Bridging Radiation Before CAR T-Cell Therapy for Large B-Cell Lymphoma

This study is looking at a new approach for people with large B-cell lymphoma (LBCL) that has come back or hasn't responded to previous treatments. It's testing if giving radiation therapy before CAR T-cell therapy (a treatment where your own immune cells are specially trained to fight cancer) can be helpful. Researchers want to see if this combination is safe and can improve outcomes for patients. You might be able to join if you are 18 or older, have confirmed large B-cell lymphoma that has relapsed or is refractory, and meet certain health criteria. The main goal is to see how many participants can complete the planned radiation therapy. This study is currently unclear on its recruitment status and plans to enroll 9 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It is an early-phase study, not specified as a particular phase, and plans to enroll 9 participants.
What's involved
You would undergo leukapheresis (a procedure to collect your blood cells), receive external beam radiation therapy, and then CAR T-cell infusion. You would also have PET/CT scans and blood sample collections throughout the study.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured from the first fraction of radiation until approximately 1 month after CAR T-cell infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05800405

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
City of Hope Medical Center
~9 participants
Updated 2026-02-04 on ClinicalTrials.gov
What's tested:Biospecimen CollectionChimeric Antigen Receptor T-Cell TherapyComputed TomographyExternal Beam Radiation TherapyLeukapheresisMagnetic Resonance Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants completing planned radiation therapy
Measured over From the first fraction of radiation until approximately 1 month after infusion of chimeric antigen receptor (CAR) T-cell therapy
Recurrent Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma

NCT05800405

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope Medical Center

    Duarte, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Savita V Dandapani · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

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Eligibility criteria

Inclusion

Documented informed consent of the participant and/or legally authorized representative.
Assent, when appropriate, will be obtained per institutional guidelines.
Age: \>= 18 years.
Eastern Cooperative Oncology Group (ECOG) =\< 2 or Karnofsky Performance Status (KPS) \>= 60.
Histologically confirmed large B-cell lymphoma.
Relapsed/refractory disease.
Planned to undergo commercial CAR T-cell infusion within 3 months of enrollment.
6 or fewer sites (treatable with a maximum of 3 isocenters) of FDG-PET avid disease, treatable with a a maximum of 3 isocenters.
Measurable disease e.g., at least 1.5 cm on CT/MRI or by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1).
Fully recovered from the acute toxic effects (except alopecia) to =\< grade 1 to prior anti-cancer therapy.
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (performed within 30 days prior to day 1 of protocol therapy).
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Exclusion

Prior CD19-directed therapy.
Radiation therapy within 21 days prior to day 1 of protocol therapy.
Central nervous system (CNS) disease.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
Active diarrhea.
Clinically significant uncontrolled illness.
Active infection requiring antibiotics.
Other active malignancy.
Females only: Pregnant.
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
  • Proportion of participants completing planned radiation therapyFrom the first fraction of radiation until approximately 1 month after infusion of chimeric antigen receptor (CAR) T-cell therapy

    Will be assessed by the proportion of participants completing planned radiation therapy without any grade 3 or higher radiation-attributable (possibly, probably, or definitely) adverse events (AEs), along with its associated 95% Clopper Pearson exact binomial confidence interval (CI). All participants who start protocol radiation therapy are evaluable.