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

NCT06847269 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CAR19PK
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Fludarabine Pharmacokinetics

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

  Days -5, -4 and -3

Study Arms (1)

CAR19PK Therapy

EXPERIMENTAL

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.

Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Mesna; Biological: CD19-CAR T cell Infusion

Interventions

Fludarabine DRUG

Given IV

CAR19PK Therapy

Cyclophosphamide DRUG

Given IV

CAR19PK Therapy

Mesna DRUG

Given IV

CAR19PK Therapy

CD19-CAR T cell Infusion BIOLOGICAL

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

CAR19PK Therapy

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• CD19+ leukemia\*\* with any of the following:
• Refractory disease (primary or in relapse)
• nd or greater relapse
• Any relapse after allogeneic hematopoietic cell transplantation
• st 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

fludarabine; Cyclophosphamide; Mesna

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids

Study Officials

• Aimee Talleur, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aimee Talleur, MD

CONTACT

8662785833; referralinfo@stjude.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: May 21, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): April 1, 2031
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available at the time of article publication.
• Access Criteria: Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.

Locations

US (1)