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Clinical Trials

Date: 2017-08-16

Type of information: Treatment of the first patient

phase: 2

Announcement: treatment of the first patient

Company: Lion Biotechnologies (USA - CA), now Iovance Biotherapeutics (USA - CA)

Product: LN-145

Action mechanism:

  • cell therapy/immunotherapy product. LN-145 is an adoptive cell transfer (ACT) therapy that utilizes an autologous TIL (Tumour Infiltrating Lymphocyte)  manufacturing process as originally developed by the NCI.

Disease: cervical cancer

Therapeutic area: Cancer - Oncology

Country: 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 August 16, 2017, Iovance Biotherapeutics announced that the first patient was dosed in its C-145-04 Phase 2 trial of LN-145 for the treatment of patients with recurrent, metastatic or persistent cervical carcinoma. “This marks an important milestone for Iovance, as patient dosing is now ongoing in all three of our internal Phase 2 trials. We initiated this study based on encouraging data generated by the National Cancer Institute (NCI) showing responses in three of the nine cervical cancer patients treated with TIL therapy. This patient population had received standard of care treatment including prior chemotherapy or chemoradiotherapy. Two patients from this study continued to have a complete response at 46 months and 54 months of follow up. The C-145-04 trial will investigate the effect of Iovance’s TIL therapy in cervical cancer patients. We look forward to progressing the study with the intent to report some initial data in 2018,” said Dr. Maria Fardis, PhD, MBA, Chief Executive Officer of Iovance Biotherapeutics.
  • • On February 1, 2016, Lion Biotechnologies announced that the FDA has allowed its investigational new drug (IND) application to conduct clinical trials of LN-145 in the treatment of cervical cancer, and head and neck squamous cell carcinoma (HNSCC). Each of the single-arm studies will be conducted at up to six sites in a total of 10 patients with either recurrent or metastatic HNSCC, or recurrent or metastatic cervical carcinoma. The objectives of the studies are to assess safety, tolerability and various indicators of efficacy.

Is general: Yes