NCT04134117

Tisagenlecleucel In Primary CNS Lymphoma

Pilot Study of Tisagenlecleucel, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, in Patients With Primary Central Nervous System Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Matthew J. Frigault, M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, is researching the safety of tisagenlecleucel in participants with primary central nervous system lymphoma. . -The name of the study intervention is tisagenlecleucel.

Detailed description

This research study is a Pilot Study, which is the first time investigators are examining this intervention in people with primary central nervous system lymphoma. * The name of the study intervention is tisagenlecleucel. Tisagenlecleucel is an investigational treatment that uses the participants own immune cells, called T cells, to try to kill the cancerous cells * The research study procedures include screening for eligibility and study treatment including, leukapheresis, evaluations, and follow up visits. * The study treatment will be one day and participants will be followed for up to 2 years. * It is expected that about 12 people will take part in this research study

Conditions

• Primary CNS Lymphoma
• Refractory Primary CNS Lymphoma
• Relapsed Primary CNS Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Tisagenlecleucel	One time single predetermined dose level CAR-positive T cells will be utilized based on the FDA approved product label.

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-04-14
• Completion: 2022-04-14
• First posted: 2019-10-22
• Last updated: 2026-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study