Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
NCT ID: NCT04150497
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
52 participants
INTERVENTIONAL
2019-10-14
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Escalation
Several tested doses of UCART22 until the Maximum Tolerated Dose (MTD) is identified and establish Recommended Phase 2 Dose (RP2D)
Dose Expansion: UCART22 administered at the RP2D
UCART22
Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen
CLLS52
A monoclonal antibody that recognizes a CD52 antigen
Interventions
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UCART22
Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen
CLLS52
A monoclonal antibody that recognizes a CD52 antigen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with R/R B-ALL
* Prior therapy must include at least one standard chemotherapy regimen and at least one salvage regimen
Exclusion Criteria
15 Years
50 Years
ALL
No
Sponsors
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Cellectis S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Nitin Jain, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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UCART22_01
Identifier Type: -
Identifier Source: org_study_id
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