RecruitingNot ApplicableNCT06503224

An Exploratory Clinical Study of SCAR02 Targeting BCMA and CD19 for the Treatment of Refractory Autoimmune Diseases

An Exploratory Clinical Study of a Fourth-generation Autologous CAR-T Cell Injection (SCAR02) Targeting BCMA and CD19 for the Treatment of Refractory Autoimmune Diseases


Sponsor

The First Affiliated Hospital of University of Science and Technology of China

Enrollment

18 participants

Start Date

Apr 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open label, single-site, dose-escalation study in up to 18 participants with refractory autoimmune diseases. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a CAR-T cell therapy called SCAR02 (targeting both BCMA and CD19) in patients with severe, treatment-resistant autoimmune diseases including rheumatoid arthritis, lupus (SLE), Sjögren's syndrome (dry syndrome), and systemic sclerosis (scleroderma). **You may be eligible if...** - You are 18 or older with one of the autoimmune diseases listed (RA, SLE, Sjögren's, or systemic sclerosis) - Your disease remains active despite standard and advanced treatments - Your blood counts, liver, kidney, and clotting function meet minimum requirements - For RA: your disease activity is elevated and you have been on stable conventional DMARDs - For SLE: your disease is active with a SLEDAI score ≥ 8 despite standard treatment - For Sjögren's or systemic sclerosis: your disease is progressive despite conventional therapy **You may NOT be eligible if...** - You have serious brain or nervous system conditions (stroke, epilepsy, dementia, etc.) - You have significant heart disease (heart attack, heart failure, angina) - You have had an organ or bone marrow transplant - You have active or suspected serious infection (bacterial, viral, or fungal) - You have a history of cancer - You have active hepatitis B, hepatitis C, HIV, syphilis, CMV, or EBV infections - You are pregnant, breastfeeding, or planning pregnancy within 2 years Talk to your doctor to see if this trial is right for you.

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

DRUGAnti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis.

A single intravenous infusion of anti-BCMA and CD19 CART cells (dose-escalating infusion of 0.5-3 x10\^6 CART cells/kg).


Locations(1)

Hunan Siweikang Therapeutic Co.Ltd

Changsha, Hunan, China

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NCT06503224


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