • Funding: Kite Pharma Inc.

Key results

  • Patients had 1-4 prior lines of therapy and high disease burden (...