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CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia
Bu Faz 1 (Phase 1) çalışma, 21 yaş ve altındaki çocuklarda nükseden veya dirençli CD19 ve/veya CD22 pozitif akut lösemide, hastanın kendi hücrelerinden üretilen CD19-CD22-CAR T hücrelerinin güvenlik profilini belirlemeyi ve Faz 2 için önerilen dozu saptamayı amaçlıyor. Hücre infüzyonu öncesinde fludarabin, siklofosfamid ve mesna kullanılıyor. İkincil olarak tedavinin lösemi üzerindeki etkisi değerlendiriliyor; katılım için ikinci veya daha sonraki nüks gibi ölçütler aranıyor.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Collection and Manufacturing Eligibility Inclusion Criteria: * Age \<21 years old * Relapsed/refractory CD19- and/or CD22-positive acute leukemia defined as: \*CD19 and/or CD22-positivity confirmed within 2 months and after receipt of any CD19 or CD22-directed therapy * Second or greater relapse * Any relapse after allogeneic HCT * Refractory disease (primary or in relapse) despite therapy designed to induce remission * Estimated life expectancy of \> 12 weeks * Karnofsky or Lansky (age-dependent) performance score ≥50 (Appendix A) * For females of childbearing age: * Not lactating with intent to breastfeed * Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment Exclusion Criteria: * Known primary immunodeficiency * Known HIV positivity * Known contraindication to receiving protocol defined lymphodepleting * chemotherapy regimen * History of hypersensitivity reaction to murine protein-containing products Treatment Eligibility Inclusion Criteria: * Age \< 21 years old * Detectable disease in the bone marrow * Estimated life expectancy of \> 8 weeks * Karnofsky or Lansky (age-dependent) performance score \> 50 (Appendix A) * 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 \>50 mL/min/1.73m2 (GFR \>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 * 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 * Prior to planned CAR T cell infusion, patients with a history of prior allogeneicHCT must be at least 3 months from HCT, have no evidence of acute GVHD, and have not received a donor lymphocyte infusion (DLI) within the 28 daysprior to planned infusion * For females of childbearing age: * Not lactating with intent to breastfeed * Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment * If sexually active, agreement to use birth control until 3 months after T cell infusion. Male partners should use a condom. Exclusion Criteria: * Known primary immunodeficiency * Known HIV positivity * Known contraindication to receiving protocol defined lymphodepleting * chemotherapy regimen * History of hypersensitivity reactions to murine protein-containing products * Severe, uncontrolled bacterial, viral or fungal infection * Active CNS-3 disease * Evidence of active, uncontrolled neurologic disease