Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT06847269
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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT06847269
Study Brief:
Protocol Section:
NCT06847269