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

Last updated: August 23, 2024
Sponsor: Cellectis S.A.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Leukemia

Lymphocytic Leukemia, Acute

Treatment

UCART22

CLLS52

Clinical Study ID

NCT04150497
UCART22_01
  • Ages 15-70
  • 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 60 days prior to enrollment

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: UCART22
Phase: 1/2
Study Start date:
October 14, 2019
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • CHU de Nantes - Hôtel-Dieu

    Nantes, 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

    Active - Recruiting

  • Hôpital Lyon Sud

    Pierre-Benite, 69310
    France

    Active - Recruiting

  • CHU Rennes - Hopital Pontchaillou

    Rennes, 35033
    France

    Active - Recruiting

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

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of Colorado - Aurora Cancer Center

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Sarah Cannon - Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60647
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 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, New York 10021
    United States

    Active - Recruiting

  • Weill Medical College of Cornell University

    New York, New York 10065
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Sarah Cannon - HCA Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

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

    Austin, Texas 78704
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Sarah Cannon - Texas Transplant Institute at Methodist Hospital

    San Antonio, Texas 78229
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.