Cargo Therapeutics Discontinues Lead CAR-T Program Due to Poor Durability and Safety Concerns

Cargo Therapeutics has discontinued FIRCE-1, a Phase 2 clinical study of firi-cel for patients with large B-cell lymphoma (LBCL)710.

The decision was based on an ad hoc analysis of 51 patients, which revealed an overall response rate of 77% and a complete response rate of 43%710.

Despite initial promising response rates, the durability of complete response at three months was only 18%710.

Safety concerns were a major factor in the decision, with 18% of patients developing severe immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS), including grade 4 and 5 serious adverse events710.

As a result of discontinuing the lead program, Cargo Therapeutics will implement a 50% workforce reduction to extend its cash runway10.

The company will now prioritize the advancement of CRG-023, its tri-specific CAR T therapy, to Phase 1 proof-of-concept data, as well as focus on its novel allogeneic platform710.

Cargo Therapeutics had approximately $368.1 million in preliminary cash as of December 31, 2024, and expects to extend its runway into mid-202810.

The Phase 1 dose escalation study enrollment for CRG-023 is on track to initiate in Q2 202510.

Sources:

7. https://investors.cargo-tx.com/news-releases/news-release-details/cargo-therapeutics-discontinue-firce-1-phase-2-study-firi-cel

10. https://www.stocktitan.net/news/CRGX/cargo-therapeutics-to-discontinue-firce-1-phase-2-study-of-firi-cel-3f1d13ujiwjl.html