Lupus NephritisPhase 2RECLAIM-LNNCT07570862
A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis
A Phase 2 study testing FT819 in people with Lupus Nephritis and Systemic Lupus Erythematosus, run by Fate Therapeutics at 12 sites in United States.
Trial summary
The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory moderate-to-severe lupus nephritis, as assessed by the proportion of participants who achieve… Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Lupus Nephritis, Systemic Lupus Erythematosus, SLE - Systemic Lupus Erythematosus
- What is being tested?
- FT819
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 12 sitesUnited States
- Study dates
- 27 Jul 2026to 31 Jan 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥12 to ≤70 years
- Diagnosis of SLE per EULAR/ACR 2019 classification criteria
- Biopsy-proven proliferative Class III or IV LN, with or without concomitant Class V involvement, based on the 2003/2018 ISN/RPS classification
- Positivity for at least one of the following autoantibodies at screening:
- Antinuclear antibody (ANA)
- Anti-double-stranded DNA (anti-dsDNA) or
Show all 10Show fewer
- Anti-Smith antibody
- Active disease, defined as:
- Evidence of SLE activity, defined as either: i. SLEDAI-2K ≥6 or ii. At least 1 BILAG A or 2 BILAG B scores for SLE-related organ involvement; and b. Evidence of renal involvement, defined as UPCr ≥1 g/g; and c. Moderate-to-severe renal disease with investigator's impression that improvement is possible
- Refractory to ≥2 systemic immunosuppressive therapies for the treatment of LN
Who cannot join
- Evidence of inadequate organ function during the screening period
- Active central nervous system (CNS) symptoms attributable to autoimmune disease within 12 months prior to trial intervention
- History of or current renal diseases (other than LN) that, in the opinion of the investigator, could interfere with assessment of LN or confound evaluation of disease activity
- Receipt of dialysis (hemodialysis or peritoneal dialysis) within 12 weeks of trial intervention
- Irreversible organ damage related to underlying disease (e.g., ESRD) where, in the opinion of the investigator, CD19 CAR T-cell therapy would be unlikely to benefit the participant
- History of malignancy in the prior 5 years
Show all 10Show fewer
- Known allergy to the following FT819 components: albumin (human) or DMSO
- History of intolerance or contraindication to bendamustine
- Body weight <30 kg
- Any medical condition, clinical laboratory abnormality, or nonmedical/social issue that, per investigator or medical monitor judgement, precludes safe participation in and completion of the trial or that could affect compliance with protocol conduct or interpretation of results
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Natalie Shiff, MD contact
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Wallace Rheumatic Studies Center
Beverly Hills, California, 90210
- Recruiting
GNP Research
Cooper City, Florida, 33024
- Recruiting
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
Cross Creek Medical Clinic
Fayetteville, North Carolina, 28304
- Recruiting
Kaiser Permanente Fontana
Fontana, California, 92335
- Recruiting
Providence Medical Foundation
Fullerton, California, 92835
- Recruiting
University of Florida Clinical Research Center
Gainesville, Florida, 32610
- Recruiting
University of California Irvine
Irvine, California, 92868
- Recruiting
Miami Dermatology and Laser Research
Miami, Florida, 33133
- Recruiting
Nicklaus Children's Hospital
Miami, Florida, 33155
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68105
- Recruiting
University of California San Francisco
San Francisco, California, 64110
About this study
Official title: A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Refractory Moderate-to-Severe Systemic Lupus Erythematosus With Lupus Nephritis (RECLAIM-LN)
The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory moderate-to-severe lupus nephritis, as assessed by the proportion of participants who achieve complete renal response (CRR) at Week 26.
Read the detailed description
This is a multicenter, phase 2 single-arm trial designed to evaluate the efficacy and safety of FT819 in participants with moderate-to-severe systemic lupus erythematosus (SLE) with Class III/IV lupus nephritis (LN) (with or without concomitant Class V involvement) refractory to at least 2 immunosuppressive therapies prior to trial intervention.
