CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia
Recruiting now · Phase 2
Conditions studied: Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia
In brief
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.
Key facts
- Study ID
- NCT06847269
- Run by
- St. Jude Children's Research Hospital
- People needed
- 25
- Starts
- 2025-05-21
- Expected to finish
- 2031-04-01
- Last updated by the study team
- 2026-03-25
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
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
- 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
Where it is running
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
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