Clinical Trials

Date: 2017-08-17

Type of information: Publication of results in a medical journal

phase: 1

Announcement: publication of results in the Journal of Clinical Oncology (JCO)

Company: Kite Pharma (USA - CA)

Product: KITE-718 (MAGE A3/A6 -Autologous genetically modified MAGE-A3/A6 TCR transduced T cells)

Action mechanism:

cell therapy/gene therapy/immunotherapy product. KITE-718 is a T cell therapy engineered to express T cell receptors (TCRs) that target MAGE A3 and MAGE A6. MAGE A3/A6 are frequently found in common tumors including bladder, esophageal, head and neck, lung and ovarian cancers. KITE-718 recognizes the MAGE A3 and MAGE A6 fragments bound to a Class II HLA (DPB1*04:01) and therefore has the potential to kill tumor cells both directly and indirectly through activation of the immune system given it incorporates a class II TCR. Class II HLA (DPB1*04:01) is found in 50 percent to 70 percent of Caucasians.
KITE-718 is built on the proof of concept data established by the National Cancer Institute's (NCI) MAGE A3/A6 TCR program (NCT02111850). No off-target toxicity was observed in the NCI study, and evidence of tumor regression was seen in patients with multiple types of solid tumors. KITE-718 has been optimized from the foundational work at the NCI by streamlining the manufacturing process through advanced technologies and next-generation cell manufacturing conditions.

Disease: solid tumors

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

KITE-718 is a single-arm, dose escalation study evaluating the safety and efficacy of T cells engineered with the same TCR used in the NCI study in patients with advanced cancers.
The research, led by Steven A. Rosenberg , M.D., Ph.D., Chief of the Surgery Branch at NCI's Center for Cancer Research , was performed, in part, pursuant to a Cooperative Research and Development Agreement (CRADA) between NCI and Kite. (NCT03139370).

Latest news:

• On August 17, 2017, Kite Pharma highlighted the publication of results in the Journal of Clinical Oncology from a National Cancer Institute (NCI) study evaluating the safety and efficacy of a MAGE A3 T cell receptor (TCR) engineered T-cell therapy.
In this dose-escalation study, 17 patients with a variety of metastatic solid tumors were treated with a single dose of a MHC class II (HLA-DPB*0401)-restricted MAGE A3 TCR engineered T-cell therapy after a chemotherapy conditioning regimen. Responses were observed in 4 patients, including a complete remission in a patient with metastatic cervical cancer that is ongoing at 29 months. Among the 9 patients treated at the target dose level, evidence of tumor regression was seen in 3 patients with esophageal cancer, urothelial cancer, and osteosarcoma. All three responders had significant levels of the TCR engineered T cells in blood, at 1 month post-treatment. The patient with urothelial cancer remains in partial remission at 19 months. No unexpected off-target toxicity was seen, and there were no treatment-related deaths.
• On January 3, 2017, Kite Pharma announced that it has submitted an Investigational New Drug (IND) application with the FDA to initiate a Phase 1 trial of KITE-718, a T cell therapy engineered to express T cell receptors (TCRs) that target MAGE A3 and MAGE A6. The trial is designed to assess the safety and anti-tumor effect of KITE-718 on these solid tumors.