Recruiting
Early Phase 1

Bridging Radiation Therapy

Sponsor:

City of Hope Medical Center

Code:

NCT05800405

Conditions

Recurrent Diffuse Large B-Cell Lymphoma

Refractory Diffuse Large B-Cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Chimeric Antigen Receptor T-Cell Therapy

Computed Tomography

External Beam Radiation Therapy

Leukapheresis

Study Details

Brief summary:

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

Recurrent Diffuse Large B-Cell Lymphoma

Refractory Diffuse Large B-Cell Lymphoma

Study ID

NCT05800405

Start date

Jul 20, 2023

Status verified date

Feb, 2026

Completion date

Jan 4, 2027

Anticipated

Primary completion date

Jan 4, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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).

Study Design

Enrollment

9 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (leukapheresis, external beam radiation, CAR-T)

Patients undergo leukapheresis per standard of care, undergo external beam radiation therapy, and undergo CAR T-cell infusion per standard of care on study. Patients undergo PET/CT throughout the study and may undergo MRI during screening. Patients also undergo blood sample collection throughout the study.

Interventions

Biospecimen Collection

Undergo blood sample collection

Chimeric Antigen Receptor T-Cell Therapy

Receive CAR-T per standard of care

Computed Tomography

Undergo PET/CT

External Beam Radiation Therapy

Undergo radiation therapy

Leukapheresis

Receive leukapheresis

Magnetic Resonance Imaging

Undergo MRI

Positron Emission Tomography

Undergo PET/CT

Primary outcome measure

  • Proportion of participants completing planned radiation therapy [ Time Frame: From the first fraction of radiation until approximately 1 month after infusion of chimeric antigen receptor (CAR) T-cell therapy ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Principal Investigator:

Savita V. Dandapani

More Information

Sponsor

City of Hope Medical Center

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-02-04.