FT819 for Lupus

Recruiting at 13 trial locations

Overseen By Fate Clinical Trials

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Fate Therapeutics

Must not be taking: CNS medications

Disqualifiers: Neurological symptoms, Irreversible organ damage, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

244 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called FT819 to determine its safety and effectiveness for people with certain autoimmune diseases, such as lupus, vasculitis, myositis, and systemic sclerosis. The researchers aim to understand how this treatment affects immune cells and whether it reduces symptoms. Participants will receive varying doses, with or without an additional drug, to identify the best approach. The trial seeks individuals who have struggled with these autoimmune diseases and have not found success with at least two other treatments. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects on the human body.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, it mentions that participants must have failed to respond to certain treatments, which suggests you might need to continue some existing medications. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that FT819 demonstrates promising safety results in studies with patients who have conditions like lupus. Among 8 patients treated with FT819, no serious side effects were directly linked to the treatment. Specifically, there were no cases of cytokine release syndrome (a serious immune reaction) or nerve damage, suggesting that the treatment is generally well-tolerated.

These findings are important because the trial is in an early phase, primarily focused on assessing safety. The absence of severe side effects in these initial studies is a positive sign for those considering participation in the clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for lupus, which typically include corticosteroids and immunosuppressants, FT819 is a unique cell therapy that uses engineered T-cells to target the disease. Researchers are excited about FT819 because it has the potential to offer a more precise approach by directly modifying immune cells to combat lupus, potentially reducing the need for broad immunosuppression. Additionally, various regimens are being explored, such as single and two-dose options, with and without AMP, offering flexibility and possibly minimizing side effects. This innovative approach could revolutionize lupus treatment by offering tailored therapeutic options with fewer side effects compared to conventional therapies.

What evidence suggests that this trial's treatments could be effective for conditions like SLE, AAV, IIM, and SSc?

Research has shown that FT819 holds promise for treating autoimmune conditions like lupus. In earlier studies, all three patients with severe lupus nephritis (a kidney problem caused by lupus) responded well to FT819, showing significant improvement in kidney function. Another patient with lupus affecting other parts of the body maintained low disease activity for over three months. FT819 targets certain cells called CD19+ B cells, which play a major role in lupus and similar diseases. These early findings suggest FT819 could be effective for people with lupus and other autoimmune conditions. Participants in this trial will receive different regimens of FT819, including single-dose and two-dose options, with or without AMP and background therapy. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

Adults aged 18-40 with moderate to severe active systemic lupus erythematosus (SLE) who haven't responded to standard treatments, including glucocorticoids and other specific medications. Participants must meet certain SLE diagnostic criteria and have active disease as indicated by clinical scores.

Inclusion Criteria

My blood test shows positive for specific autoimmune antibodies.

My condition did not improve after using steroids and at least two other specific treatments for 3 months.

I have been diagnosed with lupus according to EULAR/ACR criteria.

Exclusion Criteria

My lupus has caused severe organ damage that likely won't improve with CD19 CAR T-cell therapy.

I am experiencing neurological symptoms due to lupus.

I have had CAR T-cell therapy, an organ transplant, or a stem cell transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation

Participants receive escalating doses of FT819 to evaluate safety and determine the recommended Phase 2 dose

4 weeks

Expansion

Further evaluation of the safety and activity of FT819 in a larger group of participants

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FT819

Trial Overview The trial is testing FT819, a new therapy, after conditioning chemotherapy in people with SLE. It includes a dose-escalation stage to find the safe amount of FT819 followed by an expansion stage to further assess its safety and effectiveness against B-cells.

How Is the Trial Designed?

Group I: Regimen D (Two-dose without AMP, with background therapy) Experimental Treatment 1 Intervention

Group II: Regimen C (Two-dose with AMP) Experimental Treatment 4 Interventions

Group III: Regimen B1 (Single-dose without AMP, background therapy temporarily suspended) Experimental Treatment 1 Intervention

Group IV: Regimen B (Single-dose without AMP, with background therapy) Experimental Treatment 1 Intervention

Group V: Regimen A (Single dose with AMP) Experimental Treatment 4 Interventions

Who Is Running the Clinical Trial?

Fate Therapeutics

Lead Sponsor

Trials

22

Recruited

1,200+

Citations

1. ir.fatetherapeutics.com ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-presents-new-clinical-data-acr-convergence

Fate Therapeutics Presents New Clinical Data at ACR ... As of the data cut-off date, the patient with extrarenal lupus had surpassed the 3-month evaluation timepoint and achieved low lupus disease ...

2. ir.fatetherapeutics.com ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-announces-updated-clinical-data-ft819-shelf

Fate Therapeutics Announces Updated Clinical Data for ... All three patients treated with FT819 following fludarabine-free conditioning regimen for severe lupus nephritis achieve Primary Efficacy Renal Response (PERR).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06308978

NCT06308978 | A Phase 1 Study of FT819 in B-cell ... This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496725010891

OP0032 Treatment of Refractory Systemic Lupus ... These findings support the continued evaluation of FT819 in SLE and expansion to other B-cell mediated autoimmune diseases, including ANCA-associated vasculitis ...

5. lupus.org lupus.org/news/fate-therapeutics-announces-promising-initial-data-from-ft819-phase-1-study-for-moderate-to

Fate Therapeutics Announces Promising Initial Data from ... The ongoing trial is evaluating safety, pharmacokinetics, and efficacy of FT819 in targeting CD19+ B cell activity. FT819 is an off-the-shelf, ...

6. ir.fatetherapeutics.com ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-presents-new-phase-1-clinical-data-ft819-shelf

Fate Therapeutics Presents New Phase 1 Clinical Data of ... Fate Therapeutics Presents New Phase 1 Clinical Data of FT819 Off-the-shelf, CAR T-cell Product Candidate for Systemic Lupus Erythematosus.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06308978

NCT06308978 | A Phase 1 Study of FT819 in B-cell ... This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary ...