Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Launched by CELLECTIS S.A. · Nov 1, 2019
Trial Information
Current as of October 20, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called BALLI-01, is looking at a new treatment called UCART22 for patients with a type of blood cancer known as B-cell Acute Lymphoblastic Leukemia (B-ALL) that has come back or has not responded to previous treatments. The main goal of the study is to see how safe UCART22 is and how well it works. It will also help researchers figure out the best dose to give in future studies. The trial is currently open for participants aged between 18 and 75 who have B-ALL cells that express a protein called CD22 and have already tried at least one standard chemotherapy and one other treatment.
If you or a loved one join the trial, you will receive UCART22 through an intravenous (IV) line, which means it will be given directly into your bloodstream. Throughout the study, medical staff will closely monitor your health to ensure safety. It's important to note that individuals who have had certain types of gene therapy or cellular therapy within the last two months are not eligible to participate. This trial represents a promising opportunity for patients seeking new options for treating their B-ALL.
Gender
ALL
Eligibility criteria
- 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
About Cellectis S.A.
Cellectis S.A. is a pioneering biotechnology company focused on developing innovative cell and gene therapies for the treatment of cancer and genetic diseases. With a strong emphasis on harnessing the power of genome editing technologies, particularly its proprietary TALEN® platform, Cellectis aims to create transformative therapies that enhance the precision and efficacy of immunotherapy. The company is committed to advancing its robust pipeline of product candidates through rigorous clinical trials, collaborating with leading research institutions and industry partners to drive scientific progress and improve patient outcomes. Cellectis is dedicated to leveraging its expertise in genetic engineering to address unmet medical needs and contribute to the future of personalized medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Philadelphia, Pennsylvania, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Houston, Texas, United States
New York, New York, United States
Nantes, France
Buffalo, New York, United States
Chicago, Illinois, United States
Rennes, France
Aurora, Colorado, United States
Los Angeles, California, United States
New York, New York, United States
Paris, France
Paris, France
Paris, France
Paris, France
Pierre Benite, France
Denver, Colorado, United States
Nashville, Tennessee, United States
Austin, Texas, United States
San Antonio, Texas, United States
Patients applied
Trial Officials
Nitin Jain, MD
Principal Investigator
M.D. Anderson Cancer Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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