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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)


Description

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)

Trial 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 Info

Organization

Cellectis S.A.


Primary Outcome

Incidence of AE/SAE/DLT [Safety and Tolerability]


Outcome Timeframe 24 Months

NCTID NCT04150497

Phases PHASE1,PHASE2

Primary Purpose TREATMENT

Start Date 2019-10-14

Completion Date 2026-01-31

Enrollment Target 40

Interventions

BIOLOGICAL UCART22

BIOLOGICAL CLLS52

Locations Recruiting

University of California, Los Angeles (UCLA) - Medical Center

United States, California, Los Angeles


University of Colorado - Aurora Cancer Center

United States, Colorado, Aurora


Sarah Cannon - Colorado Blood Cancer Institute

United States, Colorado, Denver


University of Chicago

United States, Illinois, Chicago


Dana Farber Cancer Institute

United States, Massachusetts, Boston


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