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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Vancomycin 125mg

    Drug

    oral

  • Radiation Therapy

    Radiation

    Radiation Therapy

  • CAR-T

    Biological/Vaccine

    standard of care anti-CD19 CAR-T

Treatment groups

14 Participants
are divided into 1 treatment group
Group A: vancomycin, radiation therapy, and CAR-TExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Cytokine release syndrome

rate of CART-related cytokine release syndrome

Time frame
date of CAR-T infusion to 28 days after infusion
2

Severe adverse events

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

Time frame
CAR-T infusion to 28 days after infusion
3

VRE

rate of vancomycin-related enterococcus

Time frame
start of vancomycin to day 28 after CAR-T infusion
4

Adverse Events

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

Time frame
start of vancomycin until day 28 after CAR-T infusion

Secondary outcomes

1

Best overall response rate

percentage of all patients who receive CAR-T and have complete response and partial response after CAR-T

Time frame
CAR-T infusion to 12 months after CAR-T infusion
2

Complete response rate

percentage of patients treated with CAR-T who have a complete response

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abramson Cancer Center at Penn Medicine

Lead sponsor

National Cancer Institute (NCI)

Collaborator