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A Study of RJMty19 in Refractory Systemic Lupus Erythematosus (SLE)

NCT06340490 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-04-01

No results posted yet for this study

Summary

This study is an open-label, single-arm, dose escalation and dose expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic characteristics of allogeneic CD19-CAR-DNT cells (RJMty19) after infusion, and preliminary efficacy in systemic lupus erythematosus (SLE) subjects.

Conditions

Interventions

BIOLOGICAL

RJMty19 (CD19-CAR-DNT cells)

Lentiviral vector-transducted double negative T cells (DNT) to express anti-CD19 CAR. Prior to cellular infusion, each patient received cyclophosphamide and fludarabine lymphodepleting chemotherapy.

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER

  • Peking University People's Hospital

    collaborator OTHER

  • Changhai Hospital

    collaborator OTHER

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    collaborator OTHER

  • Guangdong Ruishun Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Shuang Ye, MD, PhD · RenJi Hospital

  • Zhanguo Li, MD, PhD · Peking University People's Hospital

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
2024-05-15
Primary Completion
2026-12-31
Completion
2027-12-31

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 NCT06340490 on ClinicalTrials.gov