Study Details

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Phase I Study of CAR-T Cells Targeting the B7-H3 Antigen in Patients with Refractory Pancreatic Ductal Adenocarcinoma (PDAC)

This is a research study for patients with pancreatic ductal adenocarcinoma that came back after receiving standard therapy. In this study, we want to test the safety and tolerability of a new investigational treatment. This treatment is called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9.CAR.B7-H3 T cells).

Age & Gender

18 years ~ 99 years
Male, 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, we will collect your blood 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 able to take part, 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 iC9.CAR.B7-H3 T cells. 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:
Up to 15 years - this includes treatment, short-term follow up, and long-term follow up.

Looking for Specific Volunteers

Able to participate:

You have confirmed pancreatic ductal adenocarcinoma.
You are willing and able to comply with study procedures and requirements
You are willing to undergo a biopsy at various timepoints throughout the study

Not eligible if:

You have active infection with HIV, HBV, or HCV
You have not received at least one prior line of chemotherapy for metastatic pancreatic cancer
Your organ function is inadequate per study guidelines

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

Ashwin Somasundaram
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Pancreatic)

IRB Number

23-2499

ClinicalTrials.gov

NCT06158139