CAR T cell therapy for young patients with CD19-positive leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of CAR T cell therapy combined with lymphodepleting chemotherapy in treating pediatric, adolescent, and young adult patients with refractory or relapsed CD19-positive leukemia. Participants will undergo a single course of chemotherapy using age-based doses of fludarabine and cyclophosphamide, followed by an infusion of modified T cells designed to target cancer cells. The study aims to assess the optimal dosing of chemotherapy, the persistence of CAR T cells in the body, and the overall effectiveness and safety of this treatment approach.

Why it matters

Who can join: the full rules

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

Where it's running

• St. Jude Children's Research Hospital
  Memphis, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Aimee Talleur, MD — St. Jude Children's Research Hospital
• Study coordinator: Aimee Talleur, MD
• Email: referralinfo@stjude.org
• Phone: 8662785833

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.