ICT Cell Therapy for Ovarian Cancer

Recruiting at 10 trial locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Arsenal Biosciences, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment using modified immune cells (AB-1015) for patients with ovarian cancer that didn't respond to standard treatments. The modified cells are designed to target and kill cancer cells. The goal is to find a safe dose and see if the treatment helps fight the cancer. Modified immune cells, such as those used in AB-1015, have shown good curative effects in treating ovarian cancer.

Research Team

Arsenal Biosciences

Principal Investigator

Arsenal Biosciences

Eligibility Criteria

This trial is for individuals with advanced ovarian, fallopian tube, or primary peritoneal cancer that's resistant to platinum-based treatments. Participants must have high-grade serous histology, at least two prior therapies (including a platinum regimen and possibly a PARP inhibitor if BRCA1/2 mutated), no more than three prior lines of therapy for their resistant disease, and be in good physical condition (ECOG score 0-1). Pregnant women are excluded.

Inclusion Criteria

My cancer is a type of advanced ovarian, fallopian tube, or peritoneal cancer that is resistant to platinum-based chemotherapy.

I've had 2-3 treatments for my cancer, including platinum and PARP inhibitor if BRCA1/2 positive.

I am fully active or can carry out light work.

Exclusion Criteria

I have an autoimmune disease that needs strong medication to control.

I have a serious fluid buildup around my heart.

I have brain metastasis that has not been treated.

Treatment Details

Interventions

• AB-1015 (CAR T-cell Therapy)

Trial Overview AB-1015 cell therapy is being tested in this phase 1 trial to find the safest dose for future studies. The study will enroll subjects who've had recurrent cancer despite treatment and will use an escalating dose approach followed by additional enrollment into 'backfill cohorts' once safe levels are identified.

Participant Groups

Group I: AB-1015 Experimental Treatment 1 Intervention

Patients receive fludarabine and cyclophosphamide intravenously on days -5 to -3. Patients receive a single dose of AB-1015 intravenously on day 0.

Who Is Running the Clinical Trial?

Arsenal Biosciences, Inc.

Lead Sponsor

Trials

2

Recruited

150+