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NOT YET RECRUITING
NCT07364396
PHASE1/PHASE2

Efficacy and Safety of CRC01 in Participants With Severe, Refractory Systemic Lupus Erythematosus

Sponsor: Curocell Inc.

View on ClinicalTrials.gov

Summary

The purpose of this clinical trial is to evaluate the safety and efficacy of CRC01, an investigational autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, in people with lupus nephritis (LN), a serious kidney complication of systemic lupus erythematosus (SLE). The main objectives of the study are: 1. To determine whether CRC01 infusion can improve kidney outcomes and reduce disease activity in participants with lupus nephritis. 2. To assess the safety profile, including potential risks such as cytokine release syndrome (CRS) and neurotoxicity. Study Design This is a single-arm, open-label, multi-center, Phase 1/2 study. All enrolled participants will receive CRC01 after screening and baseline assessments. Study Procedures Participants will: * Undergo eligibility screening, including blood tests, urine tests, and disease activity assessments. * Provide autologous T lymphocytes through a procedure called leukapheresis. * Receive a lymphodepleting pre-conditioning regimen (short course of chemotherapy). * Receive a single intravenous infusion of CRC01 cells. * Be hospitalized for close monitoring to detect and manage early adverse events such as CRS or neurotoxicity. * Return for scheduled follow-up assessments through Week 52 (12 months) post-infusion to evaluate safety and treatment response. Key Outcomes Researchers will measure: * Changes in proteinuria and kidney function. * Changes in disease activity scores. * Incidence and severity of adverse events.

Official title: An Open-label, Multi-center, Single-arm Phase 1/2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Participants With Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2026-02

Completion Date

2030-06

Last Updated

2026-01-23

Healthy Volunteers

No

Interventions

BIOLOGICAL

CRC01

Autologous T lymphocytes genetically modified to express anti-CD19 chimeric antigen receptor (CAR). Administered as a single intravenous infusion.