Modified CAR T Cells for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Precigen, Inc

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a Phase I/Ib dose escalation, dose expansion, study to evaluate the safety and identify the recommended dose of modified immune cells PRGN-3005 (autologous chimeric antigen receptor (CAR) T cells developed by Precigen, Inc.) in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body, that has come back and is resistant to platinum chemotherapy. Autologous CAR T cells are modified immune cells that have been engineered in the laboratory to specifically target a protein found on tumor cells and kill them.

Eligibility Criteria

This trial is for women with advanced, recurrent ovarian, fallopian tube, or primary peritoneal cancer that's resistant to platinum chemotherapy. Participants must have measurable disease and be in good health otherwise. They should not be pregnant and agree to use two contraception methods during the study.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

I can understand and sign a consent form.

My ovarian, fallopian tube, or peritoneal cancer is resistant to standard treatments.

My cancer worsened within 6 months after platinum-based treatment.

Exclusion Criteria

I have or have had treatment for brain metastases.

I have lung issues like high blood pressure in lungs, scarring, or difficulty breathing and my oxygen levels or lung tests are very low.

I am not pregnant or breastfeeding.

I do not have serious heart conditions like unstable angina, severe heart failure, or significant hypotension.

I have an autoimmune disease that is not controlled even with treatment.

I need regular treatments for severe fluid buildup in my abdomen.

I have a history of HIV, West Nile, Zika, or active hepatitis B or C.

I have an active seizure disorder.

I am a woman under 60 and cannot become pregnant due to menopause or sterilization.

Participant Groups

The trial tests PRGN-3005 UltraCAR-T cells, which are modified immune cells designed to target and kill tumor cells in patients with certain types of cancer that have spread or returned after treatment.

2Treatment groups

Experimental Treatment

Group I: Treatment (PRGN-3005 UltraCAR-T cells) IV AdministrationExperimental Treatment1 Intervention

Patients receive autologous PRGN-3005 UltraCAR-T cells via IV administration with or without lymphodepleting chemotherapy.

Group II: Treatment (PRGN-3005 UltraCAR-T cells) IP AdministrationExperimental Treatment1 Intervention

Patients receive autologous PRGN-3005 UltraCAR-T cells via IP administration with or without lymphodepleting chemotherapy.