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F01 in the Treatment of Moderate-to-severe Refractory Systemic Lupus Erythematosus

NCT06468683 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-06-21

No results posted yet for this study

Summary

This is a phase I clinical study to evaluate the safety , pharmacokinetic profile, and preliminary efficacy of F01 in patients with moderate-to-severe refractory systemic lupus erythematosus.

Conditions

  • Lupus Erythematosis

Interventions

BIOLOGICAL

After preconditioning with chemotherapy, F01 will be evaluated.

Biological: 0.5-3×10\^9 CAR+NK Cells, Treatment follows a lymphodepletion Drug: Fludarabine: 25-30 mg/m\^2 (D-5\~D-3) Drug: Cyclophosphamide: 250-300 mg/ m\^2 (D-5\~D-3)

Sponsors & Collaborators

  • Shanghai Simnova Biotechnology Co.,Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-06-15
Primary Completion
2027-01-31
Completion
2027-12-31

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 NCT06468683 on ClinicalTrials.gov