Fate Therapeutics Initiates Potentially Registrational RECLAIM-LN Clinical Trial of FT819 for the Treatment of Lupus Nephritis
Rhea-AI Summary
Fate Therapeutics (NASDAQ:FATE) has initiated RECLAIM-LN (NCT07570862), a Phase 2 potentially registrational clinical trial of its off-the-shelf CAR T-cell therapy FT819 in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with lupus nephritis. The first patient was dosed in an outpatient setting and discharged the same day, and multiple patients are currently being screened at several activated sites.
The study is expected to enroll about 53 patients with Class III or IV lupus nephritis and aims to complete enrollment within 15–18 months, by the first half of 2028. Patients will receive a single 900 million-cell dose of FT819 after less-intensive conditioning with bendamustine. The primary endpoint is complete renal response at Week 26. According to Fate Therapeutics, the trial advances FT819 toward a potential accelerated regulatory pathway supported by RMAT designation and participation in the FDA CMC Development and Readiness Pilot program.
Positive
- Phase 2 RECLAIM-LN trial of FT819 initiated with first patient dosed
- Study plans to enroll approximately 53 patients with Class III or IV lupus nephritis
- Enrollment targeted for completion in 15–18 months, by 1H2028
- Single outpatient 900 million-cell dose regimen may support patient accessibility
- RMAT designation and FDA CMC pilot participation support a potential accelerated regulatory pathway
Negative
- None.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 06 | Clinical data presentation | Positive | +2.4% | Preliminary FT819 systemic sclerosis data scheduled for presentation at the ISSCR 2026 meeting |
| Jun 01 | Clinical data update | Positive | -3.5% | FT836 Phase 1 solid-tumor data showed early activity and favorable safety signals |
| Dec 08 | Clinical data update | Positive | -0.9% | Updated FT819 SLE data reported dose-level response reductions and favorable safety |
| Oct 26 | Clinical data update | Positive | -6.1% | Updated FT819 SLE data reported renal responses and low-grade CRS only |
| Jun 11 | Clinical data update | Positive | -7.2% | FT819 lupus nephritis data reported renal responses and drug-free remission |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Tag-specific clinical-trial announcements produced four negative price divergences and one positive alignment, despite consistently positive clinical descriptions.
Key Terms
rmატ designation regulatory
cmc development and readiness pilot program regulatory
car t-cell therapy medical
lupus nephritis medical
bendamustine medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
First patient dosed in an outpatient setting, discharged the same day; multiple patients in the process of screening at several activated sites
Trial advances FT819 toward a potential accelerated regulatory pathway supported by RMAT designation and participation in the FDA CMC Development and Readiness Pilot program
Study expected to enroll approximately 53 patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with Class III or IV lupus nephritis; study anticipated to complete enrollment in 15-18 months, by 1H2028
Patients to receive a single 900 million-cell dose of off-the-shelf FT819 following less-intensive conditioning with bendamustine; complete renal response at Week 26 is the primary endpoint
SAN DIEGO, Aug. 14, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients for broad accessibility, today highlighted the initiation of and treatment of the first patient in RECLAIM-LN (NCT07570862), its Phase 2 potentially registrational clinical trial of FT819 in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with lupus nephritis.
“The initiation of RECLAIM-LN and treatment of the first patient marks an important step in our effort to establish FT819 as a broadly accessible, off-the-shelf CAR T-cell therapy for patients with serious autoimmune disease,” said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. “The study design reflects our interactions with the FDA under FT819 RMAT designation and builds on the clinical activity, favorable safety profile and patient accessibility observed to date in our Phase 1 program. Early interest from investigators in the lupus nephritis community has been encouraging as we ramp up enrollment.”
About the RECLAIM-LN Phase 2 Clinical Trial
RECLAIM-LN (FT819-201; NCT07570862) is a multicenter Phase 2, open-label, single-arm trial designed to evaluate the efficacy and safety of FT819 in patients with refractory moderate-to-severe SLE with Class III or IV lupus nephritis (with or without concomitant class V). One of the most serious manifestations of SLE, lupus nephritis, is a leading driver of kidney failure among patients with lupus, many of whom have exhausted available immunosuppressive treatment options. The study is expected to enroll approximately 53 patients who are refractory to at least two prior systemic immunosuppressive therapies. The primary endpoint is the proportion of participants achieving complete renal response (CRR) at Week 26. Secondary endpoints include evaluation of CRR at later timepoints, overall and partial renal response, lupus low disease activity state, remission, quality of life measures, and other disease-related and patient-reported outcomes. Preliminary data from the Phase 1 study demonstrated favorable safety and tolerability and clinically meaningful improvement with sustained improvements across several disease activity measures, including clinical Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K and urine protein-to-creatinine ratio (UPCr). Both measures showed further reductions with the use of less-intensive bendamustine conditioning.
The RECLAIM-LN study was developed through interactions with the FDA under FT819 Regenerative Medicine Advanced Therapy (RMAT) designation. FT819 has also been selected for the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program, which provides opportunities for early and enhanced communication with the FDA regarding CMC readiness for therapies with accelerated clinical development timelines.
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 number: CLIN2-16303)
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, the initiation and continuation of enrollment in the Company’s clinical trials, the activation of clinical sites and the pace of patient screening and enrollment, the manufacture, release, distribution and availability of drug product supply, including the Company’s expectations regarding the adequacy of drug product inventory to support clinical trial demand, 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 that alignment with the FDA on potency or other CMC matters may not be maintained or may not result in acceptance of the Company’s approach at the time of a marketing application, the risk of a delay or difficulties in the manufacturing, release, or supply of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that clinical site activation and patient screening may not proceed as anticipated, 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
