Fate Therapeutics Presents Updated Preliminary Data for FT819 in Active Lupus Nephritis at American Society of Nephrology Kidney Week 2026

The Phase 2 conditioning regimen produced Month 6 renal responses in two evaluable patients, alongside reported infections and cytopenias.

Rhea-AI Summary

Fate Therapeutics (FATE) presented preliminary FT819 Phase 1 lupus nephritis data showing renal responses in both patients evaluable after bendamustine conditioning. At the August 18, 2026 cutoff, these patients achieved complete or primary efficacy renal responses at Month 6, with an approximately 50% mean reduction in urine protein-to-creatinine ratio, a measure of kidney damage. Immunosuppressants were discontinued; hydroxychloroquine and low-dose prednisone were permitted. One patient's complete response persisted through Month 24.

Across 29 autoimmune patients, no dose-limiting toxicity or deaths occurred. Low-grade cytokine release syndrome occurred in five patients; Grade ≥3 infections and low blood-cell counts occurred in two and six patients, respectively. The ongoing, potentially registrational Phase 2 RECLAIM-LN study uses the same bendamustine conditioning regimen in refractory, moderate-to-severe lupus with nephritis.

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Positive

• Minor pointMonth 6 renal response was 100% in two evaluable active lupus nephritis patients receiving FT819 plus bendamustine.
• Minor pointMean urine protein-to-creatinine ratio decreased approximately 50% from baseline at Month 6 in those two patients.
• Minor pointComplete renal response persisted through Month 24 in the single patient reaching that follow-up.
• Minor pointNo dose-limiting toxicity or deaths occurred across 29 autoimmune patients receiving single-dose FT819 with less-intensive conditioning.
• Minor pointNo neurological toxicity, graft-versus-host disease or immune-cell-associated hyperinflammatory syndrome was reported across 29 treated autoimmune patients.

9 minor points

• Minor pointNo cytokine release syndrome above Grade 2 occurred across 29 treated autoimmune patients.
• Minor pointClinical lupus disease-activity scores declined as early as Month 1 in active nephritis patients and the overall lupus population.
• Minor pointPhysician-rated lupus disease activity fell approximately 75% from baseline by Month 6.
• Minor pointPatient-reported fatigue scores improved 2-fold from baseline by Month 6, moving beyond the moderate-to-severe fatigue range.
• Minor pointDurable B-cell depletion occurred in 11 patients, with activity in secondary lymphoid tissue observed in three.
• Minor pointB-cell recovery shifted toward naïve cells at Month 6 in five patients, with fewer class-switched memory cells.
• Minor pointThe 50 most abundant baseline B-cell clones were absent by Month 1 and did not re-emerge through Month 6.
• Minor pointPhase 2 RECLAIM-LN is ongoing, using bendamustine conditioning in refractory, moderate-to-severe lupus with nephritis.
• Minor pointOutpatient FT819 administration is occurring in the U.S.

Negative

• Moderate pointGrade ≥3 low blood-cell counts occurred in six patients (20.7%) across the 29-patient autoimmune safety population.
• Minor pointSelected-regimen Month 6 efficacy data are preliminary and cover only two evaluable active lupus nephritis patients.
• Minor pointGrade ≥3 infections occurred in two patients (6.9%), both urinary tract infections.
• Minor pointGrade 1–2 cytokine release syndrome occurred in five patients (17.2%), an inflammatory treatment reaction.

News Explained

Beyond renal-response results, the update adds disease-activity, fatigue and B-cell observations to the ongoing Phase 1 evidence.

Fate Therapeutics presented updated preliminary FT819 Phase 1 data at Kidney Week 2026; the reported cutoff was August 18, 2026, and both the Phase 1 study and RECLAIM-LN Phase 2 study are ongoing. The update adds results from a broader conditioning cohort to the reported renal-response evidence.

In Regimen A, which used FT819 with cyclophosphamide or bendamustine, among six Class III/IV lupus nephritis patients, with or without Class V, followed to Month 6, 50% achieved a complete renal response and 50% achieved a primary efficacy renal response.

The presentation also reported that disease-activity scores declined as early as Month 1, Physician Global Assessment fell approximately 75% by Month 6, and mean fatigue scores improved twofold, moving out of the moderate-to-severe range.

