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CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia

StatusRecruiting
PhasePhase 2
Started2025-05-21
View on ClinicalTrials.gov ↗

Amendment history

2026-03-24
minor
Study Status v4
Re-verified, no change to tracked fields
2025-10-23
minor
Study Status v3
Start dateestimated 2025-08→confirmed 2025-05-21
2025-05-21
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2025-05-14
minor
Study Status v1
Start date2025-04→2025-08
2025-02-21
minor
Original filing
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.
Trial Details
NCT Number NCT06847269
Lead Sponsor St. Jude Children's Research Hospital
Conditions Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia
Enrollment 25 participants
Start Date 2025-05-21
Primary Completion 2030-03 (estimated)
Study Completion 2031-04 (estimated)
Updated on ClinicalTrials.gov 2026-03-25