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RECRUITING
NCT06104592
PHASE2

Single-Arm Comprehensive Ablative Bridging Irradiation I Prior to CD19 CAR-T In High-Risk R/R LBCL

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

Summary

This is a phase 2, single-arm, open-label study to evaluate the safety and efficacy of comprehensive bridging radiation therapy prior to CD19 CAR T-cell therapy for large B-cell lymphoma patients with bulky disease, defined as any lesion ≥5 cm.

Official title: Phase 2, Single-Arm Trial of Comprehensive Ablative Bridging Irradiation (CABI) Prior to CD19 CAR-T Cell Therapy in High-Risk, Relapsed or Refractory Large B Cell Lymphoma in Patients With Bulky Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2023-11-08

Completion Date

2026-12

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

RADIATION

Comprehensive Ablative Bridging Irradiation (CABI)

Participants will receive radiation therapy to all pretreatment lesions that are able to be feasibly and safely treated.

BIOLOGICAL

Chimeric Antigen Receptor T-Cell Therapy

Yascarta is an autologous anti-CD19 CAR T cell therapy manufactured from the patient's own T cells, which have been extracted and then reprogrammed with CAR molecules to help the T cells recognize cancer cells. The reengineered T cells are infused back into the patient to attack the cancer.

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States