6 Participants NeededMy employer runs this trial

huCART19-IL18-eDHFR Cells for Follicular Lymphoma

AC
SS
Overseen ByStephen Schuster, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Pennsylvania
Must be taking: Anti-CD20 antibodies, Alkylating agents
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with follicular lymphoma that has returned or resisted previous therapies. Researchers use a special cell therapy called huCART19-IL18-eDHFR cells to assess its safety and effectiveness against cancer. The trial also explores a novel method to track these cells in the body using advanced imaging techniques. Individuals diagnosed with follicular lymphoma who have not responded to at least two prior treatments, including a specific antibody and chemotherapy, may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on systemic steroids, immunosuppressants, or antifolate chemotherapy like trimethoprim or methotrexate during the study.

Is there any evidence suggesting that huCART19-IL18-eDHFR cells are likely to be safe for humans?

Research has shown that huCART19-IL18-eDHFR cells have a good safety record from earlier studies. These cells are part of a CAR T-cell therapy, which uses specially modified immune cells to fight cancer. In studies with patients who have hard-to-treat lymphomas, the treatment was generally well tolerated, with most people not experiencing severe side effects. Some patients did experience side effects, but these were similar to those seen with other CAR T-cell therapies. This suggests that huCART19-IL18-eDHFR cells are about as safe as other treatments of this kind.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about huCART19-IL18-eDHFR cells because they bring a novel approach to treating follicular lymphoma. Unlike standard treatments like chemotherapy or monoclonal antibodies, this therapy uses genetically engineered T-cells that are designed to target and destroy cancer cells more effectively. The addition of IL-18 and eDHFR components aims to enhance the immune response and improve the persistence and activity of these engineered cells. This innovative mechanism of action has the potential to offer more effective and longer-lasting treatment outcomes for patients with this type of lymphoma.

What evidence suggests that huCART19-IL18-eDHFR cells might be an effective treatment for follicular lymphoma?

Research has shown that a new treatment using huCART19-IL18-eDHFR cells holds promise for treating lymphoma, even in patients unresponsive to other treatments. In this trial, participants will receive one of two different doses of these enhanced CAR T-cells, which are immune cells specially modified to better fight cancer. These cells have demonstrated an improved ability to survive and attack lymphoma cells. Notably, huCART19-IL18 has produced good results even at low doses. The treatment remains active in patients over time, suggesting it could continue to work and provide benefits. While more research is needed, these early findings suggest it could be a valuable option for people with relapsed or hard-to-treat follicular lymphoma.12367

Who Is on the Research Team?

SS

Stephen Schuster, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults (18+) with follicular lymphoma (grades 1-3A) that has come back or not responded after at least two treatments, including anti-CD20 antibody and an alkylating agent. Participants must have CD19 on their cancer cells, be in good physical condition, and not have active graft-versus-host disease.

Inclusion Criteria

I have signed the consent form.
I had my transplant more than 6 months ago.
I have been diagnosed with grade 1-3A follicular lymphoma.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single flat dose of huCART19-IL18-eDHFR cells and undergo PET/CT imaging

4 weeks
1 visit (in-person) for infusion, multiple visits for imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Regular follow-up visits

Long-term follow-up

Participants are monitored for long-term outcomes such as progression-free survival and overall survival

Up to 15 years

What Are the Treatments Tested in This Trial?

Interventions

  • huCART19-IL18-eDHFR cells

Trial Overview

The study tests a new CAR T-cell therapy called huCART19-IL18-eDHFR cells given as a single dose without prior immune system suppression. It also uses a special PET/CT scan to track these modified cells in the body using an imaging agent called [18F]Fluoropropyl-Trimethoprim.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Arm A - DL1Experimental Treatment2 Interventions
Group II: Arm A - DL-1Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Follicular Lymphoma Foundation

Collaborator

Citations

huCART19-IL18-eDHFR Cells in Relapsed/Refractory ...

This is a phase 1, open-label study to evaluate the feasibility, safety and preliminary efficacy of huCART19-IL18-eDHFR cells administered in patients with ...

huCART19-IL18: Enhancing CAR-T Cell Therapy for Blood ...

Enhanced CAR T-cells demonstrate improved effectiveness, survival and attacking abilities against lymphoma cells.

huCART19-IL18(University of Pennsylvania) - Drug ...

METHODS: In this study, we assessed the safety, feasibility, and preliminary efficacy of huCART19-IL18 in patients with relapsed or refractory lymphoma after ...

huCART19-IL18 / University of Pennsylvania

Enhanced CAR T-Cell Therapy for Lymphoma after Previous Failure. (PubMed, N Engl J Med) - P1 | "In this small study, huCART19-IL18 had a safety profile ...

Profile for The Follicular Lymphoma Foundation

This is a phase 1, open-label study to evaluate the feasibility, safety and preliminary efficacy of huCART19-IL18-eDHFR cells administered in patients with ...

huCART19-IL18 Is Tolerable, Induces Responses in CAR ...

Treatment with armored huCART19-IL18 was feasible, well tolerated, and elicited durable responses in patients with relapsed/refractory lymphomas.

Safety and efficacy of armored huCART19-IL18 in patients ...

Safety and efficacy of armored huCART19-IL18 in patients with relapsed/refractory lymphomas that progressed after anti-CD19 CAR T cells. Jakub Svoboda. Lymphoma ...