This clinical trial assesses whether it is feasible to use radiation therapy with vancomycin prior to CAR T-cell therapy for patients with large B-cell lymphomas
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
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
Single group
Vancomycin 125mg
Drugoral
Radiation Therapy
RadiationRadiation Therapy
CAR-T
Biological/Vaccinestandard of care anti-CD19 CAR-T
Cytokine release syndrome
rate of CART-related cytokine release syndrome
Severe adverse events
rate of grade ≥ 3 adverse events attributed to vancomycin or radiation
VRE
rate of vancomycin-related enterococcus
Adverse Events
rate of adverse events (AEs) and serious adverse events (SAEs)
Best overall response rate
percentage of all patients who receive CAR-T and have complete response and partial response after CAR-T
Complete response rate
percentage of patients treated with CAR-T who have a complete response
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Abramson Cancer Center at Penn Medicine
Lead sponsor
National Cancer Institute (NCI)
Collaborator
