Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Sponsor: Cellectis S.A.
ClinicalTrials ID:NCT04150497
This Phase 1/2 study evaluates the safety and clinical activity of UCART22, an allogeneic T-cell therapy targeting CD22, in patients with relapsed or refractory B-ALL. Eligible participants must have CD22+ B-ALL and prior treatment with standard and salvage regimens. The study also involves CLLS52, a monoclonal antibody targeting CD52, following a lymphodepleting regimen.
Patient Parameters
| Parameter | Options |
|---|
Program 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)
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 60 days prior to enrollment
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California, Los Angeles (UCLA) - Medical Center | 90095 | Los Angeles | California |
| University of Colorado - Aurora Cancer Center | 80045 | Aurora | Colorado |
| Sarah Cannon - Colorado Blood Cancer Institute | 80218 | Denver | Colorado |
| University of Chicago | 60647 | Chicago | Illinois |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Roswell Park Comprehensive Cancer Center | 14263 | Buffalo | New York |
| Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center | 10021 | New York | New York |
| Weill Medical College of Cornell University | 10065 | New York | New York |
| Children's Hospital of Philadelphia | 19104 | Philadelphia | Pennsylvania |
| Sarah Cannon - HCA Research Institute | 37203 | Nashville | Tennessee |
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