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

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT06847269
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    Given IV
  • Cyclophosphamide — DRUG
    Given IV
  • Mesna — DRUG
    Given IV
  • CD19-CAR T cell Infusion — BIOLOGICAL
    Patients will receive the CD19-CAR T cells by vein, through either an IV or a central line.

Study Details

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.

Key Dates

Start date
May 21, 2025
Status verified
Mar 2026
Primary completion
Mar 31, 2030
Completion
Apr 30, 2031

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CAR19PK Therapy
    This study contains two phases. Collection and Manufacturing Phase: Patient blood cells will be collected, and possibly frozen, via a process called apheresis. These cells will then be changed to improve their ability to recognize and kill cancer cells. Treatment Phase: Patients that meet eligibility for treatment will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by an infusion of CD19-CAR T cells that were made in the Collection and Manufacturing Phase.

Primary Outcome Measure

Fludarabine Pharmacokinetics [ Time Frame: Days -5, -4 and -3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Aimee Talleur, MD
[email protected]
866-278-5833
Aimee Talleur, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Memphis, TN

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
St. Jude Children's Research Hospital· Memphis, TN

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