A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic or Persistent Cervical Carcinoma (C-145-04)
Johns Hopkins Kimmel Cancer Center in Baltimore
This research is being done because Iovance Biotherapeutics, Inc. (the Sponsor) is carrying out this study to find out if an investigational product, called LN-145 is safe and beneficial in the treatment of patients with recurrent, metastatic or persistent cervical cancer when previous treatment has not worked.LN-145 is also called “tumor infiltrating lymphocytes” (TIL) and is made up of specialized white blood cells called lymphocytes or “T cells” derived from your tumor. LN-145 is generated by bringing your own tumor into a manufacturing facility to isolate and grow T cells that may attack your tumor whenLN-145 is reinfused back into your body. LN-145 is an autologous cellular therapy, meaning T cells that are derived from your own tumor.The use of “LN-145” in this research study is investigational. The word “investigational” means that “LN-145” is not approved for marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of “LN-145” in this study.
Women over 18 with recurrent, metastatic, or persistent cervical cancer may join. Patients must have received at least 1 prior systemic immunotherapy or chemotherapy treatment for cervical cancer.
The study consists of 3 phases:• Pretreatment Phase (approximately 8 weeks)o Screening Visit (up to 28 days)o Tumor Resection Visit (1 day)o LN-145 Pre-Manufacturing period (approximately3 to 6 weeks)• Treatment Phase (approximately 2 weeks)o NMA lymphodepletion regimen (7 days)o LN-145 Infusion (1 day)o IL-2 Infusion (2 to 4 days)• Follow-up Phase (3 years)o Efficacy follow-up for efficacy evaluations (24 months)o Overall Survival Follow-Up to assess disease status on durable responders and survival until the last subject is followed for 3 years.
08/08/2020 05:02 AM