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OncoMatch/Clinical Trials/NCT04150497

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

Is NCT04150497 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including UCART22 and CLLS52 for b-cell acute lymphoblastic leukemia.

Phase 1/2RecruitingCellectis S.A.NCT04150497Data as of May 2026

Treatment: UCART22 · CLLS52This 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)

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Extracted eligibility criteria

Cancer type

Acute Lymphoblastic Leukemia

Biomarker criteria

Required: CD22 expression

Prior therapy

Min 2 prior lines

Must have received: chemotherapy — standard

at least one standard chemotherapy regimen

Must have received: chemotherapy — salvage

at least one salvage regimen

Cannot have received: cellular therapy

Prior cellular therapy or investigational cellular or gene therapy within 90 days prior to enrollment

Cannot have received: gene therapy

Prior cellular therapy or investigational cellular or gene therapy within 90 days prior to enrollment

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of California, Los Angeles (UCLA) - Medical Center · Los Angeles, California
  • University of Colorado - Aurora Cancer Center · Aurora, Colorado
  • Sarah Cannon - Colorado Blood Cancer Institute · Denver, Colorado
  • University of Chicago · Chicago, Illinois
  • Dana Farber Cancer Institute · Boston, Massachusetts

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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