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Clinical Study of ZM001 Injection in the Treatment of Refractory Systemic Lupus Erythematosus

NCT06852573 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-02-28

No results posted yet for this study

Summary

This is an open, single-arm, phase I clinical study of ZM001 in patients with refractory systemic lupus erythematosus

Conditions

Interventions

BIOLOGICAL

ZM001 Injection

ZM001 injection, 2.5× 10\^7 CAR-T cells, 5× 10\^7 CAR-T cells, 1× 10\^8 CAR-T cells and 2× 10\^8 CAR-T cells, treatment follows a lymphodepletion. Drug: Fludarabine Recommendation: 30 mg/m\^2 (D-5\~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 300 mg/ m\^2 (D-5\~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 300 mg/ m\^2 (D-5\~D-3), determined by tumor burden at baseline.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Beijing Immunochina Medical Science & Technology 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
2025-02-20
Primary Completion
2026-02-20
Completion
2027-08-20

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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 NCT06852573 on ClinicalTrials.gov