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

Launched by ST. JUDE CHILDREN'S RESEARCH HOSPITAL · Feb 21, 2025

Keywords

ClinConnect Summary

This clinical trial, called CAR19PK, is studying a new treatment for young patients (up to 21 years old) with a type of leukemia called CD19-positive leukemia, which can be difficult to treat when it doesn’t respond to standard therapies. The researchers want to see how effective a treatment called CAR T cell therapy is, which works by using modified immune cells to attack the cancer. Before the CAR T cells are given, patients will receive a type of chemotherapy to help their bodies accept these modified cells better. The study will look at different doses of this chemotherapy, how long the CAR T cells stay active in the body, and what side effects might occur.

To participate in the trial, patients must have specific types of leukemia that are either not responding to treatment or have come back after treatment. They also need to be generally healthy, with a life expectancy of at least 12 weeks. Other important factors include age and certain health conditions. If eligible, participants can expect to receive close medical care and monitoring throughout the study to track their health and how well the treatment is working. This trial is not yet recruiting participants, but it aims to provide valuable information for treating challenging cases of leukemia in young people.

Gender

ALL

Eligibility 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