NCT04534634

Study of IFN-α Combined With CAR-T Cell Therapy in Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL）

An Open-label, Phase 2, Single-Center Study to Assess the Efficacy and Safety of Interferon-α Combined With Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of IFN-α combined with CAR-T cell therapy in relapsed and refractory acute lymphoblastic leukemia (R/R ALL).

Detailed description

This is a phase 2, single-center study. The patients will receive IFN-α combined with infusion of CAR T-cells in R/R B-ALL patients. The study participation will be 5 years including treatment and follow-up periods.

Conditions

• B-cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
COMBINATION_PRODUCT	IFN-α combined with CAR-T cell therapy	Adults: 14 daily intramuscular injections 300 million IU of Interferon-α for a 28-day cycle. Children: 14 daily intramuscular injections 200mg/m\^2 of Interferon-α for a 28-day cycle. CAR T cell: (1-2)×10\^7/kg, intravenously infusion.

Timeline

• Start date: 2019-04-01
• Primary completion: 2023-07-31
• Completion: 2025-07-31
• First posted: 2020-09-01
• Last updated: 2020-09-01

Locations

1 site across 1 country: China