Actively Recruiting
CD19x22 Chimeric Antigen Receptor T-cell Therapy (CAR T) in Pediatric B-ALL
Led by University of Colorado, Denver · Updated on 2025-11-28
53
Participants Needed
1
Research Sites
270 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the safety and tolerability of administering a novel bispecific CD19/CD22-directed CAR T cell product (CD19x22) for the treatment of relapsed or refractory pediatric B-ALL.
CONDITIONS
Official Title
CD19x22 Chimeric Antigen Receptor T-cell Therapy (CAR T) in Pediatric B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of B precursor acute lymphoblastic leukemia with either relapse two or more times, relapse after bone marrow transplant, or relapse/refractory after single antigen CAR T cell therapy
- CD19 and/or CD22 present on last relapsed or refractory disease evaluation
- Performance score (Lansky or Karnofsky) at least 50%, or Eastern Cooperative Oncology Group (ECOG) score of 2 or less
- Eligible for leukapheresis collection or have previously collected leukapheresis product stored
- Male or non-pregnant, non-lactating female
- Age between 3 months and 30 years at time of consent and enrollment
- Signed and dated consent form from parent/guardian if under 18, or from patient or authorized representative if 18 or older
- Willingness to comply with all study procedures and to be available throughout the study
- Willingness to participate in long-term follow-up
You will not qualify if you...
- Active, uncontrolled central nervous system leukemia causing symptoms like seizures or movement disorders
- Less than 100 days since allogeneic stem cell transplant
- Evidence of active graft-versus-host disease requiring systemic therapy
- Less than 6 weeks since donor lymphocyte infusion
- Active, uncontrolled, life-threatening infection preventing safe treatment
- Severe organ dysfunction including oxygen saturation below 90%, heart function abnormalities, very high liver enzymes or bilirubin, or low kidney function
- Not willing to use birth control during study and for 12 months after treatment if of childbearing or child-fathering potential
- Known HIV infection or active Hepatitis B or C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
V
Vanessa Fabrizio, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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