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Fate Therapeutics
Fate Therapeutics (FATE) investor relations material
Fate Therapeutics Leerink Global Healthcare Conference 2026 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Leerink Global Healthcare Conference 2026 summary9 Mar, 2026
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.
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Next Fate Therapeutics earnings date
Q1 202614 May, 2026
Fate Therapeutics
Next Fate Therapeutics earnings date
Q1 202614 May, 2026
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Fate Therapeutics, Inc., a clinical-stage biopharmaceutical company, develops programmed cellular immunotherapies for cancer and immune disorders worldwide. Fate Therapeutics, Inc. was incorporated in 2007 and is headquartered in San Diego, California.
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