Large B Cell LymphomaPhase 1NCT07478848
Radiation, Oral Vancomycin, and CAR-T for B-Cell Lymphomas
A Phase 1 study testing Vancomycin 125mg, Radiation Therapy and CAR-T in people with Large B Cell Lymphoma and Non Hodgkin Lymphoma (NHL), run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large B Cell Lymphoma, Non Hodgkin Lymphoma (NHL), Diffuse Large B Cell Lymphoma (DLBCL)
- What is being tested?
- Vancomycin 125mg, Radiation Therapy and CAR-T
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2026to 1 Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Megan Jones, MPH contact
United States1 site, 1 recruiting
- Recruiting
Abramson Cancer Center, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Brittany Koch, 215-615-5858, brittany.koch@pennmedicine.upenn.edu
About this study
Official title: A Pilot Trial of Bridging Radiation Therapy With Oral Vancomycin for Patients With B-cell Lymphomas Undergoing CAR-T Therapy
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
- Being tested
- Vancomycin 125mg, Radiation Therapy, CAR-T
- Keywords
- non-hodgkin lymphoma, NHL, large B cell lymphoma, DLBCL, diffuse large B cell lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin 125mgDrug
oral
Radiation TherapyRadiation
Radiation Therapy
CAR-TBiological
standard of care anti-CD19 CAR-T
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Vancomycin 125mg; Radiation: Radiation Therapy; Biological: CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine release syndrome
rate of CART-related cytokine release syndrome
Measured: date of CAR-T infusion to 28 days after infusion
Severe adverse events
rate of grade ≥ 3 adverse events attributed to vancomycin or radiation
Measured: CAR-T infusion to 28 days after infusion
VRE
rate of vancomycin-related enterococcus
Measured: start of vancomycin to day 28 after CAR-T infusion
Adverse Events
rate of adverse events (AEs) and serious adverse events (SAEs)
Measured: start of vancomycin until day 28 after CAR-T infusion
Secondary outcomes (2)
Best overall response rate
percentage of all patients who receive CAR-T and have complete response and partial response after CAR-T
Measured: CAR-T infusion to 12 months after CAR-T infusion
Complete response rate
percentage of patients treated with CAR-T who have a complete response
Measured: CAR-T infusion to 12 months after CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start29 May 2026
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elise Chong, MD, Principal investigator, Abramson Cancer Center, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478848
- Sponsor's protocol ID
- UPCC 69425
- Other IDs
- 858761
- Status last verified
- Jun 2026
- First submitted
- 3 Mar 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Bridging Radiation Therapy With Oral Vancomycin for Patients With B-cell Lymphomas Undergoing CAR-T Therapy
- ClinicalTrials.gov ID
- NCT07478848
- Acronym / sponsor ID
- UPCC 69425
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 May 2026 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vancomycin, radiation therapy, and CAR-T | Experimental | Drug: Vancomycin 125mg, Radiation: Radiation Therapy, Biological: CAR-Tvancomycin 125 mg orally four times per day, followed by standard of care radiation and standard of care CD19 CAR T-cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vancomycin 125mgoral | Drug | vancomycin, radiation therapy, and CAR-T |
| Radiation TherapyRadiation Therapy | Radiation | vancomycin, radiation therapy, and CAR-T |
| CAR-Tstandard of care anti-CD19 CAR-T | Biological | vancomycin, radiation therapy, and CAR-T |
Primary outcome
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)
2 secondary outcomes
Best overall response rate
Time frame: CAR-T infusion to 12 months after CAR-T infusion
Complete response rate
Time frame: CAR-T infusion to 12 months after CAR-T infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megan Jones, MPH contact
Elise Chong, MD principal investigator
Abramson Cancer Center, University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vancomycin 125mg, Radiation Therapy and CAR-T in people with Large B Cell Lymphoma and Non Hodgkin Lymphoma (NHL), run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Lundberg, PA-C (215-615-5858, rachel.lundberg@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine release syndrome (time frame: date of CAR-T infusion to 28 days after infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.