Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340750
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-03-12
Brief Title:
BAFF CAR-T Cells LMY-920 for Systemic Lupus Erythematosus
Sponsor:
Luminary Therapeutics
Organization:
Luminary Therapeutics
Study Overview
Official Title:
A Phase I Study of BAFF CAR-T Cells LMY-920 for Treatment of Systemic Lupus Erythematosus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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 33 dose escalation design The MTD dose level cohort may be expanded to a total of 6 patients RP2D may be selected at dose levels at or below the MTD based on all data then available eg 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:
None
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?:
None
Is an FDA AA801 Violation?:
None