NCT04150497PHASE1, PHASE2Recruiting

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

Cellectis S.A.

Start Date

10/14/2019

Completion Date

6/30/2026

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 Criteria

Age Range: 15 years to 50 years

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

Interventions

BIOLOGICAL

UCART22

BIOLOGICAL

CLLS52

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Conditions

B-cell Acute Lymphoblastic Leukemia

Locations

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

Los Angeles, California 90095

United States

University of Colorado - Aurora Cancer Center

Aurora, Colorado 80045

United States

Sarah Cannon - Colorado Blood Cancer Institute

Denver, Colorado 80218

United States

University of Chicago

Chicago, Illinois 60647

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York 14263

United States

Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York 10021

United States

Weill Medical College of Cornell University

New York, New York 10065

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Sarah Cannon - HCA Research Institute

Nashville, Tennessee 37203

United States

Sarah Cannon - St. David's South Austin Medical Center

Austin, Texas 78704

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Sarah Cannon - Texas Transplant Institute at Methodist Hospital

San Antonio, Texas 78229

United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin 53792

United States

CHU de Nantes - Hôtel-Dieu

Nantes, 44093

France

Hôpital Saint Louis, Unité d'Hématologie Adolescents et Jeunes Adultes Département d'Hématologie

Paris, 75010

France

Hôpital Robert Debré - Service d'hémato-immunologie

Paris, 75019

France

Hôpital Lyon Sud

Pierre-Bénite, 69310

France

CHU Rennes - Hopital Pontchaillou

Rennes, 35033

France