Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 15 Years to 50 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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)
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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
Study sites (14)
CA
- University of California, Los Angeles (UCLA) - Medical Center · Los Angeles, CA 90095More trials in Los Angeles
CO
- University of Colorado - Aurora Cancer Center · Aurora, CO 80045More trials in Aurora
- Sarah Cannon - Colorado Blood Cancer Institute · Denver, CO 80218More trials in Denver
IL
- University of Chicago · Chicago, IL 60647More trials in Chicago
MA
- Dana Farber Cancer Institute · Boston, MA 02215More trials in Boston
NY
- Roswell Park Comprehensive Cancer Center · Buffalo, NY 14263More trials in Buffalo
- Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center · New York, NY 10021More trials in New York
- Weill Medical College of Cornell University · New York, NY 10065More trials in New York
PA
- Children's Hospital of Philadelphia · Philadelphia, PA 19104More trials in Philadelphia
TN
- Sarah Cannon - HCA Research Institute · Nashville, TN 37203More trials in Nashville
TX
- Sarah Cannon - St. David's South Austin Medical Center · Austin, TX 78704More trials in Austin
- MD Anderson Cancer Center · Houston, TX 77030More trials in Houston
- Sarah Cannon - Texas Transplant Institute at Methodist Hospital · San Antonio, TX 78229More trials in San Antonio
WI
- University of Wisconsin Carbone Cancer Center · Madison, WI 53792More trials in Madison