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A Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus

NCT06530849 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2026-05-15

No results posted yet for this study

Summary

This is a single-arm, open-label, multicenter, phase 1/2 clinical study to assess the safety and efficacy of GC012F Injection in subjects with refractory Systemic Lupus Erythematosus (SLE).

Conditions

  • Refractory Systemic Lupus Erythematosus

Interventions

DRUG

GC012F Injection

GC012F Injection is an autologous chimeric antigen receptor T cell therapy targeting both BCMA and CD19

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Suzhou Gracell Biotechnologies Co., Ltd.

    collaborator UNKNOWN

  • Gracell Biotechnologies (Shanghai) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-22
Primary Completion
2027-02-01
Completion
2027-02-01

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

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 NCT06530849 on ClinicalTrials.gov