Recruiting
Phase 2

CAR T Cell

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT06847269

Conditions

Acute Lymphoblastic Leukemia

Refractory Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Fludarabine

Cyclophosphamide

Mesna

CD19-CAR T cell Infusion

Study Details

Brief summary:

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

Acute Lymphoblastic Leukemia

Refractory Acute Lymphoblastic Leukemia

Study ID

NCT06847269

Start date

May 21, 2025

Status verified date

Mar, 2026

Completion date

Apr, 2031

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Autologous Apheresis and Manufacturing

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Treatment

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Fludarabine

Given IV

Cyclophosphamide

Given IV

Mesna

Given IV

CD19-CAR T cell Infusion

Patients will receive the CD19-CAR T cells by vein, through either an IV or a central line.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Aimee Talleur, MD

8662785833referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Aimee Talleur, MD

866-278-5833referralinfo@stjude.org

Principal Investigator:

Aimee Talleur, MD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-03-25.