Fate Therapeutics wins $15 million grant for lupus-nephritis trial

Fate Therapeutics ($FATE) received a $15 million grant from the California Institute for Regenerative Medicine to support RECLAIM-LN, a Phase 2 study of FT819. The experimental off-the-shelf CAR-T treatment will be evaluated in approximately 53 patients with moderate-to-severe lupus nephritis who have not responded adequately to at least two prior immunosuppressive therapies.

The open-label, single-arm trial’s primary assessment is renal response at 26 weeks. Fate describes the study as potentially registrational, linking the funding to a possible future approval pathway rather than routine exploratory work alone. However, the grant is a financing milestone, not new evidence that FT819 is effective. Trial execution, patient outcomes and regulatory discussions will determine whether the program can support an eventual application.

Sources:

• Fate Therapeutics — CIRM grant and RECLAIM-LN program, GlobeNewswire release