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

NCT07478848 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: UPCC 69425858761
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

non-hodgkin lymphoma; NHL; large B cell lymphoma; DLBCL; diffuse large B cell lymphoma

Outcome Measures

Primary Outcomes (4)

• Cytokine release syndrome

  rate of CART-related cytokine release syndrome

  date of CAR-T infusion to 28 days after infusion

• Severe adverse events

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

  CAR-T infusion to 28 days after infusion

• VRE

  rate of vancomycin-related enterococcus

  start of vancomycin to day 28 after CAR-T infusion

• Adverse Events

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

  start of vancomycin until day 28 after CAR-T infusion

Secondary Outcomes (2)

• Best overall response rate

  CAR-T infusion to 12 months after CAR-T infusion

• Complete response rate

  CAR-T infusion to 12 months after CAR-T infusion

Study Arms (1)

vancomycin, radiation therapy, and CAR-T

EXPERIMENTAL

vancomycin 125 mg orally four times per day, followed by standard of care radiation and standard of care CD19 CAR T-cells

Drug: Vancomycin 125mg; Radiation: Radiation Therapy; Biological: CAR-T

Interventions

Radiation Therapy RADIATION

Radiation Therapy

vancomycin, radiation therapy, and CAR-T

Vancomycin 125mg DRUG

oral

vancomycin, radiation therapy, and CAR-T

CAR-T BIOLOGICAL

standard of care anti-CD19 CAR-T

vancomycin, radiation therapy, and CAR-T

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Abramson Cancer Center, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse

Interventions

Vancomycin; Radiotherapy

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Therapeutics

Study Officials

• Elise Chong, MD

  Abramson Cancer Center, University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Lundberg, PA-C

CONTACT

215-615-5858; rachel.lundberg@pennmedicine.upenn.edu

Megan Jones, MPH

CONTACT

megan.jones1@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 18, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)