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Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Trial Status: active
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)
Inclusion Criteria
Inclusion 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
Exclusion Criteria:
-Prior cellular therapy or investigational cellular or gene therapy within 90 days prior
to enrollment
Additional locations may be listed on ClinicalTrials.gov for NCT04150497.
