Status:
RECRUITING
CD19x22 Chimeric Antigen Receptor T-cell Therapy (CAR T) in Pediatric B-ALL
Lead Sponsor:
University of Colorado, Denver
Conditions:
B-cell Acute Lymphoblastic Leukemia
Eligibility:
All Genders
3-30 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
This is an open-label Phase I trial consisting of 2 cohorts to determine the safety and tolerability of CD19x22 CAR T in Pediatric Patients with R/R B-ALL. This trial will include two parallel cohorts...
Eligibility Criteria
Inclusion
- Subjects must have a history of B precursor ALL with any of the following conditions:
- Relapsed two or more times.
- Relapsed at any time after allogeneic bone marrow transplant (BMT).
- Relapse or refractory after single antigen targeting CAR T cell therapy.
- i. 90 days must have elapsed post previous CAR infusion prior to apheresis. d. Refractory to standard therapy as determined by the treating physician. e. Patient and/or parents declining BMT options and would prefer CAR T Therapy.
- CD19 and/or CD22 present on last relapsed/refractory disease evaluation.
- Performance score (Lansky or Karnofsky ≥ 50%; or Eastern Cooperative Oncology Group (ECOG) must be ≤2).
- Meets criteria for potential leukapheresis collection or has leukapheresis product previously collected and stored per recommended guidelines.
- Males OR non-pregnant, non-lactating females.
- Aged 3 months to 30 years (inclusive) at time of consent and enrollment.
- Provision of a signed and dated consent form from parent or guardian (patients \< 18), the patient themselves (\> 18), or legally authorized representative (patient \> 18 who lack decision-making capacity) after standard of care (SOC) screening assessments are performed.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Willingness to participate in long-term follow-up protocol.
Exclusion
- Active, uncontrolled central nervous system (CNS) leukemia that is progressive despite other therapies or leading to CNS symptoms (including but not limited to: seizures, paresis, aphasia, hemorrhage, dementia, psychosis, or movement disorders) as determined by the treating physician at eligibility, prior to lymphodepleting chemotherapy (LD chemo), and pre- CD19x22 CAR T cell infusion.
- History of allogeneic stem cell transplantation prior to apheresis that meet the following criteria:
- Less than 100 days post-transplant;
- Evidence of active Graft-versus-Host Disease (GvHD) requiring systemic therapy;
- Less than 6 weeks post donor lymphocyte infusion (DLI).
- Active, uncontrolled, life-threatening infection that at the determination of the treating physician would preclude safe apheresis or tolerance of lymphodepleting chemotherapy, cell infusion, or increased risk of cytokine release syndrome.
- Evidence of severe organ dysfunction defined by:
- Baseline oxygen saturation of \< 90% on room air
- Myocardial dysfunction (based on age standards): Ejection fraction ≤ 40% or shortening fraction ≤ 28%, evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and clinically significant electrocardiogram (ECG or EKG) findings
- Transaminases \> 10x upper limit of normal (ULN) or bilirubin \> 5x the ULN, unless thought to be related to primary disease
- Estimated Creatinine (Cr) clearance \< 60 mL/min/1.73 m2 (if nuclear medicine GFR or other more specific testing exceeds this level than it can supersede the estimated clearance)
- Subjects of childbearing or child-fathering potential that are not willing to practice birth control from the time of enrollment on this study and for 12 months after receiving the investigational product
- Known HIV infection or active Hepatitis B or Hepatitis C infection.
Key Trial Info
Start Date :
September 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT06559189
Start Date
September 27 2024
End Date
December 1 2029
Last Update
November 28 2025
Active Locations (1)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045