CD7-CAR-T Cells in Pediatric Relapsed/Refractory CD7+ T-ALL/LL

Required: CD7 overexpression (>98% CD7 expression on blast cells)

Diagnosis of CD7 expressing (> 98% CD7 expression on blast cells) T-ALL or LL

Must have received: standard frontline chemotherapy

Patients in 1st or subsequent relapse, after at least one standard frontline chemotherapy with BM involvement

Cannot have received: systemic steroids

Exception: inhaled/topical/non-absorbable steroids and physiologic replacement doses allowed if no increase in dose for at least 2 weeks prior to apheresis/infusion

Systemic steroids (at a dose equivalent to or greater than 2 mg/kg prednisone) in the 2 weeks before apheresis collection / Systemic steroids (at a dose > 2 mg/kg prednisone) in the 2 weeks before infusion

Cannot have received: systemic chemotherapy

Exception: no waiting period for patients relapsing on standard ALL maintenance chemotherapy

Systemic chemotherapy in the 2 weeks preceding apheresis collection / infusion

Cannot have received: nelarabine (nelarabine)

Nelarabine exposure in the 3 weeks preceding apheresis collection

Cannot have received: daratumumab (daratumumab)

daratumumab exposure in the 3 weeks preceding apheresis collection

Cannot have received: clofarabine (clofarabine)

clofarabine exposure in the 3 weeks preceding apheresis collection

Cannot have received: anti-thymocyte globulin (anti-thymocyte globulin, alemtuzumab)

Anti-thymocyte globulin (ATG) or Alemtuzumab (Campath®) in the 8 weeks preceding apheresis collection / infusion

Cannot have received: immunosuppressive agents

Immunosuppressive agents in the 2 weeks preceding apheresis collection / infusion

Cannot have received: radiation therapy

Radiation therapy must have been completed at least 2 weeks prior to apheresis / at least 3 weeks prior to enrollment

Cannot have received: anti-neoplastic investigational agents

Other anti-neoplastic investigational agents currently administered or within 30 days prior to apheresis / infusion