CAR T-Cell Therapy for Non-Hodgkin's Lymphoma

Overseen By Vanderbilt-Ingram Service for Timely Access

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Vanderbilt-Ingram Cancer Center

Must not be taking: Immunomodulating agents

Disqualifiers: HIV, Hepatitis B/C, CNS disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

We hope to demonstrate that YESCARTA can be safely administered in the outpatient setting if we closely monitor subjects with physical exams, wearable devices, and telemedicine visits and only admit those who meet specified criteria

Research Team

Olalekan Oluwole, MD

Principal Investigator

Vanderbilt-Ingram Cancer Center

Eligibility Criteria

This trial is for adults over 18 with large B cell lymphoma or transformed follicular lymphoma that's relapsed after two therapies, including anthracycline and CD20-targeted therapy. Participants need good organ function, a caregiver to help monitor their health, and the ability to use telemedicine tools. They can't join if they've had prior CAR T-cell therapy, certain infections like HIV or hepatitis, CNS lymphoma involvement, severe allergies to study drugs, are pregnant/breastfeeding without birth control measures in place, have autoimmune diseases requiring treatment within the last 2 years or other conditions that might interfere with the study.

Inclusion Criteria

I can stay near Vanderbilt for treatments.

My large B cell lymphoma or transformed follicular lymphoma has not responded well to at least two previous treatments including an anthracycline and a CD20-targeted therapy.

A caregiver who can be educated to operate equipment for vital signs monitoring

Exclusion Criteria

Any medical condition likely to interfere with assessment of safety or efficacy of study treatment

I have an autoimmune disease that has caused organ damage or needed strong medication in the last 2 years.

Unlikelihood to complete all protocol-required study visits or procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Participants receive cyclophosphamide and fludarabine IV on days -5 to -3

1 week

3 visits (in-person)

Treatment

Participants receive YESCARTA IV infusion and are monitored closely in the outpatient setting

6 weeks

Daily monitoring with telemedicine and wearable devices

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Weekly visits (in-person)

Treatment Details

Interventions

• YESCARTA

Trial Overview The trial tests whether YESCARTA CAR T-cell therapy can be safely given outside of a hospital by using close monitoring through physical exams, wearable devices for vital signs tracking and telemedicine support. Patients will only be admitted if they meet specific criteria indicating more intensive care is needed.

Participant Groups

Group I: YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting Experimental Treatment 7 Interventions

Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.

Who Is Running the Clinical Trial?

Vanderbilt-Ingram Cancer Center

Lead Sponsor

Trials

221

Recruited

64,400+

Kite, A Gilead Company

Industry Sponsor

Trials

45

Recruited

4,300+