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CNCT19 Cell Injection for Refractory Systemic Lupus Erythematosus

NCT05930314 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-07-05

No results posted yet for this study

Summary

Investigator-initiated, single-arm, open-label, single dose clinical study to evaluate the safety and preliminary efficacy of CNCT19 in treatment of patients with refractory systemic lupus erythematosus(SLE) presented with active lupus nephritis or active immune thrombocytopenia.

Conditions

Interventions

DRUG

CNCT19 cell injection

Leukapheresis and manufacturing of CNCT19: enrolled subjects will undergo a leukapheresis to target a yield of \> 1x 10\^9 mononuclear cells * Lymphodepleting chemotherapy i. Fludarabine 25 to 30 mg/m2, once daily for 3 days ii. Cyclophosphamide 500 mg/m2, once daily for 3 days * CNCT19 administration i. 0.25 to 0.5 x 10\^8 CAR-positive viable T cells

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Xiaofeng Zeng, Dr · Peking Union Medical College Hospital

  • Daobin Zhou, Dr · Peking Union Medical College Hospital

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
2023-06-19
Primary Completion
2024-05-30
Completion
2025-05-30

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 NCT05930314 on ClinicalTrials.gov