Radiation, Oral Vancomycin, and CAR-T for B-Cell Lymphomas

This study is looking at whether it's practical and safe to combine radiation therapy and an oral antibiotic called vancomycin (125mg) before giving standard CAR-T cell therapy for people with large B-cell lymphomas. CAR-T cell therapy uses your own immune cells, specially modified to fight cancer. The study will enroll about 14 adults (18 years or older) who have B-cell lymphoma and are planning to receive CAR-T therapy. We want to see how often side effects like cytokine release syndrome (a common reaction to CAR-T therapy) and severe adverse events occur, and if a specific type of bacteria (VRE) is present. The study's current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 14 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor for cytokine release syndrome and severe adverse events for 28 days after CAR-T infusion. VRE will be measured from the start of vancomycin to 28 days after CAR-T infusion.

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NCT07478848

Radiation, Oral Vancomycin, and CAR-T for B-Cell Lymphomas

Recruiting
PHASE1Ages 18+InterventionalTreatment
Abramson Cancer Center at Penn Medicine
~14 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Vancomycin 125mgRadiation TherapyCAR-T

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cytokine release syndrome
Measured over date of CAR-T infusion to 28 days after infusion
+3 more outcomes measured
Large B Cell Lymphoma
Non Hodgkin Lymphoma (NHL)
Diffuse Large B Cell Lymphoma (DLBCL)
Diffuse Large B Cell Lymphoma Refractory
Diffuse Large B Cell Lymphoma Relapsed
1 sites across 1 states
Pennsylvania1
  • Elise Chong, MD · PRINCIPAL_INVESTIGATOR · Abramson Cancer Center, University of Pennsylvania

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Eligibility criteria

Inclusion

Male or female subject aged ≥ 18 years.
Pathologically confirmed B-cell lymphoma patients intended for standard of care CAR-T
ECOG Performance Status ≤ 2.
Subjects must be clinically eligible to receive standard of care anti-CD19 CAR-T
Subjects must have at least one site of disease amenable to radiation, with the ability to deliver radiation to at least 50% of involved sites
Subjects must have at least one site of measurable disease based on CT or FDG PET
Subjects must not be anticipated to require additional therapy beyond bridging radiation listed in this protocol for control of their lymphoma
For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause.
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion

Unable to take oral vancomycin for any reason, including: Allergy or Inability to swallow drug
Known history of vancomycin resistant enterococcus (VRE)
Contraindications to radiation therapy, including scleroderma, systemic lupus erythematosus, Crohn disease, ulcerative colitis, or idiopathic pulmonary fibrosis
History of radiation pneumonitis or other grade 4 radiation-related adverse event
Prior or concurrent malignancy whose natural history or treatment which has the potential to interfere with the safety or efficacy assessment of the radiation therapy are eligible for this trial.
Severe, uncontrolled, significant intercurrent or recent illness that would exclude them from being a candidate for standard-of-care CART therapy.
Known uncontrolled HIV infection with a detectable viral load at the time of screening. Note: Patients on effective antiretroviral therapy or who will plan on going on antiretroviral therapy at the time of screening are eligible for this trial. HIV testing is not required for eligibility.
Active infection that required the use of antibiotics within 4 weeks prior to registration
Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures
  • Cytokine release syndromedate of CAR-T infusion to 28 days after infusion

    rate of CART-related cytokine release syndrome

  • Severe adverse eventsCAR-T infusion to 28 days after infusion

    rate of grade ≥ 3 adverse events attributed to vancomycin or radiation

  • VREstart of vancomycin to day 28 after CAR-T infusion

    rate of vancomycin-related enterococcus

  • Adverse Eventsstart of vancomycin until day 28 after CAR-T infusion

    rate of adverse events (AEs) and serious adverse events (SAEs)