Clinical Trial TitleA Phase 2, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes (TILs) in Subjects with Advanced Melanoma (DELTA-1)
National Clinical Trial Number:NCT05050006
Clinical Trial Protocol Description:
The purpose of this study is to test the safety and effectiveness of an investigational product called ITIL-168, a personalized cell therapy made from collecting T cells residing within your own tumor and intended to enhance your immune system’s response against melanoma (skin cancer). “Investigational” means that the product is not approved by the U.S. Food and Drug Administration (FDA) and it must be tested to see if it is a safe and effective treatment for the disease or condition being studied.
The study will determine if ITIL-168 is safe and effective in treating advanced melanoma. The investigational product to be tested, ITIL-168, is made from Tumor Infiltrating Lymphocytes, also referred to as “TILs”. TILs are white blood cells that are found within the tumor tissue. TILs are located in tumors because they are one of your body’s natural defenses against cancer cells. Though TILs are trying to kill cancer cells, in many cases there are not enough TILs to treat the cancer.
Participants will be assigned to 1 of 3 groups depending on how they responded to prior treatment:
- Group 1: did not respond to treatment or responded to treatment but soon worsened
- Group 2: did not tolerate prior treatment
- Group 3: did not progress or improve on prior treatment, having instead stable disease
Participants who have tumor removal surgery to make ITIL-168 will be enrolled in the study.
If you agree to participate in this study, your participation may last approximately 5 years. The first visits for checking your disease response are at weeks 6 and month 3 after your ITIL-168 administration Afterwards, depending on your disease response status, you will either continue to return to the clinic every 3 to 6 months to monitor your response to the investigational product or the research staff may contact you by telephone for up to 5 years to monitor the status of your disease.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have histologically confirmed advanced (unresectable or metastatic) cutaneous melanoma. Medically suitable for surgical resection of tumor tissue
- Cohort 1: Disease that is relapsed after or refractory to at least 1 prior line of systemic therapy that must include a PD-1 inhibitor and, if positive for proto-oncogene BRAF V600 activating mutation, targeted therapy.
- Cohort 2: Disease that is persistent after discontinuing PD-1 due to toxicity. Patients with a proto-oncogene BRAF V600 activating mutation must have progressed after targeted therapy.
- Cohort 3: Disease that is stable (SD) after at least 4 doses of a PD-1 inhibitor. Patients with a proto-oncogene BRAF V600 activating mutation must have progressed after targeted therapy.
You will be excluded from the study if any of the following criteria apply to you:
- Have had another primary malignancy within the previous 3 years.
- Have melanoma of uveal, acral, or mucosal origin.
- Have previously received an allogeneic stem cell transplant or organ allograft.
- Have previously received TIL or engineered cell therapy ( eg, CAR T-cell).
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.