MedTrace Logo

An Open-label Study of GC012F in Rheumatoid Arthritis.

NCT07315503 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-01-02

No results posted yet for this study

Summary

This is An Open-label Study to Evaluate the Safety and Efficacy of GC012F in Patients with Difficult-to-Treat (D2T) Rheumatoid Arthritis.

Conditions

Interventions

DRUG

LD and GC012F CAR-T Cell Injection

Subjects will receive cyclophosphamide 200 to 300 mg/m2 and fludarabine 20 to 30 mg/m2 once daily for 3 days either on Days -5, -4 and -3 or on Days -4, -3 and -2 prior to CAR-T cell infusion.

DRUG

GC012F CAR-T Cell Injection

the LD-free cohort ，directly receiving GC012F infusion without lymphodepletion.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • Ying Wang · Institute of Hematology & Blood Diseases Hospital, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2028-01-15
Completion
2041-01-15

Countries

  • China

Study Locations

More Related Trials

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 NCT07315503 on ClinicalTrials.gov