Actively Recruiting
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
Eligibility Criteria
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.
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.
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
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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