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

Rhea-AI Summary

Fate Therapeutics (NASDAQ: FATE) presented updated Phase 1 data for off-the-shelf CAR T candidate FT819 and preclinical advances for FT836 and FT839 at ASH 2025. 13 patients enrolled (12 SLE, 1 SSc); 10 SLE patients had ≥1 month follow-up. FT819 showed progressive mean SLEDAI-2K score reductions (DL1: 50% at 3 months, 70% at 6 months; DL2: 65% at 3 months, 78% at 6 months [n=1 at 6 months]), durable B‑cell depletion, meaningful FACIT‑fatigue improvements, no Grade >2 CRS/ICANS/GVHD, and on‑demand dosing from inventory. Company plans to discuss a registrational trial for FT819 in 2026 under RMAT. Preclinical FT836/FT839 data show expanded antigen targeting and conditioning‑free approaches for hematologic and autoimmune indications.

Positive

• 13 patients enrolled across 14 activated clinical sites
• DL1 SLEDAI-2K down ~50% at 3 months, ~70% at 6 months
• DL2 SLEDAI-2K down ~65% at 3 months, ~78% at 6 months
• Durable B-cell depletion with reconstitution toward naïve cells
• No Grade >2 CRS, ICANS, or GVHD reported
• Company pursuing registrational FT819 study in 2026 under RMAT

Negative

• Only 10 SLE patients had ≥1 month follow-up
• DL2 6-month SLEDAI result is based on n=1
• DL1 6-month SLEDAI result is based on n=2

News Market Reaction

-0.93%

1 alert

-0.93% News Effect

On the day this news was published, FATE declined 0.93%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

SLE patients treated: 12 patients Total enrolled patients: 13 patients Activated clinical sites: 14 sites +5 more

8 metrics

SLE patients treated 12 patients FT819 Phase 1 basket trial as of Nov 25, 2025

Total enrolled patients 13 patients FT819 Phase 1 basket trial (12 SLE, 1 systemic sclerosis)

Activated clinical sites 14 sites FT819 trial (11 United States, 3 United Kingdom)

Dose level 1 360 million cells FT819 Regimen A dose level 1 (DL1)

Dose level 2 900 million cells FT819 Regimen A dose level 2 (DL2)

Clinical SLEDAI-2K remission 5 of 10 patients Clinical SLEDAI-2K score of 0 achieved in FT819 SLE cohort

Lupus nephritis CRR 2 patients Both lupus nephritis patients with >3‑month follow-up achieved CRR

Median prior therapies 7 therapies Baseline SLE disease burden in FT819 Phase 1 trial

Market Reality Check

Price: $1.18 Vol: Volume 732,164 is below t...

low vol

$1.18 Last Close

Volume Volume 732,164 is below the 20-day average of 1,302,783 (relative volume 0.56). low

Technical Price 1.08 is trading below the 200-day moving average of 1.14 and well under the 2.93 52-week high.

Peers on Argus

Peers show mixed moves: CRBP up 4.69%, EQ up 5.47%, while KALA is down 6.67%. Wi...

2 Up 1 Down

Peers show mixed moves: CRBP up 4.69%, EQ up 5.47%, while KALA is down 6.67%. With FATE down 2.26% pre-news and no same-day peer news, the setup appears stock-specific rather than a coordinated sector reaction.

Historical Context

5 past events · Latest: Nov 25 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 25	Conference appearance	Neutral	-1.9%	Upcoming presentation at a major healthcare investor conference.
Nov 13	Earnings and updates	Positive	-4.6%	Q3 2025 financials plus FT819 clinical and ex‑US expansion updates.
Nov 04	Inducement equity awards	Neutral	-5.6%	Equity grants to new non‑executive employees under inducement plan.
Oct 14	CFO appointment	Positive	+7.9%	Appointment of new CFO with extensive life‑sciences experience.
Oct 02	Inducement equity awards	Neutral	-3.2%	Stock options and RSUs granted to a newly hired employee.

Pattern Detected

Recent news flow shows mostly neutral-to-positive announcements, with one earnings update seeing a negative price reaction, but overall a mix of aligned and divergent moves.

Recent Company History

Over the last few months, Fate Therapeutics has focused on investor outreach, financial updates, and leadership changes. Events included a healthcare conference appearance on Dec 2, 2025, Q3 2025 results with FT819 clinical progress and projected cash runway through year-end 2027, recurring inducement equity awards under Nasdaq Listing Rule 5635(c)(4), and the appointment of a new CFO effective Oct 20, 2025. Today’s FT819 and next‑generation CAR T update extends this clinical narrative from lupus data toward broader autoimmune and oncology applications.

Market Pulse Summary

This announcement details updated Phase 1 FT819 data in SLE and systemic sclerosis, showing durable ...

