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Clinical Trials in France / NCT04150497
Recruiting Phase 1/2

Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)

NCT04150497 · tracked via the Priya Life Science France tracker
Sponsor
Cellectis S.A
Phase
Phase 1/2
Started
2019-10-14
Last updated
2025-09-09

Condition(s) studied

B-cell Acute Lymphoblastic Leukemia

Investigational drug(s) / intervention(s)

UCART22CLLS52 →

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

Study summary

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

Sex
ALL
Min age
15 Years
Max age
50 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
University of California, Los Angeles (UCLA) - Medical Center Los Angeles California Recruiting
University of Colorado - Aurora Cancer Center Aurora Colorado Recruiting
Sarah Cannon - Colorado Blood Cancer Institute Denver Colorado Recruiting
University of Chicago Chicago Illinois Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
Roswell Park Comprehensive Cancer Center Buffalo New York Recruiting
Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center New York New York Recruiting
Weill Medical College of Cornell University New York New York Withdrawn
Children's Hospital of Philadelphia Philadelphia Pennsylvania Recruiting
Sarah Cannon - HCA Research Institute Nashville Tennessee Recruiting
Sarah Cannon - St. David's South Austin Medical Center Austin Texas Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
Sarah Cannon - Texas Transplant Institute at Methodist Hospital San Antonio Texas Recruiting
University of Wisconsin Carbone Cancer Center Madison Wisconsin Recruiting
CHU de Nantes - Hôtel-Dieu Nantes France Recruiting
Hôpital Saint Louis, Unité d'Hématologie Adolescents et Jeunes Adultes Département d'Hématologie Paris France Recruiting
Hôpital Robert Debré - Service d'hémato-immunologie Paris France Recruiting
Hôpital Lyon Sud Pierre-Bénite France Recruiting
CHU Rennes - Hopital Pontchaillou Rennes France Recruiting

More Cellectis S.A. trials in France

Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma Recruiting

Other trials for the same condition

Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01) Recruiting
Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04150497 on ClinicalTrials.gov ↗ ← All trials in France