FT-819 Drug Asset Due Diligence Report 2026

This FT-819 Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.

Decision date: 18 September 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.

Phase 2

Highest phase

Registered trials

Result records

Matched deals

Executive recommendation: CONDITIONAL GO

Decision memo

Advance with milestone-based economics while efficacy durability, safety differentiation, patent scope, and market positioning are validated.

The central underwriting question is whether FT-819 can convert its Universal CAR-T, Induced pluripotent stem cells (iPSC) profile and CD19 biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	FT-819 (query alias: FT-819)
Modality / target	Universal CAR-T, Induced pluripotent stem cells (iPSC); CD19; CD19 inhibitors
Highest global status	Phase 2
Originator	Fate Therapeutics, Inc.
Active developers	Fate Therapeutics, Inc.

The MCP disease footprint includes Lupus Nephritis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Idiopathic Inflammatory Myopathies. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.

2. Clinical program: design and endpoint audit

Registry	Phase	Status	Enrollment	Lead primary endpoint
NCT07570862	Phase 2	Recruiting	53	Primary endpoint not disclosed in English source
NCT06308978	Phase 1	Recruiting	244	Primary endpoint not disclosed in English source
NCT04629729	Phase 1	Active, not recruiting	54	Primary endpoint not disclosed in English source

The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.

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3. Clinical readouts: what is known

Fate Therapeutics Presents Updated Phase 1 Clinical Data of FT819 Off-the-shelf CAR T-cell Product Candidate for Systemic Lupus Erythematosus and Preclinical Advances in Next-Generation Off-the-Shelf CAR T-cell Programs

Phase 1; n=12; evaluation: Positive. Reported fields: SLEDAI-2K(percent change at month 3) = DL1: SLEDAI-2K score decreased from a mean of 15.2 (n=5) at baseline to a mean of 10 at month 3 (n=2). DL2: SLEDAI-2K score decreased from a mean of 14.3 (n=3) at baseline to a mean of 6 at month 3 (n=2). % ; SLEDAI-2K(percent change at month 3) = -50 %

Longitudinal Analysis of B cell Remodeling in Systemic Lupus Erythematosus Following iPSC-Derived CAR T-cell Therapy

Phase 1; n=12; evaluation: Positive. Reported fields: BCR(class-switched) = 73.1 %

Fate Therapeutics Presents 6-Month Follow-up Data on First Patient Treated in Phase 1 Autoimmunity Study with Fludarabine-free Conditioning and FT819 Off-the-shelf, 1XX CAR T-cell Product Candidate at ACR Convergence

Phase 1; n=3; evaluation: Positive. Reported fields: SAE = None

These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.

4. Market and competitive position

FT-819 addresses Lupus Nephritis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Idiopathic Inflammatory Myopathies. Commercial attractiveness rests on addressable patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Universal CAR-T, Induced pluripotent stem cells (iPSC)—must demonstrate a benefit large enough to offset class-specific safety and operational costs.

The MCP screen returned 1 matched transaction record(s) under the scope “asset-specific.” Partner activity is a market-validation signal, but it does not establish net present value.

5. Transaction precedent and economics

Date	Transaction	Phase at deal	Disclosed economics
2018-05-16	Fate Therapeutics and Memorial Sloan Kettering Cancer Center Expand Scope of License Agreement to include Gene-edited T-cell Immunotherapies	Not disclosed	Financial terms not disclosed

Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.

6. IP and freedom-to-operate screen

No asset-specific patent-application milestone appeared in the returned milestone slice. That absence is not a freedom-to-operate conclusion; a dedicated family, claim, ownership, expiry, and legal-status search remains mandatory before signing.

The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights.

7. Principal risks and diligence gates

Cytokine-release syndrome, neurotoxicity, infection, and treatment logistics
Durability of response and antigen escape
Manufacturing scalability, release testing, and site readiness

Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.

8. Final go/no-go memorandum

CONDITIONAL GO