Analysis

This announcement details updated Phase 1 FT819 data in SLE and systemic sclerosis, showing durable disease activity reductions, B‑cell depletion with immune reset features, and a differentiated safety profile without intensive conditioning. It also highlights new preclinical FT836 and FT839 programs targeting MICA/B, CD19, and CD38. Investors may track enrollment growth, additional autoimmune indications, RMAT‑driven FDA interactions, and how next‑generation multi‑antigen CAR T designs perform as key future milestones.

Key Terms

systemic lupus erythematosus, systemic sclerosis, chimeric antigen receptor, CAR T-cell, +4 more

8 terms

systemic lupus erythematosus medical

"FT819 continues to demonstrate meaningful decrease in disease... twelve systemic lupus erythematosus (SLE) patients"

Systemic lupus erythematosus is a chronic autoimmune disease in which the body's immune system mistakenly attacks healthy tissue, causing inflammation that can affect skin, joints, kidneys, heart, lungs and other organs. It matters to investors because disease severity, prevalence, and gaps in effective treatments drive demand for new drugs and diagnostics—think of it as a large, persistent market need where a successful therapy can change patient outcomes and create significant commercial value.

systemic sclerosis medical

"twelve systemic lupus erythematosus (SLE) patients now treated; first systemic sclerosis (SSc) patient treated"

Systemic sclerosis is a chronic autoimmune disease where the body's repair system overreacts, causing hardening and tightening of skin and internal organs much like scar tissue spreading beyond a wound. It matters to investors because it creates a clear medical need for new treatments, influences the size and urgency of clinical trials, and affects regulatory scrutiny, pricing power, and long-term healthcare costs tied to any therapy or diagnostic that proves effective.

chimeric antigen receptor medical

"FT836 chimeric antigen receptor (CAR) T cells uniquely targeting stress antigens MICA/B"

A chimeric antigen receptor is an engineered protein added to a patient’s immune cells that gives them a new, specific ability to recognize and attack cells carrying a particular marker (antigen) — like equipping police with a facial‑recognition app to find a suspect. For investors, CARs are the core technology behind targeted cell therapies: their clinical success, manufacturing complexity, safety profile, and regulatory approval determine treatment market potential, development costs, and company value.

CAR T-cell medical

"FT819 off-the-shelf CAR T-cell product candidate for systemic lupus erythematosus"

CAR T-cell therapy uses a patient’s own immune cells that have been removed, reprogrammed in a lab to recognize a specific marker on cancer cells, and returned to the body to seek and destroy tumors. Think of it as giving a person's white blood cells a custom-made 'GPS' that guides them to cancer cells. Investors watch CAR T-cell programs because they can command high prices, involve complex manufacturing and regulatory risk, and their clinical success or failure can sharply affect a biotech company's value.

MICA/B medical

"FT836 chimeric antigen receptor (CAR) T cells uniquely targeting stress antigens MICA/B"

MICA/B are proteins that appear on the surface of stressed, infected, or cancerous cells and act like warning flags that can trigger certain immune cells to attack. For investors, changes in MICA/B levels or drugs that alter their activity matter because they can indicate how well an immunotherapy or diagnostic might work, and they can affect clinical outcomes, regulatory approval chances, and the commercial value of related treatments.

monoclonal antibodies medical

"combination with monoclonal antibodies or T-cell engager further expands targeting capacity"

Monoclonal antibodies are lab-made proteins designed to bind a single, specific target on cells or viruses, like identical keys cut to fit one lock. They are used as medicines, tests, or targeted delivery tools and can precisely block or mark disease processes. Investors care because they can become high-value drugs with large sales, long patent protection, and binary risks tied to clinical trial results, regulatory approval, manufacturing scale and pricing.

cytokine release syndrome medical

"no Grade >2 CRS, ICANS, or GVHD were reported"

An intense immune overreaction in which the body's defense system releases a large surge of signaling proteins, causing fever, low blood pressure, breathing trouble or organ stress; imagine the immune system's alarm going into overdrive and flooding the body with emergency responders. Investors care because this side effect can slow or block regulatory approval, increase clinical trial costs and liabilities, limit how widely a therapy can be used, and therefore affect a drug's market value and sales potential.

Regenerative Medicine Advanced Therapy regulatory

"under its Regenerative Medicine Advanced Therapy (RMAT) designation regarding plans to initiate"

Regenerative Medicine Advanced Therapy (RMAT) is a U.S. regulatory designation for cell, gene, and tissue‑based therapies intended to treat serious or life‑threatening conditions; it gives developers a “fast lane” with more frequent agency interaction and eligibility for accelerated review pathways. For investors, an RMAT label signals that a therapy may reach market faster and face less regulatory uncertainty than a standard program, which can raise the potential value and reduce timeline risk—though it is not a guarantee of approval.