Participants will undergo a screening period of up to 28 days. Following screening, trial intervention will consist of bendamustine administration followed by a single dose of FT819. Efficacy, safety, and exploratory assessments will be conducted at predefined timepoints through Month 24 of post-treatment follow-up (PTFU). Following completion of these scheduled assessments, participants will continue in long-term follow-up (LTFU) for up to 15 years after FT819 administration to monitor ongoing safety and survival.
Efficacy and disease activity will be assessed using standard LN measures, including complete renal response (CRR) and PRR (partial renal response), as well as clinician-reported outcomes, such as the SLEDAI-2K, BILAG, and PGA, performed at specified timepoints.
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus, SLE - Systemic Lupus Erythematosus, Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV
- Being tested
- FT819
- Keywords
- FT819, Fate Therapeutics, Allogeneic CAR T, CD19 - targeted therapy, Lupus Nephritis, Systemic Lupus Erythematosus
- Medical subject headings
- Lupus Nephritis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT819Biological
Single Intravenous (IV) infusion of FT819 administered on Day 1
| Study group | Role | What they receive |
|---|---|---|
| FT819 | Experimental | FT819, allogeneic T cells derived from a clonal, TCR knockout iPSC line that express CD19-targeted CAR regulated by the TRAC locus, given as a single IV infusion Receives: Biological: FT819 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Renal Response (CRR) at Week 26
Proportion of participants achieving CRR at Week 26, with CRR defined as the achievement of all of the following criteria:
- UPCR <0.5 g/g
- Estimated glomerular filtration rate (eGFR) ≥85% of baseline or ≥60 mL/min/1.73 m2
- No use of rescue therapy
Measured: Week 26
Secondary outcomes (8)
CRR at Week 52
Proportion of participants who achieve CRR at Week 52
Measured: Week 52
CRR at Week 104
Proportion of participants who achieve CRR at Week 104
Measured: Week 104
Overall Renal Response
Proportion of participants who achieve an overall renal response, defined as achievement of either CRR or partial renal response (PRR), evaluated at Week 26, Week 52, and Week 104
Measured: Up to approximately 2 years
Proportion of participants who achieve PRR at Week 26, Week 52, and Week 104
PRR is defined as achievement of all of the following:
- ≥50% reduction in UPCr from baseline and to <3 g/g if baseline UPCr ≥3 g/g
- eGFR ≥80% of baseline or ≥60 mL/min/1.73 m2
- No use of rescue therapy
Measured: Up to approximately 2 years
Lupus Low Disease Activity State (LLDAS)
Proportion of participants who achieve lupus low disease activity state (LLDAS) at Week 26, Week 52, and Week 104
Measured: Up to approximately 2 years
Definition of Remission in SLE (DORIS)
Proportion of participants who achieve a definition of remission in SLE (DORIS) at Week 26, Week 52, and Week 104
Measured: Up to approximately 2 years
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (adults age ≥18 years) score at Week 26, Week 52, and Week 104
Measured: Up to approximately 2 years
Proportion of participants who achieve SLE Responder Index-4 (SRI-4)
Proportion of participants who achieve SLE Responder Index-4 (SRI-4) at Week 26, Week 52, and Week 104
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start27 Jul 2026
- Primary completion1 Jul 2029 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, single group assignment, open-label
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fate Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570862
- Sponsor's protocol ID
- FT819-201
- Acronym
- RECLAIM-LN
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Refractory Moderate-to-Severe Systemic Lupus Erythematosus With Lupus Nephritis (RECLAIM-LN)
- ClinicalTrials.gov ID
- NCT07570862
- Acronym / sponsor ID
- RECLAIM-LN / FT819-201
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus, SLE - Systemic Lupus Erythematosus, Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV
- Keywords
- FT819, Fate Therapeutics, Allogeneic CAR T, CD19 - targeted therapy, Lupus Nephritis, Systemic Lupus Erythematosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Fate TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory moderate-to-severe lupus nephritis, as assessed by the proportion of participants who achieve complete renal response (CRR) at Week 26.
