OncoMatch/Clinical Trials/NCT04150497
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Is NCT04150497 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including UCART22 and CLLS52 for b-cell acute lymphoblastic leukemia.
Treatment: UCART22 · CLLS52 — 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)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD22 expression
Demographics
Prior therapy
Must have received: chemotherapy — standard
at least one standard chemotherapy regimen
Must have received: chemotherapy — salvage
at least one salvage regimen
Cannot have received: cellular therapy
Prior cellular therapy or investigational cellular or gene therapy within 90 days prior to enrollment
Cannot have received: gene therapy
Prior cellular therapy or investigational cellular or gene therapy within 90 days prior to enrollment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04150497 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cellular therapy, gene therapy disqualifies patients from enrollment.
Does this trial require CD22?
Yes, CD22 expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 50 years or younger and at least 15 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages