BAFF CAR-T Cells for Lupus

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Luminary Therapeutics

No Placebo Group

Trial Summary

What is the purpose of this trial?This phase 1 study seeks to examine the safety and recommended phase 2 dose (RP2D) of BAFF-ligand CAR-T cells (LMY-920) in adult patients with refractory systemic lupus erythematosus (SLE). It is hypothesized that BAFF CAR-T cells will be safe and will improve SLE disease activity scores.

Eligibility Criteria

This trial is for adults aged 18-69 with active systemic lupus erythematosus (SLE) who haven't responded to standard treatments like corticosteroids and hydroxychloroquine, or other drugs such as methotrexate. Participants must have a creatinine clearance of at least 30 ml/min, stable heart function with an ejection fraction ≥40%, good lung function (pulse oximetry ≥92% on room air), and liver enzymes within acceptable limits.

Inclusion Criteria

I am between 18 and 69 years old.

My condition did not improve after standard and additional treatments.

I rely on steroids for my condition.

+6 more

Participant Groups

The study is testing the safety and optimal dose for phase 2 of LMY-920, which are CAR-T cells targeting BAFF-ligand in patients with refractory SLE. The goal is to see if these modified immune cells can safely improve disease activity scores in SLE patients.

1Treatment groups

Experimental Treatment

Group I: BAFF CAR TExperimental Treatment1 Intervention

Autologous BAFF CAR T Therapy