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

NCT06104592 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-03-31

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Kite, A Gilead Company

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Michael Jain, MD, PhD · Moffitt Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-08
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06104592 on ClinicalTrials.gov