Study Details

Open

Study of CD30 CAR-T cells for Non-seminomatous Germ Cell Tumors (NSGCT)

The purpose of this study is to use the body's own immune cells, modify them, and give them back to you as a treatment for your NSGCT.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

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

Your blood will be collected so the 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 it is safe, 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 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 13 clinic visits for the first year, possibly more depending on side effects of treatment

Phone or online visits:
All visits will be done in person unless your disease has gotten worse, then you may be contacted by phone for follow-ups

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 a diagnosis of Nonseminomatous Germ Cell Tumors (NSGCT) of any primary site with documented CD30 expression
You have received at least one prior treatment for your cancer, and it has progressed or not responded to treatment
Your disease is able to be evaluated with imaging or tumor serum markers
You either have tumor tissue from a previous procedure available for testing, or will be willing to have a biopsy to get new tumor tissue
Willing to stay close to UNC and complete all follow ups with clinical staff

Not eligible if:

You are currently using general corticosteroids at doses of greater than or equal to 10 mg of prednisone (or equivalent) per day
You have active Human Immunodeficiency Virus (HIV), Human T-Cell Lymphotropic Virus (HTLV), Hepatitis B (HBV), or Hepatitis C (HCV) infection.
You have an abnormal electrocardiogram (ECG) per the study team
You are pregnant, planning to become pregnant, or breastfeeding
You are unwilling to undergo tumor biopsy procedures

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

UNC Immunotherapy
UNCImmunotherapy@med.unc.edu

Visit Study Website

Primary Visit Location

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

Additional Study Information

Principal Investigator

Matthew Milowsky
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Other Cancers)

IRB Number

22-0121

ClinicalTrials.gov

NCT05634785