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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


Interested in joining this trial?

Our dedicated patient navigators are here to support you by reviewing the eligibility criteria to see if you might qualify for this trial.

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