Fate Therapeutics’ FT836 CAR T Therapy Cuts Colorectal Cancer Lesions by Up to 52% Without Chemotherapy
FATE•Fate Therapeutics reported Phase 1 results showing FT836 off-the-shelf CAR T cell therapy achieved tumor reduction up to 52% in KRAS wild-type metastatic colorectal cancer patients without lymphodepleting conditioning chemotherapy. The treatment demonstrated no dose-limiting toxicities, cytokine release syndrome, neurotoxicity or graft-versus-host disease across nine enrolled patients.
1. Phase 1 Study Design
Nine metastatic colorectal cancer patients were enrolled in a Phase 1 trial evaluating FT836 off-the-shelf CAR T cells combined with cetuximab or trastuzumab. As of the April 20 data cutoff, six patients received FT836 plus cetuximab (Regimen C) and three received FT836 plus trastuzumab (Regimen E), all administered without lymphodepleting conditioning chemotherapy.
2. Preliminary Efficacy Results
Among five efficacy-evaluable patients, two heavily pretreated KRAS wild-type mCRC cases showed meaningful anti-tumor activity: one patient experienced a 19% decrease in target lesion sum and a 62% drop in CEA biomarker levels, while another achieved a 52% reduction in a liver lesion with overall stable disease.
3. Favorable Safety Profile
FT836 demonstrated no dose-limiting toxicities, cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome or graft-versus-host disease across all nine patients, highlighting a clean tolerability profile even without conditioning chemotherapy.
4. Sword and Shield™ Technology
FT836 incorporates dual-engineering Sword and Shield™ features: an alloimmune-defense receptor eliminates host immune cells that would reject the product, while CD58 deletion confers resistance to immune surveillance, enabling FT836 to traffic to and persist in peripheral blood and tumor tissue without lymphodepletion.