It also reported durable B-cell depletion followed by reconstitution with more naïve and fewer class-switched memory B cells; the 50 most abundant baseline B-cell clones were absent by Month 1 and did not reappear through Month 6.

Key Figures

Renal response: 100% Proteinuria reduction: approximately 50% Grade 1–2 CRS: 5 patients (17.2%) +5 more

Renal response

100%

Active LN patients receiving FT819 with bendamustine; Month 6 follow-up, n=2

Proteinuria reduction

approximately 50%

Mean reduction from baseline at Month 6 in the active LN bendamustine cohort, n=2

Grade 1–2 CRS

5 patients (17.2%)

Autoimmune patients treated with a single dose of FT819

Grade ≥3 infections

2 patients (6.9%)

Both reported infections were urinary tract infections

Grade ≥3 cytopenias

6 patients (20.7%)

Autoimmune patients treated with a single dose of FT819

PGA score reduction

approximately 75%

From baseline by Month 6

Fatigue score improvement

2-fold

FACIT-Fatigue from baseline by Month 6

Renal response in broader cohort

50%

Regimen A Class III/IV LN patients with Month 6 follow-up, n=6

Historical Context

1 past event · Latest: Sep 25

1 event

1. Sep 25

   Grant award

   24h Move

   +0.9%

   CIRM awarded $15.0 million to support FT819's Phase 2 RECLAIM-LN development.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

lupus nephritis, proteinuria, car t-cell, cytokine release syndrome, +1 more

5 terms

lupus nephritis medical

"patients with systemic lupus erythematosus (SLE) with lupus nephritis (LN)"

Lupus nephritis is a condition in which a person’s immune system attacks the kidneys, causing inflammation and damage to the organs’ filtering function and leading to blood or protein in the urine and, in severe cases, kidney failure. For investors, it defines a specific, medically serious patient group and treatment need: success or failure of therapies, clinical trials, regulatory approvals, and pricing decisions for drugs aimed at this condition can meaningfully change a biotech or pharma company’s revenue prospects — like fixing a costly, central leak in a building that determines the value of the whole property.

proteinuria medical

"approximately 50% mean reduction in proteinuria"

Proteinuria is when abnormal amounts of protein are found in a person's urine. It can be a sign that the kidneys aren't working properly, since healthy kidneys usually prevent most proteins from passing into urine. Detecting proteinuria helps doctors identify and monitor kidney problems early.

car t-cell medical

"anti-CD19 CAR T-cell product candidate"

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.

cytokine release syndrome medical

"no cytokine release syndrome (CRS) above Grade 2 was observed"

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.

icans medical

"No immune effector cell-associated neurotoxicity syndrome (ICANS)"

ICANS (Immune effector Cell-Associated Neurotoxicity Syndrome) is a range of brain-related side effects that can occur after certain immune-cell cancer therapies, such as CAR-T. Symptoms can include confusion, speech problems, seizures or reduced consciousness, and they are caused by an overactive immune response affecting the brain. Investors care because ICANS can influence patient safety, trial outcomes, regulatory approvals, treatment labeling and adoption, all of which affect a therapy’s commercial prospects and development costs.

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Active LN patients in the Phase 1 study treated with FT819 and the less-intensive conditioning (bendamustine) regimen selected for the RECLAIM-LN study achieved 100% renal response at Month 6, with approximately 50% mean reduction in proteinuria

Encouraging safety profile with no dose-limiting toxicities, high-grade CRS, ICANS, GvHD or IEC-HS in autoimmune patients treated with a single dose of FT819; low incidences of infection and cytopenia were also observed

Clinical data reinforces the patient value of the ongoing RECLAIM-LN, a Phase 2 potentially registrational study of FT819 in refractory, moderate-to-severe SLE with LN

FT819 continues to offer a unique product profile with the simplicity to dose CAR T-cell therapy on-demand in the community setting

SAN DIEGO, Oct. 26, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative and broadly accessible pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today announced updated Phase 1 clinical data for FT819, its off-the-shelf, available on-demand, anti-CD19 CAR T-cell product candidate, in patients with systemic lupus erythematosus (SLE) with lupus nephritis (LN) were featured in an oral presentation at the American Society of Nephrology (ASN) Kidney Week 2026, held October 22–25 in Denver, Colorado.

