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

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

Recruiting
15-70 years
All
Phase 1
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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

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

Study details
    B-cell Acute Lymphoblastic Leukemia

NCT04150497

Cellectis S.A.

27 January 2024

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