About the IOV-GE1-201 trial
IOV-GE1-201 is a multicenter, open-label study evaluating whether IOV-5001, an investigational IL 12–tethered tumor infiltrating lymphocyte (TIL) cell therapy made from a patient’s own immune cells, may help the body fight advanced solid tumors that have progressed following prior treatment.
The trial is enrolling adults across several tumor types to learn whether IOV-5001 is safe and can:
- Reduce tumor size
- Slow tumor growth
- Shrink or clear tumors seen on scans
- Help keep the cancer from getting worse
Patients may be eligible to participate in this trial if:
The study includes separate groups (cohorts) for different cancers. In general, patients may be eligible if they are 18 years of age or older, have an advanced or metastatic solid tumor that has progressed after their most recent treatment, and have received up to three prior lines of therapy. Select a cancer type below for its specific criteria.
Cohort 1: Non-small cell lung cancer (NSCLC)
- Stage IV NSCLC without EGFR, ALK, or ROS1 genomic alterations
- Cancer has progressed after platinum-based chemotherapy and an immunotherapy (immune checkpoint inhibitor)
- Patient received an approved targeted therapy first if another actionable mutation is present and treatment is available
- Adequate lung function confirmed by a walking test and, when needed, spirometry (breathing) tests
Cohort 2: Triple-negative breast cancer (TNBC)
- Unresectable or stage IV breast cancer that is triple negative (TNBC) or ER low (estrogen receptor in 1% to 10% of tumor cells); HER2-low and HER2-ultralow tumors are allowed
- Cancer has progressed after the most recent line of therapy
- Patient received at least one prior line of chemotherapy for unresectable or stage IV breast cancer
- Patient has progressed on, or is not a candidate for, other standard treatments—such as sacituzumab govitecan, a PARP inhibitor (if BRCA1/BRCA2 mutated), trastuzumab deruxtecan (if HER2 low), or pembrolizumab (if PD-L1 CPS ≥10)
Cohort 3: Colorectal cancer (CRC)
- Stage IV colorectal cancer
- Cancer has progressed after standard treatments, which may include a fluoropyrimidine, oxaliplatin, and irinotecan plus anti-VEGF. For certain tumors, it may include anti-EGFR therapy
- Patient received an immunotherapy (immune checkpoint inhibitor) if the tumor is microsatellite instability (MSI-H) and/or deficient mismatch repair (dMMR)
- MSI-H or dMMR status already known from prior testing
Cohort 4: Head and neck squamous cell carcinoma (HNSCC)
- Stage III or IV HNSCC that cannot be cured with standard treatment
- Cancer has progressed after an immunotherapy (immune checkpoint inhibitor) and platinum-based chemotherapy (unless platinum was not an option)
- PD-L1 status has been documented
- Adequate lung function, confirmed by breathing tests or a walking test
CPS, combined positive score; EGFR, epidermal growth factor receptor; PARP, poly (ADP-ribose) polymerase inhibitor; VEGF, vascular endothelial growth factor.
Get started
To learn more about IOV-GE1-201 and whether it may be an option for a patient, contact the study team.
This website is intended for a U.S. audience. TIL cell therapy is not yet approved by any regulatory or health agency for the investigational uses described on this website. This website is for educational purposes only and is not intended to replace discussions with a healthcare professional.
