Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
About the study
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)
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
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
Exclusion Criteria:
-Prior cellular therapy or investigational cellular or gene therapy within 60 days prior to enrollment
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
B-cell Acute Lymphoblastic Leukemia
Age
15+
Phase
PHASE1
Participants Needed
40
Est. Completion Date
Jan 31, 2026
Treatment Type
INTERVENTIONAL
Sponsor
Cellectis S.A.
ClinicalTrials.gov NCT Identifier
NCT04150497
Study Number
UCART22_01
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