FDA lifts partial clinical hold on Adaptimmune’s study of T-cell therapy in MRCLS

The partial hold was placed on the study in August of this year, requesting chemistry, manufacturing, and controls data and clarifications to several trial design questions.

Now that the partial hold has been lifted, Adaptimmune is all set to start the study in up to 15 MRCLS patients.

Patient screening is anticipated to start in the fourth quarter of this year. Results from the trial will inform a potential future registration study.

Adaptimmune, which was founded in 2008, develops novel cancer immunotherapy products based on its SPEAR T-cell platform.

The company intends to use the body’s own machinery, the T-cell, to target and destroy cancer cells by leveraging engineered, increased affinity TCRs as a means of strengthening natural patient T-cell responses.

Its SPEAR T-cell therapy lead program targets the NY-ESO cancer antigen.

The NY-ESO SPEAR T-cell therapy showed indications of efficacy and tolerability in phase 1/2 trials in solid tumors and in hematologic cancer types, such as synovial sarcoma and multiple myeloma.

Adaptimmune said the initial data also suggests a promising risk/benefit profile.

The company said it continues to expand its clinical trials in the US. It has also submitted applications to the UK’s Medicines and Healthcare Products Regulatory Agency and to Health Canada.

Adaptimmune is developing NY-ESO TCR therapeutic candidate in partnership with GlaxoSmithKline.