Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT05800405

Evaluation of Bridging Radiation Therapy Before CAR T-Cell Infusion for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma

Led by City of Hope Medical Center · Updated on 2026-02-04

9

Participants Needed

1

Research Sites

180 weeks

Total Duration

On this page

Sponsors

C

City of Hope Medical Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This early phase I clinical trial evaluates bridging radiation therapy given before chimeric antigen receptor (CAR) T-cell infusion to treat large B-cell lymphoma (LBCL) that has come back (relapsed) or has not responded to previous treatment (refractory). Patients with relapsed or refractory disease have historically poor prognosis. CAR T-cell therapy is a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood (leukapheresis). Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T-cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. While the outcomes from CAR T-cell therapy appear favorable, in the time between leukapheresis and CAR T-cell infusion many patients have symptomatic or life-threatening disease which often requires bridging therapy. Bridging therapy aims to slow disease progression and control symptoms during this critical period prior to CAR T-cell infusion. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells. Giving bridging radiation therapy to patients with relapsed or refractory LBCL prior to CAR T-cell infusion may improve treatment outcomes with minimal toxicity.

CONDITIONS

Official Title

Evaluation of Bridging Radiation Therapy Before CAR T-Cell Infusion for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided documented informed consent.
  • Age 18 years or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less or Karnofsky Performance Status (KPS) of 60 or higher.
  • Histologically confirmed large B-cell lymphoma.
  • Disease that is relapsed or refractory.
  • Planned to receive commercial CAR T-cell infusion within 3 months of enrollment.
  • 6 or fewer sites of FDG-PET avid disease treatable with up to 3 radiation isocenters.
  • Measurable disease at least 1.5 cm by CT/MRI or RECIST 1.1 criteria.
  • Fully recovered from acute toxic effects of prior cancer therapy except alopecia, with toxicity grade 1 or less.
  • Women of childbearing potential must have a negative pregnancy test within 30 days prior to starting treatment.
Not Eligible

You will not qualify if you...

  • Prior treatment with CD19-directed therapy.
  • Radiation therapy within 21 days before starting protocol therapy.
  • Presence of central nervous system (CNS) disease.
  • History of allergic reactions to compounds similar to the study agent.
  • Active diarrhea.
  • Clinically significant uncontrolled illness.
  • Active infection requiring antibiotics.
  • Presence of another active malignancy.
  • Pregnant females.
  • Any condition that the investigator judges would make participation unsafe.
  • Inability or unwillingness to comply with study procedures as judged by the investigator.

AI-Screening

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Trial Site Locations

Total: 1 location

1

City of Hope Medical Center

Duarte, California, United States, 91010

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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