Clinical Trials

Date: 2017-05-10

Type of information: Initiation of patient enrollment

phase: 1

Announcement: initiation of patient enrollment

Company: Adaptimmune Therapeutics (UK)

Product: autologous genetically modified T-cells expressing affinity enhanced T-cell receptors (TCRs) specific for alpha fetoprotein (AFP)

Action mechanism: cell therapy/gene therapy/immunotherapy product.

Disease: locally advanced or metastatic hepatocellular carcinoma

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

This Phase I, open label, dose escalation study is designed to evaluate the safety and anti-tumor activity of Adaptimmune’s alpha fetoprotein (AFP) therapeutic candidate in hepatocellular carcinoma. The primary objective of the study is to evaluate the safety and tolerability of this second-line therapy (post-sorafenib) in patients with AFP-positive hepatocellular carcinoma. Additional objectives include anti-tumor activity, persistence of genetically modified cells in the body, and evaluation of the phenotype and functionality of genetically modified cells isolated from peripheral blood or tumor post infusion. (NCT03132792)

Latest news:

• On May 10, 2017, Adaptimmune Therapeutics announced that it has initiated the first site for its AFP SPEAR T-cell study in patients with locally advanced or metastatic hepatocellular carcinoma. This study is now open for enrollment. The study will enroll up to 30 patients with measurable, histologically confirmed hepatocellular carcinoma, not amenable to resection or loco-regional therapy, and with progressive disease. • On April 7, 2016, Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in the use of TCR engineered T-cell therapy to treat cancer, announced that the FDA has accepted the company’s investigational new drug (IND) application for autologous genetically modified T-cells expressing affinity enhanced T-cell receptors (TCRs) specific for alpha fetoprotein (AFP) in patients with locally advanced or metastatic hepatocellular carcinoma. The IND is now active. The acceptance of this IND allows Adaptimmune to initiate an open label Phase I study designed to evaluate the safety and anti-tumor activity of its AFP therapeutic candidate in hepatocellular carcinoma. Site selection activities are under way, and the company anticipates that enrollment will commence in the second half of 2016.
This will be Adaptimmune’s second wholly-owned therapeutic candidate to enter clinical trials. The company initiated a study in December 2015 to evaluate its unpartnered T-cell therapy targeting the MAGE-A10 cancer antigen in patients with non-small cell lung cancer.