Radiation, Oral Vancomycin, and CAR-T for B-Cell Lymphomas (NCT07478848) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Radiation, Oral Vancomycin, and CAR-T for B-Cell Lymphomas
United States14 participantsStarted 2026-04-07
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ooph…
What they're measuring
1
Cytokine release syndrome
Timeframe: date of CAR-T infusion to 28 days after infusion
2
Severe adverse events
Timeframe: CAR-T infusion to 28 days after infusion
3
VRE
Timeframe: start of vancomycin to day 28 after CAR-T infusion
4
Adverse Events
Timeframe: start of vancomycin until day 28 after CAR-T infusion