Actively Recruiting
CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia
Led by St. Jude Children's Research Hospital · Updated on 2026-03-25
25
Participants Needed
1
Research Sites
305 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
CAR19PK is a research study evaluating the use of lymphodepleting chemotherapy and chimeric antigen receptor (CAR) T cell therapy, a type of cellular therapy, for the treatment of refractory and/or relapsed leukemia. For this type of therapy, peripheral (circulating) immune cells are collected and then modified so that they can recognize an antigen, which is a particle present on the surface of a cancer cell. The CD19-CAR T cell product will be manufactured at the St. Jude Children's Research Hospital's Good Manufacturing Practice (GMP) facility. The main purpose of this study is to determine: * Evaluate different doses of fludarabine prior CAR T cell infusion * How your body processes fludarabine and cyclophosphamide, * How long the CAR T cells last in the body, * Whether or not treatment with this therapy is effective in treating people with refractory or relapsed leukemia, and * The side effects of this therapy.
CONDITIONS
Official 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...
- Patient has CD19-positive leukemia with refractory disease, second or greater relapse, any relapse after allogeneic hematopoietic cell transplantation, or first relapse requiring but unsuitable for allogeneic transplant
- Age 21 years or younger
- Karnofsky or Lansky performance score 50 or higher
- Estimated life expectancy greater than 12 weeks for cell collection and greater than 8 weeks for treatment
- Clinically recovered from prior transplant with no active graft versus host disease and no donor lymphocyte infusion in last 28 days
- Female patients of childbearing potential must not be pregnant or lactating and must have a negative pregnancy test within 7 days prior to enrollment
- Detectable disease prior to planned CAR T cell infusion
- Adequate cardiac, renal, and pulmonary function as defined by study criteria
- Recovery from prior therapy toxicities to grade II or less
- Agreement to use birth control until 6 months after T cell infusion if sexually active and of childbearing potential
You will not qualify if you...
- Known primary immunodeficiency
- History of HIV infection
- Severe active bacterial, viral, or fungal infection
- History of allergic reactions to murine protein-containing products
- Contraindication to lymphodepleting chemotherapy regimen
- Active central nervous system (CNS-3) disease
- Evidence of active, uncontrolled neurologic disease
AI-Screening
AI-Powered Screening
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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
CONTACT
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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