Recruiting
Phase 1
Phase 2

UCART22

Sponsor:

Cellectis S.A.

Code:

NCT04150497

Conditions

B-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex: All

Age: 15 - 50

Healthy Volunteers: Not accepted

Interventions

UCART22

CLLS52

Study Details

Brief 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)

Conditions

B-cell Acute Lymphoblastic Leukemia

Study ID

NCT04150497

Start date

Oct 14, 2019

Status verified date

Sep, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

52 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation

Several tested doses of UCART22 until the Maximum Tolerated Dose (MTD) is identified and establish Recommended Phase 2 Dose (RP2D)

Dose Expansion: UCART22 administered at the RP2D

Interventions

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

Primary outcome measure

  • Incidence of AE/SAE/DLT [Safety and Tolerability] [ Time Frame: 24 Months ]
  • Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs) [ Time Frame: Up to D28 post initial UCART22 infusion ]

Central Contacts and Locations

Central contacts

Cellectis Central Contact

+1 (347) 752-4044clinicaltrials@cellectis.com

Locations

University of California, Los Angeles (UCLA) - Medical Center

Recruiting

Los Angeles, California, United States, 90095

University of Colorado - Aurora Cancer Center

Recruiting

Aurora, Colorado, United States, 80045

Sarah Cannon - Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

University of Chicago

Recruiting

Chicago, Illinois, United States, 60647

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Roswell Park Comprehensive Cancer Center

Recruiting

Buffalo, New York, United States, 14263

Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Sarah Cannon - HCA Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Sarah Cannon - St. David's South Austin Medical Center

Recruiting

Austin, Texas, United States, 78704

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Sarah Cannon - Texas Transplant Institute at Methodist Hospital

Recruiting

San Antonio, Texas, United States, 78229

University of Wisconsin Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

Cellectis S.A.

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • B-cell Acute Lymphoblastic Leukemia (B-ALL)
  • Relapse/Refractory B-ALL
  • Universal Chimeric Antigen Receptor T-Cell (UCAR-T) Therapy
  • Allogeneic
  • Transcription Activator-Like Effector Nuclease (TALEN®)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Cellectis S.A. on 2025-09-09.