Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Sponsor: Cellectis S.A.
ClinicalTrials ID:NCT04150497
This Phase 1/2 study evaluates the safety and clinical activity of UCART22, an allogeneic T-cell therapy targeting CD22, in patients with relapsed or refractory B-ALL. Eligible participants must have CD22+ B-ALL and prior treatment with standard and salvage regimens. The study also involves CLLS52, a monoclonal antibody targeting CD52, following a lymphodepleting regimen.
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Program Overview
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)
Eligibility 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 60 days prior to enrollment
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