Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01) (NCT04150497)
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)
🩺 Plain-English Summary (8th-Grade Level)
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)
Who can join: Review the eligibility criteria below.
Location: University of California, Los Angeles (UCLA) - Medical Center — Los Angeles, California
Age range: 15 Years to 50 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (19 Sites)
- University of California, Los Angeles (UCLA) - Medical Center — Los Angeles, California
- University of Colorado - Aurora Cancer Center — Aurora, Colorado
- Sarah Cannon - Colorado Blood Cancer Institute — Denver, Colorado
- University of Chicago — Chicago, Illinois
- Dana Farber Cancer Institute — Boston, Massachusetts
- Roswell Park Comprehensive Cancer Center — Buffalo, New York
- Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York
- Weill Medical College of Cornell University — New York, New York
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Sarah Cannon - HCA Research Institute — Nashville, Tennessee
- Sarah Cannon - St. David's South Austin Medical Center — Austin, Texas
- MD Anderson Cancer Center — Houston, Texas
- Sarah Cannon - Texas Transplant Institute at Methodist Hospital — San Antonio, Texas
- University of Wisconsin Carbone Cancer Center — Madison, Wisconsin
- CHU de Nantes - Hôtel-Dieu — Nantes,
- Hôpital Saint Louis, Unité d'Hématologie Adolescents et Jeunes Adultes Département d'Hématologie — Paris,
- Hôpital Robert Debré - Service d'hémato-immunologie — Paris,
- Hôpital Lyon Sud — Pierre-Bénite,
- CHU Rennes - Hopital Pontchaillou — Rennes,
📞 Contact the Study Coordinator
Phone: (347) 752-4044
Email: clinicaltrials@cellectis.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in B-cell Acute Lymphoblastic Leukemia
- A Second Infusion (Early Reinfusion) of Tisagenlecleucel in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia(B-ALL) — Los Angeles, California
- A Phase 1b/2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Combination With Low Intensity Chemotherapy in Older Patients With Newly Diagnosed B-Cell Acute Lymphoblastic Leukemia — Houston, Texas
- Venetoclax Plus Inotuzumab for B-ALL — Boston, Massachusetts
- Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients — Birmingham, Alabama
- Study Of KITE-753 in R/R B-Cell ALL — Houston, Texas
- A Study of Inotuzumab and Blinatumomab in People With B-cell Acute Lymphoblastic Leukemia — New York, New York
Explore by condition: All B-cell Acute Lymphoblastic Leukemia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.