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Search / Trial NCT04150497

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

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®)

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.

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

0 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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