RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

Open Label Dose-escalation and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCART22 (Allogeneic Engineered T-cells Expressing Anti-CD22 Chimeric Antigen Receptor) in Patients With Relapsed or refractoryCD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)

Quick Facts

Study Start:2019-10-14
Study Completion:2026-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04150497

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * B-ALL blast cells expressing CD22
  2. * Diagnosed with R/R B-ALL
  3. * Prior therapy must include at least one standard chemotherapy regimen and at least one salvage regimen
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Cellectis Central Contact
CONTACT
+1 (347) 752-4044
clinicaltrials@cellectis.com

Principal Investigator

Nitin Jain, MD
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

University of California, Los Angeles (UCLA) - Medical Center
Los Angeles, California, 90095
United States
University of Colorado - Aurora Cancer Center
Aurora, Colorado, 80045
United States
Sarah Cannon - Colorado Blood Cancer Institute
Denver, Colorado, 80218
United States
University of Chicago
Chicago, Illinois, 60647
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
United States
Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10021
United States
Weill Medical College of Cornell University
New York, New York, 10065
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Sarah Cannon - HCA Research Institute
Nashville, Tennessee, 37203
United States
Sarah Cannon - St. David's South Austin Medical Center
Austin, Texas, 78704
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Sarah Cannon - Texas Transplant Institute at Methodist Hospital
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Cellectis S.A.

  • Nitin Jain, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-14
Study Completion Date2026-01-31

Study Record Updates

Study Start Date2019-10-14
Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

  • 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®)

Additional Relevant MeSH Terms

  • B-cell Acute Lymphoblastic Leukemia