AI-generated analysis. Not financial advice.

FT819 continues to demonstrate meaningful decrease in disease and favorable safety profile with twelve systemic lupus erythematosus (SLE) patients now treated; first systemic sclerosis (SSc) patient treated

First ex-U.S. SLE patient treated with FT819 expands enrollment capacity and supports unique ability of FT819 for broad, on-demand patient accessibility

Preclinical studies show FT836 chimeric antigen receptor (CAR) T cells uniquely targeting stress antigens MICA/B, combined with daratumumab, provide a comprehensive approach to treatment of multiple myeloma

FT839 CAR T cells demonstrate the unique ability to treat a wide range of B-cell malignancies and autoimmune diseases through dual-CAR CD19/CD38 targeting without the need of conditioning chemotherapy in various preclinical models; combination with monoclonal antibodies or T-cell engager further expands targeting capacity

SAN DIEGO, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients for broad accessibility, presented updated clinical data from its ongoing Phase 1 trial evaluating its FT819 off-the-shelf iPSC-derived CAR T-cell program in systemic lupus erythematosus (SLE) and unveiled new preclinical data from next-generation off-the-shelf iPSC-derived CAR T-cell programs for hematologic malignancies and autoimmune diseases at the 2025 American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida.

“We are very pleased with the accelerating patient enrollment, the expansion of U.S. clinical sites, and the addition of international clinical sites, which together are enabling broader access to FT819 for patients suffering with lupus,” said Bob Valamehr, Ph.D., M.B.A., President and Chief Executive Officer of Fate Therapeutics. “The updated FT819 clinical data continue to demonstrate meaningful and durable responses with the use of less-intensive conditioning chemotherapy and a differentiated safety profile, reinforcing our goal to commence a registrational study for FT819 in 2026 and highlighting the potential of FT819 as an ideal CAR T-cell therapy for various autoimmune diseases. At the same time, our next-generation programs, FT836 and FT839, are showing substantial progress, with enhanced potency, functional persistence, and multifunctional engineering that are designed to extend the benefits of our platform across hematologic malignancies and solid tumors. These advances highlight the continued momentum of our iPSC-derived off-the-shelf CAR T-cell pipeline and our commitment to delivering scalable, on-demand and broadly accessible CAR T-cell therapies worldwide.”

The clinical update includes data from the Company’s ongoing Phase 1 basket trial of FT819, its lead product candidate, across 13 enrolled patients; 12 with SLE (10 of whom have at least one month of post-treatment follow-up) and one with systemic sclerosis. The updated results demonstrate sustained clinical responses, durable B-cell depletion in a potential dose-response manner, and a differentiated safety profile without the need for intensive-conditioning chemotherapy that typically consists of multiple days of combined doses of cyclophosphamide and fludarabine. With the strength of this clinical data, the Company continues to advance preparations for a pivotal study and is engaged in discussions with the United States Food and Drug Administration (FDA) under its Regenerative Medicine Advanced Therapy (RMAT) designation regarding plans to initiate registrational trial of FT819 in 2026.

At ASH, the Company also presented new preclinical data for two next-generation iPSC-derived CAR T-cell programs designed for use in both oncology and autoimmunity. These programs demonstrate substantial improvements in functional activity and persistence, drug product consistency and uniformity, and breadth of antigen-targeting mechanisms compared with existing autologous and in vivo CAR T-cell platforms.

FT819-102 Clinical Trial Update

FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product engineered to improve safety and efficacy. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master iPSC line serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to potentially reach a broad patient population.

As of a November 25, 2025 data cut off date, 12 SLE patients were treated by 5 enrolling clinical sites, with 14 clinical sites in total (11 in United States and 3 in United Kingdom) now activated. Baseline characteristics were consistent with a high disease burden patient population:

• median SLE duration was 8.7 years, median 7 prior therapies;

• median 14 Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (baseline range 8-20);

• mean 2.3±0.4 Physician Global Assessment (PGA); and

• mean 23±13 Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-Fatigue) score.

As of an October 22, 2025 data cut off date, 10 SLE patients had ≥ 1 month follow up, with 6 of the 10 patients having active lupus nephritis. Preliminary data in Regimen A (with patients receiving a single FT819 dose after pretreatment with either a single dose of cyclophosphamide or two doses of bendamustine) show mean SLEDAI-2K score across both dose levels (DL1, 360 million cells; DL2, 900 million cells) decreased progressively from baseline:

• 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), and to a mean of 6 at month 6 (n=2), representing mean percent drops of 50% and 70%, respectively; and

• 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) and to 4 at month 6 (n=1), representing mean percent drops of 65% and 78%, respectively.

