NCT05574114

A Study of Radiation Therapy Before CAR T Cell Therapy for People With B Cell Lymphoma

A Phase I Study Of Split-Course Bridging Radiotherapy (SC-BRT) Prior To Commercial CD19 CAR T-Cell Therapies For Patients With Relapsed or Refractory B-Cell Lymphomas

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test whether radiation therapy given before standard CAR T cell therapy is a safe and effective treatment for people with relapsed and refractory B cell lymphoma. The researchers will also study whether radiation therapy used in this study is a practical treatment option before standard CAR T cell therapy.

Conditions

• Non-Hodgkin Lymphoma
• Non-Hodgkin's Lymphoma, Relapsed
• Non-Hodgkin's Lymphoma Refractory

Interventions

Type	Name	Description
RADIATION	Bridging radiotherapy (BRT)	RT Part I. The target will be to complete the 9th fraction of radiotherapy (i.e., total of 27Gy) between days -12 and -8 Day -2: BRT Part II (intervention is one fraction 3 Gy to receive a total dose of 3 Gy).
DRUG	Conditioning chemotherapy	Day -5 to -3: Patients will receive standard of care lymphodepleting chemotherapy
BIOLOGICAL	CAR T-cell product	Day 0: Subject will receive standard of care infusion of a manufactured commercial CAR T-cell product.

Timeline

• Start date: 2022-10-05
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2022-10-10
• Last updated: 2025-11-04

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study