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Low Dose Radiation as Bridging Therapy in Relapsed B-Cell Non-Hodgkin Lymphoma

NCT05621096 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-09-25

No results posted yet for this study

Summary

The goal of this clinical trial is to learn about treatment for people with B-cell lymphoma that did not respond to treatment or that has gotten worse after treatment. The aim of this trial is to answer the following questions:

* If it is realistic to give people radiation treatment before they receive a chimeric antigen receptor (CAR) T-cell treatment for their cancer
* If it is safe to give people radiation treatment before they receive a CAR T-cell treatment for their cancer

Conditions

  • DLBCL - Diffuse Large B Cell Lymphoma
  • High-grade B-cell Lymphoma
  • Follicular Lymphoma
  • Mediastinal Large B-cell Lymphoma
  • Indolent B-Cell Non-Hodgkin Lymphoma
  • Relapsed Non-Hodgkin Lymphoma
  • Refractory Non-Hodgkin Lymphoma

Interventions

RADIATION

Bridging radiation therapy

Days -20 to -7: Patients will receive 2 fractions of 2 gray (Gy) for a total of 4 Gy received.

BIOLOGICAL

Liso-cel

Day 0: Patients will receive an infusion of liso-cel CAR T-cell product. Prior to the liso-cell infusion (Days -5 to -3), patients will receive lymphodepleting chemotherapy using fludarabine 30mg/m2 and cyclophosphamide 300mg/m2 per institutional standard procedures.

RADIATION

Post-infusion radiation

Days 30 to 80: Patients eligible for post-infusion radiation will receive a total dose of up to 32 Gy.

Sponsors & Collaborators

Principal Investigators

  • Christopher R D'Angelo, MD · University of Nebraska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2025-01-20
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT05621096 on ClinicalTrials.gov