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

NCT07364396 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

CRC01

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

Sponsors & Collaborators

  • Curocell Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2030-06-30
Completion
2030-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07364396 on ClinicalTrials.gov