Cargo halts lead CAR-T study, cuts workforce in half

Cargo Therapeutics will discontinue a phase 2 trial of its lead autologous CD22 CAR-T cell product candidate, firi-cel, for patients with large B-cell lymphoma whose disease relapsed or didn’t respond to CD19 CAR T-cell therapy.

In line with this decision, Cargo will reduce its workforce by approximately 50% to extend cash runway and prioritize the advancement of CRG-023, its tri-specific CAR-T, into a phase 1 dose escalation study.

Based on an ad hoc analysis of the FIRCE-1 study prompted by recent safety events, the company believes the results do not support a competitive benefit-risk profile of firi-cel for the intended patient population. According to Cargo, while data from 51 patients with at least one post baseline scan demonstrated an overall response rate of 77% and complete response rate (CR) of 43%, the durability of CR at three months was 18%.

In addition, safety data indicated 18% of patients developed immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) — a toxicity associated with CAR-T cell therapy — that were grade 3 or higher, including grade 4 and grade 5 serious adverse events.

“We are disappointed with these unexpected results from our phase 2 study. Durability of complete response is an important clinical goal for LBCL patients who are R/R to CD19 CAR-T cell therapy. Combined with a higher-than-expected occurrence and severity of IEC-HS, the data generated so far does not meet our expectations of a competitive benefit-risk profile for patients in the context of available treatment options,” said Gina Chapman, Cargo’s president and CEO. “While we continue to advance CRG-023 into the clinic this year and progress our novel allogeneic platform, we will also evaluate our strategic options.”