NCT05252403

Residual Disease Driven Strategy for CARCIK (CD19) in Adults/Pediatric BCP-ALL

Measurable Residual Disease Driven Strategy for One or Two Infusions of Non- Viral, Transposon-manipulated CARCIK (CD19) Cells: A Phase II Study in Pediatric and Adult Patients With Relapsed/Refractory B Cell Precursor ALL (BCP-ALL)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Fondazione Matilde Tettamanti Menotti De Marchi Onlus · Academic / Other
• Sex: All
• Age: 1 Year – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open-label, multi-center, phase II study to determine the activity and the safety of a therapeutic strategy that allows a second CARCIK-CD19 cells infusion, driven by the status of disease from one month after the first infusion, in adult and pediatric patients with r/r BCP- ALL.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
GENETIC	PTG-CARCIK-CD19	PTG-CARCIK-CD19 cells is a gene therapy medicinal product (GTMP) composed of genetically modified allogeneic T lymphocytes formulated as cell suspension in normal saline solution and freezing media

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-12-01
• Completion: 2025-03-01
• First posted: 2022-02-23
• Last updated: 2023-05-06

Locations

2 sites across 1 country: Italy