Oncternal Therapeutics (NASDAQ:ONCT) traded lower on Tuesday after announcing initial results from its Phase 1/2 study for autologous CAR T cell therapy, ONCT-808-101, in patients with B-cell lymphoma, a cancer affecting the immune system.
Citing data from three patients who received initial dosing, San Diego, California-based Oncternal (ONCT) said that two achieved a complete metabolic response, while the third achieved a partial response.
The dose escalation/dose expansion trial was designed to evaluate ONCT-808-101 in patients with relapsed or refractory aggressive B-cell lymphoma who have failed in prior CD19-targeted CAR T therapy.
However, the readout indicated a Grade 5 (fatal) serious adverse event in a patient who received the second dose level of 3×106 CAR T cells per kg. The 80-year-old subject had received four previous lines of therapy.
Oncternal (ONCT) also said that the FDA has greenlighted several changes to the trial, including modifications to eligibility criteria and a plan to test lower doses for future patients.
“With this clear path forward, we plan to implement the protocol amendment as rapidly as possible,” Chief Medical Officer Salim Yazji noted.