A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis

Sponsor
Fate Therapeutics
Study ID
NCT07570862
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • FT819 — BIOLOGICAL
    Single Intravenous (IV) infusion of FT819 administered on Day 1

Study Details

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.

Key Dates

First listed
May 6, 2026
Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Jul 1, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
53 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FT819
    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

Primary Outcome Measure

Complete Renal Response (CRR) at Week 26 [ Time Frame: Week 26 ]

Central Contacts

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