Treatment for patients with relapsed or refractory B-cell acute lymphoblastic leukemia using UCART22
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)
This study is testing a new treatment called UCART22 to see if it can help people with relapsed or hard-to-treat B-cell acute lymphoblastic leukemia feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 15 Years to 50 Years |
| Sex | All |
| Sponsor | Cellectis S.A. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 19 sites (Los Angeles, California and 18 other locations) |
| Trial ID | NCT04150497 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of UCART22, a type of universal chimeric antigen receptor T-cell therapy, in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). It is a first-in-human, open-label study that involves a dose escalation and expansion approach to determine the maximum tolerated dose and the recommended phase 2 dose. Participants will receive UCART22 intravenously, and the study aims to assess how well this treatment works compared to existing therapies.
Who should consider this trial
Good fit: Ideal candidates are patients with relapsed or refractory B-ALL whose cancer cells express CD22 and have undergone at least one standard chemotherapy and one salvage regimen.
Not a fit: Patients who have received prior cellular therapy or investigational cellular or gene therapy within the last 60 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-ALL.
How similar studies have performed: Other studies using similar CAR-T therapies have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California and 18 other locations
- University of California, Los Angeles (UCLA) - Medical Center — Los Angeles, California, United States (Recruiting)
- University of Colorado - Aurora Cancer Center — Aurora, Colorado, United States (Recruiting)
- Sarah Cannon - Colorado Blood Cancer Institute — Denver, Colorado, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Weill Medical College of Cornell University — New York, New York, United States (Withdrawn)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Sarah Cannon - HCA Research Institute — Nashville, Tennessee, United States (Recruiting)
- Sarah Cannon - St. David's South Austin Medical Center — Austin, Texas, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Sarah Cannon - Texas Transplant Institute at Methodist Hospital — San Antonio, Texas, United States (Recruiting)
- University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States (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)
Study contacts
- Principal investigator: Nitin Jain, MD — M.D. Anderson Cancer Center
- Study coordinator: Cellectis Central Contact
- Email: clinicaltrials@cellectis.com
- Phone: +1 (347) 752-4044
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.