NCT02650414

CD22 Redirected Autologous T Cells for ALL

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 1 Year – 29 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a single center, single arm, dual-cohort, open-label pilot study to determine the feasibility and safety of a single dose (administered as split fractions) of autologous T cells expressing CD22 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4- 1BB) co-stimulatory domains (referred to as "CART22" and "CART22-65s" cells) in pediatric patients with relapsed or refractory B-cell acute lymphoblastic leukemia. Cohort assignment will be dependent on the date of consent and confirmation of eligibility by a physician-investigator as follows: * Cohort 1: was closed to additional recruitment as of Protocol Version 8. All subjects who received CART22 cells will be retrospectively assigned to Cohort 1. * Cohort 2: was opened as of Protocol Version 8. All subjects assigned to Cohort 2 will receive CART22-65s cells given over 3 days. * Cohort 3: will open as of Protocol V12, with subjects enrolled sequentially after all infusion slots in Cohort 2 are filled. All subjects assigned to Cohort 3 will also receive CART22-65s cells, however the product will be administered over 2 days.

Conditions

• B Cell Leukemias
• B Cell Lymphomas

Interventions

Type	Name	Description
BIOLOGICAL	Cohort 1	Subjects \<50kg will receive 0.2-1 x 10\^7 CART22 cells/kg as a split dose over three days as follows: Day 1, 10% fraction: 0.2-1x10\^6 CART22 cells/kg Day 2, 30% fraction: 0.6-3x10\^6 CART22 cells/kg Day 3, 60% fraction: 1.2-6x10\^6 CART22 cells/kg Subjects ≥50kg will receive 1-5x10\^8 CART22 cells as a split dose over three days as follows: Day 1, 10% fraction: 1-5x10\^7 CART22 cells/kg Day 2, 30% fraction: 0.3-1.5x10\^8 CART22 cells/kg Day 3, 60% fraction: 0.6-3x10\^8 CART22 cells/kg
BIOLOGICAL	Cohorts 2	Subjects \<50kg will receive 0.2-1 x 10\^7 CART22-65s cells/kg as a split dose over three days as follows: Day 1, 10% fraction: 0.2-1x10\^6 CART22-65s cells/kg Day 2, 30% fraction: 0.6-3x10\^6 CART22-65s cells/kg Day 3, 60% fraction: 1.2-6x10\^6 CART22-65s cells/kg Subjects ≥50kg will receive 1-5x10\^8 CART22-65s cells as a split dose over three days as follows: Day 1, 10% fraction: 1-5x10\^7 CART22-65s cells/kg Day 2, 30% fraction: 0.3-1.5x10\^8 CART22-65s cells/kg Day 3, 60% fraction: 0.6-3x10\^8 CART22-65s cells/kg
BIOLOGICAL	Cohort 3	Subjects \<50kg will receive 0.2-1 x 10\^7 CART22-65s cells as a split dose over two days as follows: Day 1, 25% fraction: 0.5-2.5x10\^6 CAR T cells/kg Day 2, 75% fraction: 1.5-7.5x10\^6 CAR T cells/kg Subjects ≥50kg will receive 1-5x10\^8 CART22-65s cells as a split dose over two days as follows: Day 1, 25% fraction: 0.25-1.25x10\^8 CART22-65s cells Day 2, 75% fraction: 0.75-3.75x10\^8 CART22-65s cells

Timeline

• Start date: 2016-01-13
• Primary completion: 2037-12-01
• Completion: 2037-12-01
• First posted: 2016-01-08
• Last updated: 2025-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study