Actively Recruiting
CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia: An Investigation of Lymphodepleting Chemotherapy Pharmacokinetics
Led by St. Jude Children's Research Hospital · Updated on 2026-03-25
25
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment approach for children, adolescents, and young adults aged 21 years or younger who have relapsed or refractory CD19-positive acute lymphoblastic leukemia. This Phase II study aims to assess different doses of the chemotherapy drug fludarabine before infusion of CAR T cell therapy, how the body processes the chemotherapy drugs fludarabine and cyclophosphamide, the persistence of CAR T cells in the body, treatment effectiveness, and potential side effects. The treatment involves two main phases. First, blood cells are collected through apheresis and modified in a lab to better recognize and attack leukemia cells, creating CD19-CAR T cells. Next, patients receive lymphodepleting chemotherapy with age-based dosing of fludarabine and cyclophosphamide. This is followed by a single infusion of the modified CAR T cells given intravenously, dosed at 3 million CAR T cells per kilogram of body weight. The study includes a two-part consent process covering cell collection and treatment phases. Participants will undergo assessments including monitoring of fludarabine levels on days before CAR T cell infusion and evaluations of heart, kidney, and lung function. Researchers will track how long the CAR T cells remain in the body and watch for side effects. The study involves regular clinical evaluations, laboratory tests, and performance scoring to ensure patient safety and measure treatment impact. Participation lasts through treatment and follow-up periods as defined by the protocol.
CONDITIONS
Brief Title
CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years or younger
- Diagnosis of CD19-positive leukemia with refractory disease, second or greater relapse, relapse after allogeneic hematopoietic cell transplantation, or first relapse if ineligible for transplant
- Confirmed CD19-positive status within 3 months prior to enrollment
- Karnofsky or Lansky performance score of 50 or higher
- Estimated life expectancy greater than 12 weeks (for apheresis) and greater than 8 weeks (for treatment)
- For females of childbearing potential: not pregnant, not breastfeeding, and negative pregnancy test within 7 days prior to enrollment
- Adequate heart function (left ventricular ejection fraction > 40% or shortening fraction ≥ 25%)
- Adequate kidney function (creatinine clearance or GFR ≥ 50 ml/min/1.73m2; ≥ 40 ml/min/1.73m2 if under 2 years old)
- Adequate lung function (FVC ≥ 50% predicted or oxygen saturation ≥ 92% on room air)
- Recovery from prior severe non-hematologic toxicities
- No active graft-versus-host disease and no recent donor lymphocyte infusion if previously transplanted
You will not qualify if you...
- Known primary immunodeficiency
- History of HIV infection
- Severe or uncontrolled bacterial, viral, or fungal infection
- History of allergic reactions to murine protein-containing products
- Known contraindication to lymphodepleting chemotherapy regimen
- Active CNS-3 disease
- Evidence of active, uncontrolled neurologic disease
- Pregnant or breastfeeding females
- Karnofsky or Lansky performance score below 50
- Life expectancy less than required periods
- Recent donor lymphocyte infusion within 28 days prior to treatment or apheresis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies based on manufacturing time
Participants undergo apheresis to collect blood cells, which may be frozen and modified to create CD19-CAR T cells.
1 to 2 visits depending on apheresis and cell manufacturing schedules
Duration - Approximately 1 week covering chemotherapy and infusion
Participants receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by a single infusion of CD19-CAR T cells.
Multiple visits over about 1 week including chemotherapy administration and CAR T cell infusion
Trial Site Locations
Total: 1 location
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
A
Aimee Talleur, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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