Detailed description
This is a multicenter, phase 2 single-arm trial designed to evaluate the efficacy and safety of FT819 in participants with moderate-to-severe systemic lupus erythematosus (SLE) with Class III/IV lupus nephritis (LN) (with or without concomitant Class V involvement) refractory to at least 2 immunosuppressive therapies prior to trial intervention.
Participants will undergo a screening period of up to 28 days. Following screening, trial intervention will consist of bendamustine administration followed by a single dose of FT819. Efficacy, safety, and exploratory assessments will be conducted at predefined timepoints through Month 24 of post-treatment follow-up (PTFU). Following completion of these scheduled assessments, participants will continue in long-term follow-up (LTFU) for up to 15 years after FT819 administration to monitor ongoing safety and survival.
Efficacy and disease activity will be assessed using standard LN measures, including complete renal response (CRR) and PRR (partial renal response), as well as clinician-reported outcomes, such as the SLEDAI-2K, BILAG, and PGA, performed at specified timepoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, single group assignment, open-label
| Arm | Type | Receives |
|---|---|---|
| FT819 | Experimental | Biological: FT819FT819, allogeneic T cells derived from a clonal, TCR knockout iPSC line that express CD19-targeted CAR regulated by the TRAC locus, given as a single IV infusion |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥12 to ≤70 years
- Diagnosis of SLE per EULAR/ACR 2019 classification criteria
- Biopsy-proven proliferative Class III or IV LN, with or without concomitant Class V involvement, based on the 2003/2018 ISN/RPS classification
- Positivity for at least one of the following autoantibodies at screening:
- Active disease, defined as:
Key exclusion criteria (10 listed)
- Evidence of inadequate organ function during the screening period
- Active central nervous system (CNS) symptoms attributable to autoimmune disease within 12 months prior to trial intervention
- History of or current renal diseases (other than LN) that, in the opinion of the investigator, could interfere with assessment of LN or confound evaluation of disease activity
- Receipt of dialysis (hemodialysis or peritoneal dialysis) within 12 weeks of trial intervention
- Irreversible organ damage related to underlying disease (e.g., ESRD) where, in the opinion of the investigator, CD19 CAR T-cell therapy would be unlikely to benefit the participant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FT819Single Intravenous (IV) infusion of FT819 administered on Day 1 | Biological | FT819 |
Primary outcome
Complete Renal Response (CRR) at Week 26
Time frame: Week 26
Proportion of participants achieving CRR at Week 26, with CRR defined as the achievement of all of the following criteria: * UPCR <0.5 g/g * Estimated glomerular filtration rate (eGFR) ≥85% of baseline or ≥60 mL/min/1.73 m2 * No use of rescue therapy
8 secondary outcomes
CRR at Week 52
Time frame: Week 52
CRR at Week 104
Time frame: Week 104
Overall Renal Response
Time frame: Up to approximately 2 years
Proportion of participants who achieve PRR at Week 26, Week 52, and Week 104
Time frame: Up to approximately 2 years
Lupus Low Disease Activity State (LLDAS)
Time frame: Up to approximately 2 years
Definition of Remission in SLE (DORIS)
Time frame: Up to approximately 2 years
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Time frame: Up to approximately 2 years
Proportion of participants who achieve SLE Responder Index-4 (SRI-4)
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Corporate WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Lupus Nephritis
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
Lupus Nephritis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalie Shiff, MD contact
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FT819 in people with Lupus Nephritis and Systemic Lupus Erythematosus, run by Fate Therapeutics at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fate Clinical Trials (858-875-1800, clinicaltrials@fatetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Renal Response (CRR) at Week 26 (time frame: Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.