Date: 2017-09-13
Type of
information: Clinical trial authorisation
phase: 2
Announcement: clinical trial authorization
Company: Iovance Biotherapeutics (USA - CA)
Product: LN-145
Action
mechanism:
- immunotherapy product/cell therapy. LN-145 is an adoptive cell transfer (ACT) therapy that utilizes an autologous TIL manufacturing process.
Disease: recurrent, metastatic or persistent cervical carcinoma
Therapeutic
area: Cancer - Oncology
Country: France, The Netherlands, Spain, Switzerland, UK, USA
Trial
details:
- C-145-04 is a Phase 2, multicenter, single-arm, open-label interventional study that will enroll up to 47 patients and will assess the safety and efficacy of LN-145 for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma. The cell transfer therapy used in this study involves patients receiving a non-myeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL and the administration of a regimen of up to six doses of IL-2. (NCT03108495)
Latest
news:
- • On September 13, 2017, Iovance Biotherapeutics announced the approval of the Clinical Trial Application (CTA), by the competent authority (CA) in the Netherlands, for a Phase 2 trial of LN-145 for the treatment of patients with recurrent, metastatic or persistent cervical carcinoma. Iovance initiated the submission of CTAs in multiple countries in Europe starting in August 2017 in support of clinical trials in cervical carcinoma and metastatic melanoma.
Is
general: Yes
