Pilot Study of Autologous Anti-CD22 Chimeric Antigen Receptor Redirected T Cells in Pediatric Patients With Chemotherapy Resistant Or Refractory Acute Lymphoblastic Leukemia

NCT02650414 Phase 1 ACTIVE_NOT_RECRUITING

This is a pilot study to determine the feasibility and safety of a single dose of autologous T cells expressing CD22 chimeric antigen receptors expressing tandem TCR-ζ and 4-1BB signaling domains (CART22/CART22-65s cells) in pediatric and young adult subjects with relapsed or refractory B cell acute lymphoblastic leukemia.

Details

Lead sponsor	University of Pennsylvania
Phase	Phase 1
Status	ACTIVE_NOT_RECRUITING
Enrolment	41
Start date	2016-01-13
Completion	2037-12

Conditions

• B Cell Leukemias
• B Cell Lymphomas

Interventions

• Cohort 1
• Cohorts 2
• Cohort 3

Primary outcomes

• Frequency and severity of adverse events, including, but not limited to, cytokine release syndrome (CRS) — From date of dosing ( day 1 ) up 15 years
  grade 3 and higher toxicity rate (toxicity possibly attributed to CART22)

Countries

United States