NCT07478848 Radiation, Oral Vancomycin, and CAR-T for B-Cell Lymphomas
| NCT ID | NCT07478848 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Abramson Cancer Center at Penn Medicine |
| Condition | Large B Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2026-05-29 |
| Primary Completion | 2029-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 14 participants in total. It began in 2026-05-29 with a primary completion date of 2029-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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
Contact & Investigator
Elise Chong, MD
PRINCIPAL INVESTIGATOR
Abramson Cancer Center, University of Pennsylvania
Frequently Asked Questions
Who can join the NCT07478848 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Large B Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07478848 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07478848 currently recruiting?
Yes, NCT07478848 is actively recruiting participants. Contact the research team at rachel.lundberg@pennmedicine.upenn.edu for enrollment information.
Where is the NCT07478848 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT07478848 clinical trial?
NCT07478848 is sponsored by Abramson Cancer Center at Penn Medicine. The principal investigator is Elise Chong, MD at Abramson Cancer Center, University of Pennsylvania. The trial plans to enroll 14 participants.