CAR T Cell Therapy for Brain Tumors

(IMPACT MET Trial)

Overseen By Taryn King, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Florida

Must not be taking: Chemotherapy, Immunotherapy, Immunosuppressants, others

Disqualifiers: HIV, Heart failure, Autoimmune, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

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 patients with brain metastases from primary cancer, with either newly diagnosed lesions or recurrent or progressive disease after prior therapy.

Who Is on the Research Team?

Maryam Rahman, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

Inclusion Criteria

KPS ≥ 70

Histological confirmation of primary cancers

Histologic confirmation of CD70 on primary tumor, lymph node, or BM biopsy

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.

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

How Is the Trial Designed?

Group I: IL-8 receptor-modified patient-derived activated CD70 CAR T cells Experimental Treatment 1 Intervention

Two dose levels Cohort 1 will receive 1 x 10\^7 cells/kg; Cohort 2 will receive 1 x 10\^8 cells/kg

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+