Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429800
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-21
Brief Title:
A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants with Systemic Lupus Erythematosus
Sponsor:
Atara Biotherapeutics
Organization:
Atara Biotherapeutics
Study Overview
Official Title:
A Phase 1 Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 Allogeneic Anti-CD19 Chimeric Antigen Receptor T-cell CAR T Therapy in Subjects with Systemic Lupus Erythematosus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
The purpose of the study is to evaluate the safety and preliminary efficacy of ATA3219 for treatment of participants with lupus nephritis LN following lymphodepletion LD and in participants with extrarenal systemic lupus erythematosus SLE without LD
Detailed Description:
This is a Phase 1 multi-centered open-labeled dose escalation study to evaluate the safety and preliminary efficacy of ATA3219 as monotherapy in participants with LN following LD Cohort LN and in participants with extrarenal SLE ERL without LD Cohort ERL This study is planned to be conducted in the United States Canada and Australia For each cohort up to 3 dose levels DLs will be explored in the dose escalation portion of the study and if needed a lower dose may be explored Prior to undergoing any screening procedure prospective participants must undergo the ATA3219 inventory check assessments to ensure availability of an appropriate partially human leukocyte antigen HLA-matched ATA3219 product lot Before administration of ATA3219 participants will receive LD treatment Cohort LN or methylprednisolone treatment Cohort ERL For all enrolled participants hospitalization during and following ATA3219 dosing is mandatory Participants will receive a single dose intravenous IV infusion of ATA3219 monotherapy on Day 1 Participants will remain inpatient for a minimum of 1 week post ATA3219 dosing where they will be frequently monitored Clinical responses will be assessed by the investigator on Day 28 5 days following each dose of ATA3219 For each cohort during dose escalation up to 3 DLs of ATA3219 are planned to be evaluated sequentially and a lower dose may be added At least 3 and up to 6 dose-limiting toxicity DLT-evaluable participants those who complete the 28-day DLT observation period will be assessed at each DL Within each DL treatment will be staggered to allow appropriate safety monitoring by an independent Data Safety Monitoring Committee DSMC
Enrolled participants who do not receive ATA3219 for any cause eg rapid deterioration will be replaced Participants who experience an adverse event AE during the 28-day DLT observation and complete the observation period will not be replaced In addition if a participant is treated with ATA3219 and discontinues for any reason other than due to a DLT prior to completing the 28-day DLT observation period an additional participant may be enrolled at the dose level to ensure that the recommended phase 2 dose RP2D can be determined with a goal not to exceed 6 participants treateddose level In rare situations retreatment of participants with inadequate renal response may be considered
After treatment is completed or discontinued participants will be followed for safety and clinical response for up to 24 months from the last dose of ATA3219 A separate long-term follow-up study will be conducted to follow participants for up to a total of 15 years after their last dose of ATA3219
Enrolled participants who do not receive ATA3219 for any cause eg rapid deterioration will be replaced Participants who experience an adverse event AE during the 28-day DLT observation and complete the observation period will not be replaced In addition if a participant is treated with ATA3219 and discontinues for any reason other than due to a DLT prior to completing the 28-day DLT observation period an additional participant may be enrolled at the dose level to ensure that the recommended phase 2 dose RP2D can be determined with a goal not to exceed 6 participants treateddose level In rare situations retreatment of participants with inadequate renal response may be considered
After treatment is completed or discontinued participants will be followed for safety and clinical response for up to 24 months from the last dose of ATA3219 A separate long-term follow-up study will be conducted to follow participants for up to a total of 15 years after their last dose of ATA3219
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