Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)

This is a first-in-human, open-label, dose escalation and expansion study of UCART22 administered intravenously to patients with relapsed or refractory B-cell acute Lymphoblastic Leukemia (B-ALL). The purpose of this study is to evaluate the safety and clinical activity of UCART22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

Trial Details

NCT ID
NCT04150497
Phase
PHASE1 / PHASE2
Sponsor
Cellectis S.A.
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • UCART22
  • CLLS52
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Denver, Colorado, United States|39.73915,-104.9847
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • B-ALL blast cells expressing CD22
  • Diagnosed with R/R B-ALL
  • Prior therapy must include at least one standard chemotherapy regimen and at least one salvage regimen

For full eligibility, visit ClinicalTrials.gov.

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