NCT04473937

Radiation Post-CAR T in Refractory Lymphoma

Radiation Therapy To Enhance CAR T Efficacy Early in Post-CAR T Cell Therapy Refractory Lymphoma: A Pilot Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is evaluating the safety and efficacy of using radiotherapy in participants who have refractory lymphoma shortly after receiving CAR T cell therapy (axicel or tisacel).

Detailed description

This research study is a Pilot Study, which is the first time investigators are examining this intervention after administration of CAR T cell therapy. This research study looks to systematically investigate the safety and efficacy of radiotherapy following CAR T cell therapy (axicel or tisacel) in refractory lymphoma. CAR T cell therapy involves genetically modifying T cells to target tumor cells for death. Radiotherapy is a standard treatment offered with refractory lymphoma and uses high-energy x rays, or particles, to destroy or damage cancer cells. Few have received CAR T cell therapy prior to radiation therapy and this study aims to gather more information on radiotherapy following CAR T cell therapy as a treatment option and its potential to improve participants immune system's response to cancer cells as well as its interaction with CAR T cell therapy to better treat refractory lymphoma. The research study procedures include screening for eligibility, enrollment, biopsy following radiation, post-treatment period, and long-term follow-up. * Participants will receive radiotherapy at a dose and schedule determined by the study doctor. * Participants will be followed for up to 24 months after completion of study treatment. It is expected that about 20 people will take part in this research study.

Conditions

• Hematologic Malignancy
• Refractory Lymphoma

Interventions

Type	Name	Description
RADIATION	Radiotherapy	Radiotherapy at pre-determined dose and schedule

Timeline

• Start date: 2021-01-05
• Primary completion: 2021-10-09
• Completion: 2023-07-03
• First posted: 2020-07-16
• Last updated: 2025-09-24
• Results posted: 2024-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study