Fate Therapeutics (FATE) Leerink Global Healthcare Conference 2026 summary

Program overview and technology

• FT819 is an off-the-shelf, allogeneic CAR T-cell therapy derived from a master cell bank, enabling production of over 10 million uniform doses per bank.

• The product is designed for consistency and safety, with engineered CD8 T-cells targeting CD19, and a controlled expansion profile to balance efficacy and safety.

• FT819’s CAR design includes mutations in the CD3ζ signaling domain to reduce uncontrolled expansion, optimizing safety especially for autoimmune indications.

• The therapy is being advanced for lupus nephritis, renal lupus, myositis, systemic sclerosis, and vasculitis.

Clinical progress and data

• Nearly 70 patients have been treated, with consistent safety and efficacy results across batches.

• In aggressive DLBCL, FT819 showed a 40% complete response rate but lacked durability due to high tumor burden; better durability observed in lower-burden diseases.

• In lupus nephritis, the first two patients with six-month follow-up achieved complete renal response, with additional data expected at upcoming conferences.

• The therapy is administered in an outpatient setting, improving accessibility and reducing hospitalization time.

• Safety profile includes no ICANS, no GVHD, and only low-grade CRS, with significant improvements in patient-reported outcomes.

Regulatory and trial plans

• FT819 is under RMAT designation, with a phase II pivotal trial in lupus nephritis planned for the second half of the year, focusing on complete renal response as the primary endpoint.

• Approximately 25 lupus patients are expected to be treated by summer, with about 15 having six-month follow-up; half are lupus nephritis cases.

• Discussions with the FDA are ongoing regarding endpoints for extra-renal lupus, considering SRI-4 and DORIS as potential measures.

• The company is also exploring a regimen with no conditioning, adding FT819 to maintenance therapy, aiming for broader applicability and easier integration with standard care.