Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-28 @ 6:59 PM
Study NCT ID:
NCT06340750
Status:
RECRUITING
Last Update Posted:
2025-06-03
First Post:
2024-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus
Sponsor:
Luminary Therapeutics
Organization:
Study Overview
Official Title:
A Phase I Study of BAFF CAR-T Cells (LMY-920) for Treatment of Systemic Lupus Erythematosus
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
This is an open label, phase 1 dose escalation study designed to establish the safety and RP2D of autologous BAFF CAR-T cells in adults with refractory SLE. The planned dose escalation includes 3 dose levels and one de-escalation level. The maximum tolerated dose (MTD) will be determined using a 3+3 dose escalation design. The MTD dose level cohort may be expanded to a total of 6 patients. RP2D may be selected at dose level(s) at or below the MTD based on all data then available (e.g. efficacy, safety, PK and PD), and additional patients enrolled at these levels to expand up to a total of 40 patients in the study, in order to further evaluate safety and efficacy and guide Phase 2 trial design.
To ensure patient safety, during dose escalation, treatment of subjects at each dose will be staggered by at least 14 days. For example, the second subject will be enrolled only after the first subject has finished 14 days of safety monitoring from the CAR-T cell infusion, and the third subject will be enrolled only after the second subject has finished 14 days of safety monitoring from the CAR-T cell infusion. In the expansion cohorts, this staggering interval will no longer be required.
To ensure patient safety, during dose escalation, treatment of subjects at each dose will be staggered by at least 14 days. For example, the second subject will be enrolled only after the first subject has finished 14 days of safety monitoring from the CAR-T cell infusion, and the third subject will be enrolled only after the second subject has finished 14 days of safety monitoring from the CAR-T cell infusion. In the expansion cohorts, this staggering interval will no longer be required.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: