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A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus

NCT06373991 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-06-17

No results posted yet for this study

Summary

The goal of this clinical trial is to test ATHENA CAR-T injection in adults with moderate to severe Systemic Lupus Erythematosus. The main question it aims to answer is:

• To evaluate the safety and tolerability of ATHENA CAR-T.

After screening, participants will be subjected to lymphodepletion regimen. After recovery, participants will be injected with ATHENA CAR-T injection and followed up to 24 months.

Conditions

  • Lupus Erythematosus, Systemic

Interventions

BIOLOGICAL

ATHENA CAR-T

Phase 1 dose escalation (3+3): dose 1 and dose 2.

DRUG

Fludarabine

Intravenous injection of fludarabine.

DRUG

Cyclophosphamide

Intravenous injection of cyclophosphamide.

Sponsors & Collaborators

  • The First Affiliated Hospital of Henan University of Science and Technology

    collaborator OTHER

  • Changping Laboratory

    collaborator OTHER

  • EdiGene Inc.

    lead INDUSTRY

Principal Investigators

  • Xiaofei Shi, MD · The First Affiliated Hospital of Henan University of Science and Technology

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
2024-07-24
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06373991 on ClinicalTrials.gov