Actively Recruiting
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Led by Cellectis S.A. · Updated on 2025-09-09
52
Participants Needed
19
Research Sites
350 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- B-ALL blast cells expressing CD22
- Diagnosed with relapsed or refractory B-ALL
- Prior therapy must include at least one standard chemotherapy regimen and at least one salvage regimen
You will not qualify if you...
- Prior cellular therapy or investigational cellular or gene therapy within 90 days prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
University of California, Los Angeles (UCLA) - Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
2
University of Colorado - Aurora Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Sarah Cannon - Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
4
University of Chicago
Chicago, Illinois, United States, 60647
Actively Recruiting
5
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Actively Recruiting
7
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, 10021
Actively Recruiting
8
Weill Medical College of Cornell University
New York, New York, United States, 10065
Withdrawn
9
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
10
Sarah Cannon - HCA Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
11
Sarah Cannon - St. David's South Austin Medical Center
Austin, Texas, United States, 78704
Actively Recruiting
12
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
13
Sarah Cannon - Texas Transplant Institute at Methodist Hospital
San Antonio, Texas, United States, 78229
Actively Recruiting
14
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
15
CHU de Nantes - Hôtel-Dieu
Nantes, France, 44093
Actively Recruiting
16
Hôpital Saint Louis, Unité d'Hématologie Adolescents et Jeunes Adultes Département d'Hématologie
Paris, France, 75010
Actively Recruiting
17
Hôpital Robert Debré - Service d'hémato-immunologie
Paris, France, 75019
Actively Recruiting
18
Hôpital Lyon Sud
Pierre-Bénite, France, 69310
Actively Recruiting
19
CHU Rennes - Hopital Pontchaillou
Rennes, France, 35033
Actively Recruiting
Research Team
C
Cellectis Central Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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