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Title:
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)
Protocol Number:
J17111
Phase:
Phase II
Physician:
Stephanie Gaillard
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
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.
Eligibility:
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.
Treatment:
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.
Population:
Adult
Last Update
12/11/2019 05:03 AM