NCT03620058

CART22 Alone or in Combination With huCART19 for ALL

Phase 1 Study of Autologous Anti-CD22 Chimeric Antigen Receptor Redirected T Cells (CART22-65s) Alone and When Co-administered With Humanized Anti-CD19 Chimeric Antigen Receptor Redirected T Cells (huCART19) In Patients With Chemotherapy Resistant Or Refractory Acute Lymphoblastic Leukemia

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, open-label, phase 1 study to determine the safety and feasibility of infusing CART22-65s with or without huCART19 after administration of lymphodepleting chemotherapy in adult patients with relapsed or refractory B-ALL.

Conditions

• Chemotherapy Resistant Acute Lymphoblastic Leukemia
• Refractory Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	CART22-65s cells	Autologous T cells transduced with a lentiviral vector to express anti-CD22 scFv TCRz:41BB
BIOLOGICAL	huCART19 Cells	Autologous T cells transduced with lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB

Timeline

• Start date: 2018-09-27
• Primary completion: 2036-01-01
• Completion: 2036-01-01
• First posted: 2018-08-08
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study