The oral presentation, "Off-the-Shelf Anti-CD19 Chimeric Antigen Receptor (CAR)-T Cell Therapy with Less-Intensive Fludarabine-Free Conditioning in Lupus Nephritis: Phase 1 Safety and Efficacy," was presented on October 24, 2026, by Jonathan D. Graf, MD, Professor of Clinical Medicine, Division of Rheumatology at the University of California, San Francisco. The presentation reported data from the ongoing Phase 1 FT819-102 study as of the August 18, 2026, data cutoff.

“While these results are early, the initial efficacy and, even more importantly, the safety seen with FT819 is extremely promising,” said Dr. Graf. “In this Phase 1 study, patients receiving even the lowest doses of FT819 are achieving significant clinical responses while showing no signs of serious toxicity. I am extremely excited to see the full results from this study once it is completed and look forward to the Phase 2 trial in LN.”

Across all 29 autoimmune patients, including those with SLE, treated with a single dose of FT819 following less-intensive, fludarabine-free conditioning, FT819 was well tolerated, supporting outpatient administration and expanded patient access. In a cohort of patients with active LN treated with FT819 and bendamustine conditioning, while discontinuing immunosuppressant medications - the regimen selected for the ongoing Phase 2 RECLAIM-LN study - all patients evaluable at Month 6 either achieved a complete renal response (CRR) or primary efficacy renal response (PERR). These outcomes were accompanied by meaningful improvements in lupus disease activity, significant reductions in fatigue, and strong evidence of B-cell reset and remodeling.

“While preliminary, the Phase 1 lupus nephritis clinical efficacy data, concurrent with the discontinuation of standard of care medication such as immunosuppressants, combined with favorable safety data across all patients treated with a single dose of FT819 and less-intensive conditioning, continues to be very encouraging and builds further confidence and momentum in our ongoing RECLAIM-LN study, a Phase 2 potentially registrational trial,” said Bob Valamehr, Ph.D., M.B.A., President and Chief Executive Officer of Fate Therapeutics. “The observed renal responses and favorable safety profile are also complemented with meaningful decreases in lupus disease activity scores and importantly, significant improvement in fatigue scores, a quality-of-life improvement aspect often not achieved with currently approved therapies in lupus nephritis. To be able to deliver such results in an outpatient setting with the on-demand availability of FT819 for broadened patient access is a game changer for patients with this challenging disease who currently lack good treatment options.”

Key findings from the presentation include:

Safety profile – all patients treated (N=29) with a single dose of FT819 with less-intensive conditioning:

• Favorable safety and tolerability supportive of outpatient delivery. All patients tolerated FT819 with less-intensive conditioning without a dose-limiting toxicity. No immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease (GvHD), immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS), or deaths were reported, and no cytokine release syndrome (CRS) above Grade 2 was observed. Low-grade (Grade 1–2) CRS occurred in 5 patients (17.2%). Grade ≥3 infections occurred in 2 patients (6.9%), both urinary tract infections, and Grade ≥3 cytopenias occurred in 6 patients (20.7%). In the U.S., FT819 is being administered in the outpatient setting.
  

Summary of efficacy and translational data from Phase 1 FT819-102 study as of a data cut-off date of August 18, 2026:  

