Study Details

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Study of CAR-T cells in patients with recurrent epithelial ovarian, peritoneal, or fallopian tube cancer

The purpose of this study is to test the safety and tolerability of using a new treatment called iC9-CAR.B7-H3 T cells in patients with ovarian, peritoneal or fallopian tube cancer.

Age & Gender

18 years ~ 99 years
Female

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

Your blood will be collected so the process of making the modified study treatment cells can begin. The modified study cells will hopefully be more effective at killing your cancer cells than your body's normal cells. The study team will do blood tests and other procedures to confirm it is safe for you to get the modified study cells. If it is safe, you will complete three days of pre-treatment that will prepare your body to accept the study cells better. You will then receive the study cell infusion. You will have to stay near the hospital after infusion and will be seen frequently in the clinic for follow-up visits that may include lab tests, imaging, or biopsies of your tumor. You will continue follow-up visits based on how well you have responded to the study treatment.

In-person visits:
Minimum of 14 clinic visits for the first year, possibly more depending on side effects of treatment

Total length of participation:
1 year for treatment and initial follow up visits. Up to 15 years for long-term follow up.

Looking for Specific Volunteers

Able to participate:

You have epithelial ovarian, peritoneal, or fallopian tube cancer
Your cancer is recurrent and platinum-resistant or platinum-refractory
You must be able to have intraperitoneal port placed for treatment
You must be willing to undergo tumor biopsies prior to treatment, after infusion, and if your disease gets works, as long as it is safe

Not eligible if:

You have active infection with HIV, HBC, or HCV
You have known brain, lung, or bone metastases (some exceptions for pleural effusions and prior brain metastases that have been treated and not causing symptoms)
You are using daily systemic corticosteroids at doses greater than 10mg
You have had a bowel obstruction or intra-abdominal abscess recently, or a history of perforation of your gastrointestinal tract
You require frequent IV hydration or you are not able to obtain nutrition orally

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

UNC Immunotherapy
UNCImmunotherapy@med.unc.edu

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Linda Van Le
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Ovarian)

IRB Number

23-3044