New combo aims to boost CAR-T safety in lymphoma patients
NCT ID NCT07478848
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This early-stage trial tests whether giving radiation therapy and the antibiotic vancomycin before CAR-T cell therapy is safe and doable for people with large B-cell lymphoma. About 14 adults whose lymphoma has not responded or has come back will receive this combination. The goal is to see if this approach reduces side effects like cytokine release syndrome while still helping the CAR-T cells work.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 14 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Abramson Cancer Center, University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Proton beams vs. X-Rays: can a pricier radiation spare hearts and prevent second cancers?
- Can 'Memory-Enhanced' immune cells outsmart lymphoma?
- Can engineered immune cells lock in remission for aggressive lymphoma?
- Can a new immune cell therapy outsmart resistant blood cancers?
- Engineered immune cells take aim at Hard-to-Treat lymphomas
- Can a Two-Drug combo keep aggressive lymphoma at bay?