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A Study of CD19 Targeted CAR T Cell Therapy in Patients With Severe, Refractory Systemic Lupus Erythematosus (SLE) - Trial NCT06333483

Access comprehensive clinical trial information for NCT06333483 through Pure Global AI's free database. This Phase 1 trial is sponsored by Autolus Limited and is currently Recruiting. The study focuses on Systemic Lupus Erythematosus. Target enrollment is 12 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT06333483
Phase 1
Recruiting
biological
Trial Details
ClinicalTrials.gov โ€ข NCT06333483
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A Study of CD19 Targeted CAR T Cell Therapy in Patients With Severe, Refractory Systemic Lupus Erythematosus (SLE)
A Single-Arm, Open-Label, Phase I Study to Determine the Safety, Tolerability and Preliminary Efficacy of Obecabtagene Autoleucel in Patients With Severe, Refractory Systemic Lupus Erythematosus

Study Focus

Obecabtagene autoleucel (obe-cel)

Interventional

biological

Sponsor & Location

Autolus Limited

London, United Kingdom

Timeline & Enrollment

Phase 1

Feb 02, 2024

Oct 01, 2025

12 participants

Primary Outcome

Dose limiting toxicities,Adverse events

Summary

This is a Phase I study of obecabtagene autoleucel (obe-cel), autologous T cells engineered
 with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety,
 preliminary efficacy, and pharmacokinetics of obe-cel in patients with severe, refractory
 SLE.

ICD-10 Classifications

Systemic lupus erythematosus
Systemic lupus erythematosus, unspecified
Lupus erythematosus
Systemic lupus erythematosus with organ or system involvement
Other forms of systemic lupus erythematosus

Data Source

ClinicalTrials.gov

NCT06333483

Non-Device Trial