A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Lupus Nephritis

Systemic Lupus Erythematosus Clinical Trial

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 Lupus Nephritis

Status Not yet recruiting

Clinical Trial Summary

The purpose of the study is to evaluate the safety and preliminary efficacy of ATA3219 (following lymphodepletion) for treatment of participants with lupus nephritis (LN).

Clinical Trial 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. 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 lot. Before administration of ATA3219, participants will receive conditioning chemotherapy. 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. Lupus nephritis activity will be assessed by the investigator on Day 28 (+ 5 days) following each dose of ATA3219. During dose escalation, up to 3 dose levels 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 dose level. Within each dose level, treatment will be staggered to allow appropriate safety monitoring by an independent Data Safety Monitoring Committee (DSMC).

Participants who do not receive ATA3219 for any cause may be replaced. Participants who experience an adverse event (AE) prior to completion of the 28-day DLT observation period will not be replaced. If a participant is treated with ATA3219 and discontinues for any reason other than 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. 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 renal 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. ;

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Lupus Nephritis
• Nephritis
• Systemic Lupus Erythematosus

• NCT number: NCT06429800
• Study type: Interventional
• Source: Atara Biotherapeutics
• Contact: Study Director
• Phone: 650-278-8930
• Email: clinicalstudies@atarabio.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 31, 2024
• Completion date: April 2029