| HRA004715
(Controlled Access)
|
We report a phase 1 study (NCT02959905) of Neo-T therapy with lymphodepletion at various dose intensity in patients with locally advanced or metastatic melanoma and colon cancers that are refractory to standard therapies. The primary end point is safety and the secondary end point is objective response rate (ORR). Results show that the treatment is well tolerated with lymphopenia being the most common adverse event in the highest-intensity lymphodepletion groups. Neo-T infusion-related adverse events are only grade 1-2 in the no lymphodepletion group. The median progression-free survival is 7.1 months (95% CI:3.7-9.8), the median overall survival is 16.8 months (95% CI: 11.9-31.7), and the ORR is 33.3% (3/9) among all groups. |
