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

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)

Conditions

B-cell Acute Lymphoblastic Leukemia

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Study Overview

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Study Details

Study overview

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)

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)

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

Condition
B-cell Acute Lymphoblastic Leukemia
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of California, Los Angeles (UCLA) - Medical Center, Los Angeles, California, United States, 90095

Aurora

University of Colorado - Aurora Cancer Center, Aurora, Colorado, United States, 80045

Denver

Sarah Cannon - Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218

Chicago

University of Chicago, Chicago, Illinois, United States, 60647

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Buffalo

Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States, 14263

New York

Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10021

New York

Weill Medical College of Cornell University, New York, New York, United States, 10065

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Nashville

Sarah Cannon - HCA Research Institute, Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

15 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cellectis S.A.,

Nitin Jain, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2026-01-31