Fate Therapeutics doses first lupus nephritis patient in Phase 2 FT819 trial, clears FT839 IND

Fate Therapeutics reported on August 13, 2026 that the first patient has been dosed in RECLAIM-LN, which to the company's knowledge represents the first patient treated with an iPSC-derived off-the-shelf CAR T-cell therapy in a potentially registrational clinical trial in an autoimmune disease.¹ The patient was treated in an outpatient setting with same-day discharge and with a drug product that was available on-demand.¹

The trial is expected to enroll approximately 53 patients and evaluate a single dose of FT819 administered at 900 million cells following bendamustine conditioning, with complete renal response at Week 26 as the primary endpoint.¹ The company aims to complete enrollment of RECLAIM-LN in the first half of 2028.¹ It also received UK MHRA authorization to conduct RECLAIM-LN at UK clinical sites.¹

Separately, the FDA cleared the company's IND application for FT839, a next-generation, off-the-shelf CAR T-cell product candidate uniquely engineered to co-target CD19 and CD38, in July.¹ The Phase 1/2 basket trial, called COMPLETE, is designed to evaluate FT839 across multiple autoimmune indications in combination with background therapy without the requirement for conditioning chemotherapy, with a starting dose level of 900 million cells.¹

In systemic sclerosis, preliminary data presented at ISSCR showed that as of the June 12, 2026 data cutoff, four patients had been treated, demonstrating a revised Composite Response Index in Systemic Sclerosis of 25 or higher and meaningful mean improvement in modified Rodnan Skin Score for all patients at three months, with no CRS, ICANS, GvHD, or hypogammaglobulinemia reported.¹

Financially, cash, cash equivalents, and investments as of June 30, 2026 were $153.8 million, a quarterly decrease of $21 million.¹ The company said its operating runway extends into 2028, driven by improvements to the expense structure of the organization, along with the $153.8 million in cash, cash equivalents, and investments.¹