CAR T Cell Therapy for Brain Tumors

(IMPACT MET Trial)

TK
Overseen ByTaryn King, RN
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 aims to test the safety of a new CAR T cell therapy for adults with brain tumors that have spread from another cancer. Researchers seek to determine the treatment's effectiveness for individuals with new or recurring tumors after previous treatments. It is best suited for those whose cancer has returned or progressed and who have confirmed CD70 (a specific protein) on their cancer cells. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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

The trial requires that you stop any investigational therapy before joining. If you're on chemotherapy or immunotherapy, you must stop at least 14 days before starting the trial. The protocol doesn't specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Earlier studies have tested a new treatment called IL-8 receptor-modified CD70 CAR T cell therapy to assess its safety and practicality. These studies focus on using this treatment for brain tumors in adults. So far, the treatment appears safe for patients. Researchers are exploring this therapy because it targets CD70, a protein found on some tumor cells.

Although this treatment remains in the early stages, CAR T cell therapies have already succeeded in treating some blood cancers. This success suggests potential safety, but more research is needed to confirm this for brain tumors. While side effects can occur, early trials are designed to monitor and manage them closely.12345

Why do researchers think this study treatment might be promising?

Most treatments for brain tumors, like surgery, radiation, and chemotherapy, aim to remove or kill tumor cells directly but can harm healthy cells too. Unlike these standard options, the IL-8 Receptor Modified Patient-Derived Activated CD70 CAR T Cell Therapy is unique because it uses the body’s own immune cells, specifically engineered to target and attack tumor cells with precision. This therapy modifies T cells to recognize a protein called CD70 on tumor cells, potentially improving their ability to distinguish cancerous cells from normal ones. Researchers are excited because this approach could lead to more targeted, effective treatments with fewer side effects, opening up new possibilities for patients with brain tumors.

What evidence suggests that IL-8 receptor-modified patient-derived activated CD70 CAR T cell therapy might be an effective treatment for brain tumors?

Research has shown that IL-8 receptor-modified CD70 CAR T cell therapy may help treat brain tumors, particularly those with the CD70 marker. In one study, these modified cells effectively targeted glioblastoma, a type of brain cancer. This therapy enhances the immune system's ability to locate and destroy cancer cells. Early research also suggests it could be promising for patients whose cancer has metastasized to the brain. Although more studies are needed, these findings offer hope for improved treatment outcomes. Participants in this trial will receive one of two dose levels of this therapy to evaluate its effectiveness and safety.16789

Who Is on the Research Team?

MR

Maryam Rahman, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for adults (18+) with brain metastases from cancer, who have a good performance status and confirmed CD70 on their tumor. Participants must have adequate organ function, not be pregnant or breastfeeding, and cannot have serious ongoing illnesses or recent chemo/immunotherapy.

Inclusion Criteria

KPS ≥ 70
Histological confirmation of primary cancers
Histologic confirmation of CD70 on primary tumor, lymph node, or BM biopsy
See 12 more

Exclusion Criteria

Pregnant or lactating women
I have an immunosuppressive disease or HIV.
I have ongoing moderate or severe side effects from previous cancer treatments.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Cell Collection and Standard of Care

Patients undergo cell collection for CAR T cell generation and receive standard-of-care chemoradiation

2-4 cycles

CAR T Cell Administration

A single dose of 8R-70CAR T cells is administered via IV injection

2-6 months after enrollment
Hospital stay for monitoring

Post-Infusion Monitoring

Patients are monitored for infusion-related toxicities and safety

2 weeks
Frequent visits within 1-hour drive of UF Health

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 15 years
Regular visits and phone follow-ups

What Are the Treatments Tested in This Trial?

Interventions

  • IL-8 Receptor Modified Patient-Derived Activated CD70 CAR T Cell Therapy

Trial Overview

The study tests a new CAR T cell therapy made from the patient's own immune cells, modified to better target brain tumors by adding an IL-8 receptor. The main goal is to see if this treatment is safe and possible in people with brain metastases.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: IL-8 receptor-modified patient-derived activated CD70 CAR T cellsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Citations

IL-8 Receptor Modified Patient-Derived Activated CD70 ...

This is a Phase I Study evaluating the safety and feasibility of IL-8 receptor-modified patient-derived activated CD70 CAR T cells in adult ...

NCT05353530 | IL-8 Receptor-modified CD70 CAR T Cell ...

This is a phase I study to assess the safety and feasibility of IL-8 receptor modified patient-derived activated CD70 CAR T cell therapy in CD70+ adult ...

CAR-T cell therapy for the treatment of adult high-grade gliomas

This review discusses the landscape of clinical trials for CAR-T cell therapy targeting brain tumors, highlighting key advancements like novel target antigens.

A comparative analysis of CD70-directed CAR-T cells for ...

A comparative analysis of CD70-directed CAR-T cells for glioblastoma treatment demonstrates a superior efficacy of the ligand-based construct. Alexandros ...

Unravelling the modified T cell receptor through Gen-Next ...

In this review article, we examine preclinical and clinical outcomes, and limitations as well as present cutting-edge techniques to improve the function of CAR- ...

NCT06946680 | IL-8 Receptor-modified CD70 CAR T Cell ...

CD70 positive (≥5%, 1+) The tumors from the surgical resection or biopsy by immunohistochemistry will be confirmed by a validated assay performed at UF Health ...

CD70, a novel target of CAR T-cell therapy for gliomas - PMC

These data suggest that CD70 is an optimal tumor immunotherapeutic target in glioma and may be employed to improve outcomes in patients with refractory brain ...

CAR-T cell therapy for the treatment of adult high-grade ...

CAR-T cell therapy for brain tumors represents a promising and rapidly growing area of research; however, successful translation remains a ...

IL-8 Receptor Modified Patient-Derived Activated CD70 CAR ...

This is a Phase I Study evaluating the safety and feasibility of IL-8 receptor-modified patient-derived activated CD70 CAR T cells in adult ...