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

  • Interventional
  • Recruiting
  • NCT04150497
Eligibility Details Visit

Open Label Dose-escalation and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCART22 (Allogeneic Engineered T-cells Expressing Anti-CD22 Chimeric Antigen Receptor) in Patients With Relapsed or refractoryCD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)

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)


Age Group
15 Years to 70 Years

Accepting Healthy Volunteers?

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

At a Glance

National Government IDNCT04150497


Lead SponsorCellectis S.A.

Lead PhysicianRichard Larson


15 Years to 70 Years