Cargo Therapeutics Scraps Lead CAR-T Program, Announces Layoffs Following Disappointing Study Results

Cargo Therapeutics, a cell therapy developer, has announced a significant setback in its lead program, resulting in a major restructuring of the company. The decision comes after disappointing Phase 2 study results for firi-cel, their lead CAR-T therapy being tested for large B-cell lymphoma.

Study Results Reveal Safety Concerns and Lack of Durability

The Phase 2 trial of firi-cel, which targeted the CD22 protein in patients who had relapsed after previous CAR-T therapies, showed concerning safety profiles and a lack of durable efficacy. Key findings include:

• 18% of treatment recipients experienced severe or worse immune reactions
• Initial remission rate of 43% dropped to 18% after three months
• Higher-than-expected occurrence and severity of immune-related side effects

Gina Chapman, Cargo's CEO, stated that these results were "unexpected" and fell short of the company's expectations, particularly in terms of the treatment's durability and safety profile.

Company Restructuring and Strategic Shift

In response to these setbacks, Cargo Therapeutics has announced several strategic changes:

1. Discontinuation of the firi-cel program
2. Layoffs affecting 50% of the workforce
3. Shift in focus to other research programs, including CGR-023
4. Evaluation of strategic alternatives, including potential sale or merger

The company's decision to lay off half of its staff is expected to extend its cash runway into mid-2028. As of the end of 2024, Cargo had approximately $368 million in cash reserves.

Looking Ahead: Alternative Programs and Strategic Options

Despite the setback with firi-cel, Cargo Therapeutics is moving forward with other potential therapies:

• CGR-023: A program modifying immune cells to express receptors for three proteins (CD19, CD20, and CD22), which recently received clearance from U.S. regulators to begin human testing
• Preclinical research on cell therapies derived from donor cells rather than individual patients

The company is also exploring strategic options, with some analysts suggesting a reverse merger as a potential path forward given Cargo's substantial cash reserves.

This development marks another in a series of recent setbacks for newly public biotech companies, following disappointing results from Neumora Therapeutics, Alto Neuroscience, and BioAge Labs since October.