RecruitingPhase 1Phase 2NCT04150497

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

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)

Sponsor

Cellectis S.A.

Enrollment

52 participants

Start Date

Oct 14, 2019

Study Type

INTERVENTIONAL

Conditions

B-cell Acute Lymphoblastic Leukemia

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

Min Age: 15 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy called UCART22 for patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back or stopped responding to treatment. UCART22 uses lab-engineered T cells from a healthy donor (not the patient) that are designed to target and destroy leukemia cells carrying a protein called CD22. **You may be eligible if...** - Your leukemia cells carry the CD22 protein - You have relapsed or refractory B-ALL (the cancer came back or didn't respond to treatment) - You have already tried at least one standard chemotherapy and at least one salvage (rescue) treatment **You may NOT be eligible if...** - You received a prior cellular therapy or experimental gene/cell therapy within the last 90 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALUCART22

Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen

BIOLOGICALCLLS52

A monoclonal antibody that recognizes a CD52 antigen

Locations(19)

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

Los Angeles, California, United States

University of Colorado - Aurora Cancer Center

Aurora, Colorado, United States

Sarah Cannon - Colorado Blood Cancer Institute

Denver, Colorado, United States

University of Chicago

Chicago, Illinois, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 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, United States

Weill Medical College of Cornell University

New York, New York, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Sarah Cannon - HCA Research Institute

Nashville, Tennessee, United States

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

Austin, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Sarah Cannon - Texas Transplant Institute at Methodist Hospital

San Antonio, Texas, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

CHU de Nantes - Hôtel-Dieu

Nantes, France

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

Paris, France

Hôpital Robert Debré - Service d'hémato-immunologie

Paris, France

Hôpital Lyon Sud

Pierre-Bénite, France

CHU Rennes - Hopital Pontchaillou

Rennes, France

View Full Details on ClinicalTrials.gov

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NCT04150497

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