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Phase I Clinical Study of GC012F Injection in Treatment of Refractory Systemic Lupus Erythematosus

NCT05846347 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-05-11

No results posted yet for this study

Summary

This is a phase I, single arm, non-randomized, open label, treatment study trial to determine the recommended phase II dose of GC012F injection (CD19-BCMA CAR-T cells) in patients with refractory systemic lupus erythematosus.

Conditions

  • CAR-T

Interventions

DRUG

GC012F injection

Each subject will receive GC012F injection (CD19-BCMA CAR-T cells) once by intravenous infusion on Day 0.

Sponsors & Collaborators

  • Gracell Biotechnologies (Shanghai) Co., Ltd.

    collaborator INDUSTRY

  • Zhejiang University

    lead OTHER

Principal Investigators

  • He Huang · Zhejiang University

  • Zhihong Liu · Zhejiang university school of medicine

  • Jin Lin · Zhejiang University

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
2023-05-15
Primary Completion
2023-10-19
Completion
2025-04-19

Countries

  • China

Study Locations

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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 NCT05846347 on ClinicalTrials.gov