Study Details

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Phase I Study of Autologous CAR T-Cells Targeting the B7-H3 Antigen in Recurrent Epithelial Ovarian

To find the safest and most tolerable dose of CAR.B7-H3 T cells to administer in patients with relapsed/refractory platinum-resistant epithelial ovarian cancer.

Age & Gender

18 years ~ 99 years
Female

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

United States (Nationwide)

What will be asked of you

After a consultation with the study team your blood will be collected so the manufacturing process to make 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 you are eligible, you will complete three to four 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 clinic for follow-up assessments 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:
Variable - based on disease and side effects

Phone or online visits:
Variable - based on worsened disease

Total length of participation:
Total participation of 5 years - This includes study treatment, short-term follow up, and long-term follow up.

Looking for Specific Volunteers

Able to participate:

Confirmed diagnosis (confirmed by pathology review of tissue or blood collection) of epithelial ovarian, peritoneal, or fallopian tube cancer; diagnosis must be considered "high-grade serous"
Relapsed or refractory (unresponsive) disease after 2 or more types of treatment
Disease that is able to have response to treatment evaluated, defined as a site of disease >1 cm (if outside of the lymph nodes)
Willingness to comply with study requirements (stay close to UNC first 2 weeks, port placement, biopsy etc.)
Adequate performance status (ability to perform daily tasks) and organ function, based on specified laboratory results/parameters and required echocardiogram prior to cell collection

Not eligible if:

Use of corticosteroids at doses of 10 mg or more of prednisone (or its equivalent)
Presence of metastases to lung or brain
Signs or symptoms of bowel obstruction or abscess in abdomen within 3 months of starting treatment; history or bowl perforation or diverticulitis
Active infection with HIV, HTLV, Hepatitis B or Hepatitis C
Washout exclusions related to surgery and treatments.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Immunotherapy Team
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 (Phase 1 Trials (all cancers), Ovarian)

IRB Number

20-1673

ClinicalTrials.gov

NCT04670068