RecruitingRecruiting
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
NCT04150497 · Cellectis S.A.
In plain English
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Official title
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)
About this study
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 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
Exclusion Criteria:
-Prior cellular therapy or investigational cellular or gene therapy within 90 days prior to enrollment
Study design
Enrollment target: 52 participants
Allocation: na
Masking: none
Age groups: child, adult
Timeline
Starts: 2019-10-14
Estimated completion: 2026-06-30
Last updated: 2025-09-09
Interventions
Biological: UCART22Biological: CLLS52
Primary outcomes
- • Incidence of AE/SAE/DLT [Safety and Tolerability] (24 Months)
- • Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs) (Up to D28 post initial UCART22 infusion)
Sponsor
Cellectis S.A. · industry
Contacts & investigators
ContactCellectis Central Contact · contact · clinicaltrials@cellectis.com · +1 (347) 752-4044
InvestigatorNitin Jain, MD · principal_investigator, M.D. Anderson Cancer Center
All locations (19)
University of California, Los Angeles (UCLA) - Medical CenterRecruiting
Los Angeles, California, United States
University of Colorado - Aurora Cancer CenterRecruiting
Aurora, Colorado, United States
Sarah Cannon - Colorado Blood Cancer InstituteRecruiting
Denver, Colorado, United States
University of ChicagoRecruiting
Chicago, Illinois, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Roswell Park Comprehensive Cancer CenterRecruiting
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Weill Medical College of Cornell UniversityWithdrawn
New York, New York, United States
Children's Hospital of PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
Sarah Cannon - HCA Research InstituteRecruiting
Nashville, Tennessee, United States
Sarah Cannon - St. David's South Austin Medical CenterRecruiting
Austin, Texas, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Sarah Cannon - Texas Transplant Institute at Methodist HospitalRecruiting
San Antonio, Texas, United States
University of Wisconsin Carbone Cancer CenterRecruiting
Madison, Wisconsin, United States
CHU de Nantes - Hôtel-DieuRecruiting
Nantes, France
Hôpital Saint Louis, Unité d'Hématologie Adolescents et Jeunes Adultes Département d'HématologieRecruiting
Paris, France
Hôpital Robert Debré - Service d'hémato-immunologieRecruiting
Paris, France
Hôpital Lyon SudRecruiting
Pierre-Bénite, France
CHU Rennes - Hopital PontchaillouRecruiting
Rennes, France