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NCT06847269 | RECRUITING | Acute Lymphoblastic Leukemia

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

St. Jude Children's Research Hospital

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.

Condition or disease

Acute Lymphoblastic Leukemia

Refractory Acute Lymphoblastic Leukemia

Intervention/treatment

Fludarabine

Cyclophosphamide

Mesna

CD19-CAR T cell Infusion

Phase

PHASE2

Detailed Description:

CAR19PK is a Phase II study evaluating lymphodepleting chemotherapy (age-based fludarabine dosing and cyclophosphamide), followed by infusion of CD19-CAR T cells, in pediatric and young adult patients ≤ 21 years old with relapsed/refractory CD19-positive leukemia. Treatment will include a single course of lymphodepleting chemotherapy followed by CAR T cell infusion. Lymphodepletion will include fludarabine (dosing based on age) and cyclophosphamide. The CAR T cell infusion will include a single infusion of 3x10\^6 CD19-CAR T cells/kg patient weight. This protocol contains a two-part consent process: 1) to proceed with autologous apheresis and 2) to proceed with treatment with lymphodepleting chemotherapy and infusion of the CD19-CAR T cell product.

Study Type : INTERVENTIONAL
Estimated Enrollment : 25 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia: An Investigation of Lymphodepleting Chemotherapy Pharmacokinetics
Actual Study Start Date : 2025-08
Estimated Primary Completion Date : 2030-03
Estimated Study Completion Date : 2031-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: to 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
    • CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia

    Location Details

    NCT06847269

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, Tennessee

    St. Jude Children's Research Hospital

    Memphis, Tennessee, United States, 38105