RecruitingEarly Phase 1NCT07203404

A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.

A Clinical Study of the Safety, Efficacy, and Cell Pharmacokinetics of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.

Sponsor

Nanjing Bioheng Biotech Co., Ltd.

Enrollment

96 participants

Start Date

Jul 24, 2025

Study Type

INTERVENTIONAL

Conditions

SLE IgA Nephropathy ANCA-associated Vasculitis IIM LN ANCA-Associated Glomerulonephritis Anti-GBM Disease MN SSc

Summary

An Exploratory, Single-Arm, Open-Label, Dose-Escalation Study of the Safety, Tolerability, PK, PD, and Efficacy of Anti-CD19/BCMA Universal CAR-T Therapy RD06-05 in Autoimmune Diseases (including SLE/LN, AAV/AAGN, Anti-GBM, MN, SSc, and IIM).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called RD06-05 CART Cell Injection for people with anca-associated glomerulonephritis, anca-associated vasculitis, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRD06-05 CART Cell Injection

CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide

Locations(1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT07203404

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