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

RECRUITINGPhase 1/2Sponsored by Cellectis S.A.
Actively Recruiting
PhasePhase 1/2
SponsorCellectis S.A.
Started2019-10-14
Est. completion2026-06-30
Eligibility
Age15 Years – 50 Years
Healthy vol.Accepted
Locations14 sites
View on ClinicalTrials.gov →

NCT04150497

Summary

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)

Eligibility

Age: 15 Years – 50 YearsHealthy volunteers accepted
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 90 days prior to enrollment

Conditions2

B-cell Acute Lymphoblastic LeukemiaCancer

Locations14 sites

University of California, Los Angeles (UCLA) - Medical Center
Los Angeles, California, 90095
University of Colorado - Aurora Cancer Center
Aurora, Colorado, 80045
Sarah Cannon - Colorado Blood Cancer Institute
Denver, Colorado, 80218
University of Chicago
Chicago, Illinois, 60647
Dana Farber Cancer Institute
Boston, Massachusetts, 02215

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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