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 USA 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

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)

Incidence of AE/SAE/DLT [Safety and Tolerability] — 24 Months
Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study in relation to UCART22 and/or lymphodepletion
Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs) — Up to D28 post initial UCART22 infusion

Trial sites (19)

Facility	City	Region	Status
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Weill Medical College of Cornell University	New York	New York	Withdrawn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 the USA

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

Study Evaluating Safety and Efficacy of UCART123v1.2 in Patients With Relapsed/Refractory Acute Myeloid Leukemia Active, not recruiting

Other trials for the same condition

Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients Active, not recruiting

Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01) Recruiting

Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL) Recruiting

Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19) Recruiting

Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies 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 the USA