Clinical SLEDAI-2K (excluding anti-dsDNA and complement) of 0 was achieved in 5 out of 10 patients, two of whom had resumed an immunosuppressive agent that had previously failed to achieve a clinical SLEDAI-2K of 0 prior to FT819. Two lupus nephritis patients had greater than 3-month follow up, with both achieving complete renal response (CRR) at 2 months and 6 months, respectively. FACIT-fatigue scores improved meaningfully for all patients who had more than one assessment. B-cell depletion was observed, with reconstitution towards predominately naïve cells within the first 3 months. There were no observed dose limiting toxicities; no Grade >2 CRS, ICANS, or GVHD were reported. All patients were treated with FT819 that was available on-demand.

Below are links to the Company Presentations at the 2025 ASH Annual Meeting & Exposition:

Saturday December 6, 2025

Targeting of tumor antigen CD38 and stress antigens MICA/B by CAR T cells provides a unique approach for the comprehensive treatment of multiple myeloma
Poster Presentation Number: 2350

Session Title: CAR-T Cell Therapies: Basic and Translational: Poster I

Session Time: 5:30 PM - 7:30 PM ET

Sunday December 7, 2025

Development of next generation multi-antigen targeting off-the-shelf CAR T cells for conditioning-free treatment of B-cell lymphoma
Poster Presentation Number: 4121

Session Title: CAR-T Cell Therapies: Basic and Translational: Poster II

Session Time: 6:00 PM - 8:00 PM ET

Monday December 8, 2025

The development of an off-the-shelf CAR T-cell therapy targeting CD19 and CD38 for broad application in autoimmune disease
Poster Presentation Number: 5895

Session Title: CAR-T Cell Therapies: Basic and Translational: Poster III

Session Time: 6:00 PM - 8:00 PM ET

About Fate Therapeutics’ iPSC Product Platform

Human induced pluripotent stem cells (iPSCs) possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s proprietary iPSC product platform combines multiplexed-engineering of human iPSCs with single-cell selection to create clonal master iPSC lines. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, the Company utilizes its clonal master iPSC lines as a starting cell source to manufacture at scale engineered cell products which are well-defined and uniform in composition, can be stored in inventory for off-the-shelf availability, can be administered in combination with other therapies, and can potentially reach a broad patient population. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with patient- and donor-sourced cell therapies. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 500 issued patents and 500 pending patent applications.

About Fate Therapeutics, Inc.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company's product candidates, clinical studies and preclinical research and development programs, the Company’s progress, plans and timelines for the clinical investigation of its product candidates, including the Company’s plans to complete IND-enabling studies and to submit IND applications for its product candidates, the initiation and continuation of enrollment in the Company’s clinical trials, the expansion of the Company’s ongoing and planned clinical trials to enroll additional patients and include additional clinical sites, the initiation of additional clinical trials, including in new indications, and additional dose cohorts in ongoing clinical trials of the Company’s product candidates, the availability of data from the Company’s clinical trials and the Company’s plans to provide updates on its clinical trials, the therapeutic and market potential of the Company’s research and development programs and product candidates, and the Company’s clinical and product development strategy. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Contact:
Christina Tartaglia
Precision AQ
212.362.1200
christina.tartaglia@precisionaq.com

Source: Fate Therapeutics, Inc.

FAQ

What Phase 1 FT819 data did Fate Therapeutics (FATE) present on Dec 8, 2025?

Updated Phase 1 data showing SLEDAI-2K score reductions, durable B-cell depletion, improved fatigue scores, and no Grade >2 CRS/ICANS/GVHD.

How many patients were treated with FT819 in the December 2025 update for FATE?

13 patients were enrolled overall: 12 with SLE and 1 with systemic sclerosis, with 10 SLE patients having ≥1 month follow-up.

What were the FT819 dose levels and key SLEDAI-2K results reported by FATE?

DL1 was 360 million cells and DL2 was 900 million cells; DL1 showed ~50% SLEDAI drop at 3 months and ~70% at 6 months; DL2 showed ~65% at 3 months and ~78% at 6 months (6-month DL2 n=1).

Did the FT819 trial report serious CAR T toxicities in the FATE update?

No Grade >2 cytokine release syndrome, ICANS, or graft‑versus‑host disease were reported in the update.

What regulatory step is Fate pursuing for FT819 after the ASH 2025 update?

Fate is engaged with the FDA under RMAT and plans to initiate a registrational FT819 study in 2026.

What preclinical advances did Fate announce for FT836 and FT839 at ASH 2025?

FT836 targets MICA/B stress antigens combined with daratumumab for multiple myeloma; FT839 dual‑CAR CD19/CD38 shows conditioning‑free targeting across B‑cell malignancies and autoimmune models.