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

Protocol No
IOVANCE-C-145-04-CERVICAL
Principal Investigator
Janet Rader
Phase
II
Summary
Iovance Biotherapeutics, Inc. (Sponsor) is carrying out this study to find out if an Investigational Medicinal Product (IMP), called LN-145 (referred to as “investigational product”) 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” grown from your tumor. LN-145 is generated by sending a piece of your own tumor to a central manufacturing facility (or lab) to isolate and grow your body’s own T cells in order to give them back to you to help fight your tumor. LN-145 is an investigational product. “Investigational” means that is has not been approved by the Food and Drug Administration (FDA), or any other health authority. LN-145 is an autologous cellular therapy, meaning T cells that are derived from your own tumor. About 47 female patients aged over 18 with recurrent, metastatic, or persistent cervical cancer will participate and complete treatment on this study. Completing treatment means the participant has been successfully completed the pre-conditioning chemotherapy, then infused with LN-145. The treatment is followed by Interleukin-2 (IL-2), a protein which helps white blood cells regulate their immune response.
Description
Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic, or Persistent Cervical Carcinoma
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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