- Adults with histologically or pathologically confirmed diagnosis of one of the following: (i) Stage III or IV HNSCC not amenable to curative intent treatment; (ii) metastatic Stage IV NSCLC; (iii) unresectable or Stage IV breast cancer; (iv) Stage IV CRC.
- Participant has radiographic disease progression after the most recent line of therapy.
- Participant has received up to 3 prior lines of therapy.
- Participant is assessed as having at least one resectable lesion (or aggregate lesions) with an estimated minimum diameter of 1.5 cm (short axis) for IOV-5001 generation.
Detailed eligibility will be reviewed when participants contact the study team.
This clinical trial is for adults who have an advanced solid tumor that has been treated with approved standard therapy and who have experienced disease progression following this prior treatment. The advanced solid tumor must be either non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), colorectal cancer (CRC), or head and neck squamous cell carcinoma (HNSCC).
The purpose of this study is to find out whether IOV-5001, an investigational study treatment, is safe and effective in treating previously treated advanced solid tumors, including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), colorectal cancer (CRC), or head and neck squamous cell carcinoma (HNSCC). IOV-5001 is “investigational” because it has not been approved by the US Food and Drug Administration (FDA). This is the first time IOV-5001 will be used in humans.
IOV-5001 is a type of immune cell called a tumor-infiltrating lymphocyte (TIL), which are cells produced by the body’s immune system that may recognize and kill cancer (tumor) cells. The IOV-5001 cells are TILs that have been genetically modified with additional molecules that are known to enhance the responses of the TIL.
The IOV-5001 is produced from a participant’s own T cells that are obtained from their tumor. Participant will have surgery to remove some of their tumor(s) in order to collect their T-cells that will be used to make their IOV-5001. It will be approximately 6 weeks after their surgery that participant may start to receive IOV-5001 treatment. IOV-5001 treatment has two parts:
--Before receiving IOV-5001, the participant will receive a preconditioning regimen of chemotherapy medications (cyclophosphamide and fludarabine) as well as mesna, which prevents some of the side effects of cyclophosphamide.
--Then, anywhere from 2 to 3 days later, the participant will be treated with IOV-5001. The participant will have an IV catheter (small tube placed in their vein) for infusion of study treatment.
The length of the study for each participant may be up to 5 years after receiving IOV-5001.