Study Details

Open

GD2-CAR-T cell therapy for small cell and non-small cell lung cancers

The purpose of this study is to test the safety of using a new treatment called GD2-CAR-T cell therapy (iC9-GD2.CAR.IL-15 T cells) in patients with small cell lung cancer or non-small cell lung cancer. This treatment is experimental and has not been approved by the Food and drug administration. The study team wants to know how much (dose) of the iC9-GD2.CAR.IL-15 T cells is safe to use in patients without causing too many side effects and if they are, what is the maximum dose that could be tolerated.

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

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 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 iC9-GD2.CAR.IL-15 T cells 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:
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 a diagnosis of extensive stage small cell lung cancer or Stage IV non-small cell lung carcinoma
Your cancer has not responded to FDA approved agents for your type of cancer. Specific criteria applies to type of disease.

Not eligible if:

You have brain metastases OR, if brain metastases are present, they must be determined by your doctor to be stable enough to participate.
You are using systemic corticosteroids at doses of 10 mg or more of daily prednisone
You have an active infection, including HIV, HTLV, Hep B or Hep C, or other uncontrolled and active bacterial, viral, or fungal infection

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

Jared Weiss
Lineberger Comprehensive Cancer Center

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Lung, Phase 1 Trials (all cancers))

IRB Number

22-2289

ClinicalTrials.gov

NCT05620342