An off-the-shelf CAR T therapy is dosed as a same-day outpatient treatment

Fate Therapeutics said on 14 August 2026 that it has dosed the first patient in RECLAIM-LN (NCT07570862), a Phase 2 trial of FT819 in refractory lupus nephritis. The patient was treated in an outpatient setting and discharged the same day.

FT819 is a CD19-targeting CAR T cell manufactured from a clonal master bank of induced pluripotent stem cells rather than from the patient’s own blood. That is the difference the trial is testing in practice: conventional CAR T therapy requires collecting a patient’s T cells, engineering them, and admitting the patient for intensive lymphodepleting chemotherapy. Here the cells come off a shelf, the conditioning is a single less-intensive course of bendamustine, and the visit ended the day it began.

The trial expects to enrol about 53 patients with Class III or IV lupus nephritis who have failed at least two prior systemic immunosuppressive therapies. Each receives one dose of 900 million cells. The primary endpoint is complete renal response at week 26, with enrolment expected to finish in the first half of 2028.

FT819 carries the FDA’s Regenerative Medicine Advanced Therapy designation and was selected for the agency’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot. One patient has been dosed; no efficacy data from this trial exist yet.