NEW YORK – Cargo Therapeutics on Wednesday said it will stop a Phase II trial for an investigational autologous CAR T-cell therapy due to lackluster activity and focus on advancing a tri-specific CAR T-cell therapy candidate and its allogeneic cell therapy platform.
In line with this decision, the company said it will reduce its workforce by 50 percent.
In the discontinued Phase II study, FIRCE-1, San Carlos, California-based Cargo was testing firicabtagene autoleucel, or firi-cel, in patients with large B-cell lymphoma (LBCL) who had relapsed or become refractory to a CD19 CAR T-cell therapy. Safety events in that trial prompted an ad hoc analysis, which showed a 77 percent overall response rate and a 43 percent complete response rate, 18 percent of whom maintained their complete responses for three months. Additionally, 18 percent of patients had a grade 3 or higher immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS).
Based on this data, the firm decided that firi-cel didn't have a "competitive benefit-risk profile" and decided to discontinue FIRCE-1. "We are disappointed with these unexpected results from our Phase II study. Durability of complete response is an important clinical goal for LBCL patients who are [relapsed or refractory] to CD19 CAR T-cell therapy," Cargo President and CEO Gina Chapman said in a statement. "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. Therefore, we believe it is in the best interest of both patients and shareholders to discontinue the study."
Cargo will present detailed analysis of the FIRCE-1 study at a medical conference.
The discontinuation of the trial will lead to layoffs, and the company will incur related expenses in the range of $31 million and $37 million, which will largely be recognized in the first quarter of 2025, the firm said in a filing with the US Securities and Exchange Commission.
Cargo expects the strategic changes will extend its cash runway into mid-2028, allowing it to advance CRG-023, a CAR T-cell therapy designed to target CD19, CD20, and CD22 and overcome relapse, into a Phase I dose-escalation study in the second quarter of 2025; use its allogeneic platform to select a lead vector candidate; and evaluate its strategic options. As of Dec. 31, the company had preliminary cash, cash equivalents, and marketable securities of $368.1 million.