NCT07478848 · Abramson Cancer Center at Penn Medicine
Radiation, Oral Vancomycin, and CAR-T for B-Cell Lymphomas
What this study is about
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
View original scientific description
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
Interventions
DRUG
Vancomycin 125mg
oral
RADIATION
Radiation Therapy
Radiation Therapy
BIOLOGICAL
CAR-T
standard of care anti-CD19 CAR-T
Primary outcome measures
Cytokine release syndrome
Time frame: date of CAR-T infusion to 28 days after infusion
rate of CART-related cytokine release syndrome
Severe adverse events
Time frame: CAR-T infusion to 28 days after infusion
rate of grade ≥ 3 adverse events attributed to vancomycin or radiation
VRE
Time frame: start of vancomycin to day 28 after CAR-T infusion
rate of vancomycin-related enterococcus
Adverse Events
Time frame: start of vancomycin until day 28 after CAR-T infusion
rate of adverse events (AEs) and serious adverse events (SAEs)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. The following age-specific requirements apply: Women \< 50 years of age: amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or Underwent surgical sterilization (bilateral oophorectomy or hysterectomy). Women ≥ 50 years of age: amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or had radiation-induced menopause with last menses \>1 year ago; or had chemotherapy-induced menopause with last menses \>1 year ago; or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
- 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 criteria
- 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
Where
- Philadelphia, Pennsylvania
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations