Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Recruiting now · Phase 1/Phase 2
Conditions studied: B-cell Acute Lymphoblastic Leukemia
In brief
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)
Key facts
- Study ID
- NCT04150497
- Run by
- Cellectis S.A.
- People needed
- 52
- Starts
- 2019-10-14
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2025-09-09
Who can join
Age: 15 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Prior cellular therapy or investigational cellular or gene therapy within 90 days prior to enrollment
Where it is running
- CHU Rennes - Hopital Pontchaillou — Rennes, France (enrolling)
- University of Colorado - Aurora Cancer Center — Aurora, Colorado, United States (enrolling)
- Sarah Cannon - Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
- University of Chicago — Chicago, Illinois, United States (enrolling)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (enrolling)
- 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 (enrolling)
- University of California, Los Angeles (UCLA) - Medical Center — Los Angeles, California, United States (enrolling)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
- Sarah Cannon - HCA Research Institute — Nashville, Tennessee, United States (enrolling)
- Sarah Cannon - St. David's South Austin Medical Center — Austin, Texas, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Sarah Cannon - Texas Transplant Institute at Methodist Hospital — San Antonio, Texas, United States (enrolling)
- University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States (enrolling)
- CHU de Nantes - Hôtel-Dieu — Nantes, France (enrolling)
- Hôpital Saint Louis, Unité d'Hématologie Adolescents et Jeunes Adultes Département d'Hématologie — Paris, France (enrolling)
- Hôpital Robert Debré - Service d'hémato-immunologie — Paris, France (enrolling)
- Hôpital Lyon Sud — Pierre-Bénite, France (enrolling)
- Weill Medical College of Cornell University — New York, New York, United States
Full record on ClinicalTrials.gov
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