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CAR T Cell Therapy for Pediatric and Young Adult CD19-Positive Leukemia

This research study, called CAR19PK, is looking at a treatment for children and young adults (up to 21 years old) with CD19-positive leukemia that has come back or hasn't responded to other treatments. The treatment involves giving you chemotherapy drugs, fludarabine and cyclophosphamide, along with Mesna, followed by an infusion of special immune cells called CD19-CAR T cells. These CAR T cells are made from your own cells and are designed to find and fight cancer cells. The study aims to understand how your body handles fludarabine and cyclophosphamide, how long the CAR T cells stay in your body, and to evaluate different doses of fludarabine. We are looking to enroll 25 patients for this study.

Study design
This is an interventional study with a planned enrollment of 25 participants. It is a Phase II study evaluating lymphodepleting chemotherapy followed by CAR T cell infusion.
What's involved
You would undergo a two-part consent process, first for collecting your immune cells (autologous apheresis) and then for receiving the chemotherapy and CAR T cell infusion. You will receive a single course of chemotherapy followed by a single infusion of CD19-CAR T cells.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Fludarabine Pharmacokinetics, is measured at Days -5, -4, and -3. How long CAR T cells last in the body is also being studied.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06847269

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

Recruiting
PHASE2Up to 21InterventionalTreatment
St. Jude Children's Research Hospital
~25 participants
Updated 2026-03-25 on ClinicalTrials.gov
What's tested:FludarabineCyclophosphamideMesnaCD19-CAR T cell Infusion

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fludarabine Pharmacokinetics
Measured over Days -5, -4 and -3

Conditions

Acute Lymphoblastic Leukemia
Refractory Acute Lymphoblastic Leukemia

Explore related trials

Acute Lymphoblastic LeukemiaCD19 Gene

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Aimee Talleur, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

Who to contact

Aimee Talleur, MD
[email protected]
8662785833
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

CD19+ leukemia\*\* with any of the following:
Refractory disease (primary or in relapse)
2nd or greater relapse
Any relapse after allogeneic hematopoietic cell transplantation
1st relapse if patient requires an allogeneic HCT as part of standard of care relapse therapy, but is found to be ineligible and/or unsuitable for HCT
must be confirmed to be CD19+ within 3 months prior to enrollment for treatment
Age: ≤ 21 years of age
Karnofsky or Lansky (age-dependent) performance score ≥ 50 (Appendix A)
Estimated life expectancy of \> 12 weeks. Patients with a history of prior allogeneic hematopoietic cell transplantation \[HCT\] must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to apheresis
For females of child bearing age:
Not lactating with intent to breastfeed
Not pregnant with negative serum pregnancy test within 7 days prior to enrollment
Age: ≤ 21 years of age
Estimated life expectancy of \> 8 weeks
Detectable disease
Prior to planned CAR T cell infusion, patients with a history of prior allogeneic HCT must:
be at least 3 months from HCT
have no evidence of active GVHD
have not received a donor lymphocyte infusion (DLI) within the 28 days prior to planned infusion
Adequate cardiac function defined as left ventricular ejection fraction \> 40%, or shortening fraction ≥ 25%
EKG without evidence of clinically significant arrhythmia
Adequate renal function defined as creatinine clearance or radioisotope GFR ³ 50 ml/min/1.73m2 (GFR ³ 40 ml/min/1.73m2 if \< 2 years of age)
Adequate pulmonary function defined as forced vital capacity (FVC) ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing
Karnofsky or Lansky (age-dependent) performance score ≥ 50 (Appendix A)
Total Bilirubin ≤ 3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age
Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy
For patients of child bearing age:
Not lactating with intent to breastfeed
Not pregnant with negative serum pregnancy test within 7 days prior to enrollment
If sexually active, agreement to use birth control until 6 months after T cell infusion.

Exclusion

Known primary immunodeficiency
History of HIV infection
Severe intercurrent bacterial, viral or fungal infection
History of hypersensitivity reactions to murine protein-containing products
Known contraindication to receiving protocol defined lymphodepleting chemotherapy regimen
Active CNS-3 disease
Known primary immunodeficiency
History of HIV infection
Evidence of active, uncontrolled neurologic disease
Severe, uncontrolled bacterial, viral or fungal infection
History of hypersensitivity reactions to murine protein-containing products
Known contraindication to receiving protocol defined lymphodepleting chemotherapy regimen

What this trial measures

  • Fludarabine PharmacokineticsDays -5, -4 and -3

    Determination of Fludarabine exposure (area under the curve \[AUC\], mg-hr/L) using blood samples collected on days -5, -4 and -3