• Selected Phase 2 conditioning regimen shows 100% renal response of CRR or PERR and approximately 50% mean reduction in proteinuria at Month 6 in active LN. Patients who were treated with FT819 plus bendamustine and discontinued standard of care therapy per study protocol (hydroxychloroquine and low-dose prednisone permitted) and who had follow up to Month 6 (n=2) achieved a complete renal response (CRR) or primary efficacy renal response (PERR), and mean urine protein-to-creatinine ratio (UPCr), a key measure of kidney damage in LN, decreased by approximately 50% from baseline. The renal response of CRR was sustained through Month 24 in the single patient to reach this timepoint as of the data cutoff date.
• LN patients in Regimen A show 50% renal response at Month 6. In the broader conditioning cohort, Regimen A (administration of FT819 with less-intensive conditioning consisting of either cyclophosphamide or bendamustine), 50% of Class III or Class IV with or without concomitant Class V LN patients with follow up to Month 6 (n=6) achieved CRR and PERR, respectively. Per study protocol, patients discontinued immunosuppressant medications (hydroxychloroquine and low-dose prednisone permitted) prior to treatment with FT819.
• Clinically meaningful improvements in disease activity and fatigue. Clinical SLEDAI-2K scores declined as early as Month 1 in both patients with active LN and the overall SLE population (n=11), with reductions maintained in patients with longer follow-up. Physician Global Assessment (PGA), a clinician-rated measure of overall lupus disease activity, fell by approximately 75% from baseline by Month 6. Patient-reported fatigue, measured by FACIT-Fatigue, improved 2-fold from baseline by Month 6, with mean scores moving out of the range associated with moderate-to-severe fatigue.
• Deep B-cell depletion followed by reconstitution of naïve B cells. FT819 drove durable B-cell depletion (n=11), and concurrently targeted B cells in secondary lymphoid tissue (n=3), indicating activity beyond peripheral blood. During the subsequent B-cell reconstitution, the emerging population reached normal levels for many patients and shifted toward a less-differentiated state at Month 6, with a higher proportion of naïve B cells and a lower proportion of class-switched memory B cells (n=5).
• Elimination of the top B-cell clones. The 50 most abundant B-cell receptor clones present at baseline were seen to be absent by Month 1 post FT819 treatment and did not re-emerge through Month 6. The elimination of these baseline dominant clones, which may include proliferating disease-driving autoreactive B cells, combined with the reconstitution of a naïve B-cell population, reinforces the remodeling of the B-cell compartment and is suggestive of an immune reset post FT819 treatment.
• Expanded patient reach and accessibility. FT819 is manufactured from a clonal master cell bank, produced at low cost of goods and is available on demand, with no need to collect and manufacture patient's own cells, further eliminating patient burden and risk. Combined with less-intensive conditioning that avoids fludarabine, which is cleared by the kidneys and requires dose adjustment in patients with impaired renal function, treatment with FT819 could broaden access to CAR T-cell therapy for patients with LN.

These data support the advancement of FT819 into the ongoing Phase 2 RECLAIM-LN study (FT819-201; NCT07570862) in patients with refractory, moderate-to-severe SLE with lupus nephritis, which uses the same bendamustine conditioning regimen.

About FT819

FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product candidate engineered to improve safety and efficacy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank 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 enable access for a broad patient population. This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state agency in California that supports research in regenerative medicine, stem cell therapy, gene therapy, and clinical trials. (Grant numbers: CLIN2-16303 and CLIN2-20291)

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 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 initiation and continuation of enrollment in the Company’s clinical trials, 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, the Company’s clinical and product development strategy, and the Company’s progress and plans relating to, and the anticipated timing and outcome of, interactions with the FDA and other regulatory authorities. 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, failure to demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, and risks relating to regulatory interactions and the outcome of such interactions. 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:

Ryan Douglas
Fate Therapeutics, Inc.
IR@fatetherapeutics.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Fate Therapeutics report for FT819 in lupus nephritis at Month 6?

Both evaluable active lupus nephritis patients receiving FT819 with bendamustine achieved a complete or primary efficacy renal response at Month 6. Mean urine protein-to-creatinine ratio decreased approximately 50% from baseline. Patients discontinued standard-of-care therapy under the protocol, although hydroxychloroquine and low-dose prednisone were permitted.

What safety findings did Fate Therapeutics report for FT819?

Across 29 autoimmune patients, no dose-limiting toxicity, deaths or cytokine release syndrome above Grade 2 occurred. Grade 1–2 cytokine release syndrome occurred in five patients (17.2%). Grade ≥3 infections occurred in two patients (6.9%), both urinary tract infections, and Grade ≥3 low blood-cell counts occurred in six patients (20.7%).

Why is Fate Therapeutics using fludarabine-free conditioning for FT819 in lupus nephritis?

The company says avoiding fludarabine could broaden access for lupus nephritis patients because the drug is cleared by the kidneys and requires dose adjustment in patients with impaired kidney function. The ongoing Phase 2 RECLAIM-LN study uses bendamustine conditioning.