Actively Recruiting
A Feasibility Study of Bridging Radiation to All Sites of FDG-Avid Disease for Commercial CAR T-Cell Infusion in Patients With Large B-Cell Lymphoma
Led by City of Hope Medical Center · Updated on 2026-02-04
9
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the use of bridging radiation therapy given before chimeric antigen receptor (CAR) T-cell infusion to treat large B-cell lymphoma (LBCL) that has returned or not responded to prior treatments. This early phase I trial focuses on patients with relapsed or refractory LBCL, a group with historically poor outlooks. CAR T-cell therapy involves modifying a patient's immune cells to target and attack cancer cells, but during the time between cell collection and infusion, disease symptoms may worsen. Bridging radiation aims to control disease and symptoms during this critical period before CAR T-cell infusion. Participants undergo leukapheresis to collect T-cells, followed by external beam radiation therapy to all sites of active disease identified by PET scans. After radiation, patients receive commercial CAR T-cell infusion as standard care. Imaging with PET/CT and possibly MRI is done throughout the study to monitor disease. Blood samples are collected multiple times for immune profiling and other analyses. The study uses the RefleXion X1 linear accelerator for radiation and tracks responses and side effects. During the study, patients have regular scans and blood tests to assess disease control, treatment response, and side effects up to one year after CAR T-cell infusion. Researchers measure how many complete the planned radiation therapy and evaluate outcomes like progression-free survival, overall survival, and local and distant disease control. The study involves about 3 months of treatment preparation and follows patients for safety and treatment effectiveness for up to one year.
CONDITIONS
Brief 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...
- Provide documented informed consent and assent when appropriate
- Be 18 years of age or older
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less or Karnofsky Performance Status of 60 or higher
- Have histologically confirmed large B-cell lymphoma
- Have relapsed or refractory disease
- Planned to receive commercial CAR T-cell infusion within 3 months of enrollment
- Have 6 or fewer sites of FDG-PET active disease treatable with a maximum of 3 radiation isocenters
- Have measurable disease of at least 1.5 cm on CT or MRI or by RECIST 1.1 criteria
- Be fully recovered from acute toxic effects of prior anti-cancer therapy except alopecia, to grade 1 or less
- Women of childbearing potential must have a negative pregnancy test within 30 days prior to starting protocol therapy
You will not qualify if you...
- Prior CD19-directed therapy
- Radiation therapy within 21 days before starting protocol therapy
- Presence of central nervous system disease
- History of allergic reactions to compounds similar to the study agent
- Active diarrhea
- Clinically significant uncontrolled illness
- Active infection requiring antibiotics
- Presence of other active malignancy
- Pregnant females
- Any condition that contraindicates participation due to safety concerns
- Inability to comply with study procedures or logistics as judged by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - From the first fraction of radiation until approximately 1 month after CAR T-cell infusion
Participants receive leukapheresis, undergo external beam radiation therapy to all sites of FDG-avid disease, and receive CAR T-cell infusion per standard of care.
Multiple visits for leukapheresis, radiation therapy sessions, and CAR T-cell infusion
Duration - Up to 1 year after CAR T-cell infusion
Participants undergo PET/CT imaging and blood sample collection throughout the study to monitor response and safety for up to 1 year after treatment.
Regular imaging and blood sample collection visits during follow-up
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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