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

Last updated: September 8, 2025
Sponsor: Cellectis S.A.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphocytic Leukemia, Acute

Leukemia

Treatment

UCART22

CLLS52

Clinical Study ID

NCT04150497
UCART22_01
  • Ages 15-50
  • All Genders

Study 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

Inclusion

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 leastone salvage regimen

Exclusion

Exclusion Criteria:

-Prior cellular therapy or investigational cellular or gene therapy within 90 days prior to enrollment

Study Design

Total Participants: 52
Treatment Group(s): 2
Primary Treatment: UCART22
Phase: 1/2
Study Start date:
October 14, 2019
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • CHU de Nantes - Hôtel-Dieu

    Nantes, 44093
    France

    Site Not Available

  • CHU de Nantes - Hôtel-Dieu

    Nantes 2990969, 44093
    France

    Active - Recruiting

  • Hôpital Robert Debré - Service d'hémato-immunologie

    Paris, 75019
    France

    Active - Recruiting

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

    Paris, 75010
    France

    Site Not Available

  • Hôpital Robert Debré - Service d'hémato-immunologie

    Paris 2988507, 75019
    France

    Active - Recruiting

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

    Paris 2988507, 75010
    France

    Active - Recruiting

  • Hôpital Lyon Sud

    Pierre-Benite, 69310
    France

    Site Not Available

  • Hôpital Lyon Sud

    Pierre-Bénite 2987314, 69310
    France

    Active - Recruiting

  • CHU Rennes - Hopital Pontchaillou

    Rennes, 35033
    France

    Site Not Available

  • CHU Rennes - Hopital Pontchaillou

    Rennes 2983990, 35033
    France

    Active - Recruiting

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

    Los Angeles, California 90095
    United States

    Site Not Available

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

    Los Angeles 5368361, California 5332921 90095
    United States

    Active - Recruiting

  • University of Colorado - Aurora Cancer Center

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Sarah Cannon - Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Site Not Available

  • University of Colorado - Aurora Cancer Center

    Aurora 5412347, Colorado 5417618 80045
    United States

    Active - Recruiting

  • Sarah Cannon - Colorado Blood Cancer Institute

    Denver 5419384, Colorado 5417618 80218
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60647
    United States

    Site Not Available

  • University of Chicago

    Chicago 4887398, Illinois 4896861 60647
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14263
    United States

    Site Not Available

  • 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

    Site Not Available

  • Weill Medical College of Cornell University

    New York, New York 10065
    United States

    Site Not Available

  • Roswell Park Comprehensive Cancer Center

    Buffalo 5110629, New York 5128638 14263
    United States

    Active - Recruiting

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

    New York 5128581, New York 5128638 10021
    United States

    Active - Recruiting

  • Weill Medical College of Cornell University

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • Sarah Cannon - HCA Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Sarah Cannon - HCA Research Institute

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

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

    Austin, Texas 78704
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Sarah Cannon - Texas Transplant Institute at Methodist Hospital

    San Antonio, Texas 78229
    United States

    Site Not Available

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

    Austin 4671654, Texas 4736286 78704
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Sarah Cannon - Texas Transplant Institute at Methodist Hospital

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • University of Wisconsin Carbone Cancer Center

    Madison 5261457, Wisconsin 5279468 53792
    United States

    Active - Recruiting

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