Recruiting

CD19/BCMA CAR-T Therapy for Autoimmune Diseases

What is being tested

RD06-05 CART Cell Injection

Drug

Who is being recruted

Autoimmune Diseases+9

+ Cardiovascular Diseases

+ Connective Tissue Diseases

From 18 to 70 Years

+21 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Early Phase 1

Interventional

Study Start: January 2025

See protocol details

Summary

Principal SponsorNanjing Bioheng Biotech Co., Ltd.

Study ContactXiao Shi

Last updated: February 3, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 3, 2025

Actual date on which the first participant was enrolled.

This study is focused on testing a new treatment called RD06-05 for people with certain autoimmune diseases, such as active Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), Anti-Neutrophil Cytoplasmic Antibody-associated Vasculitis (AAV), Idiopathic Inflammatory Myopathies (IIM), Neuromyelitis Optica Spectrum Disorder (NMOSD), Multiple Sclerosis (MS), and Myasthenia Gravis (MG). These diseases involve the immune system mistakenly attacking the body's own tissues. By exploring the effects of RD06-05, the study aims to discover if this treatment is safe and how it behaves in the body. Success in this study could lead to improved treatments for these challenging conditions, potentially bringing relief to many patients. Participants in this study receive RD06-05, and the research team closely monitors their health to assess the treatment's safety and how well their bodies tolerate it. They measure how the drug is processed by the body (pharmacokinetics) and how it affects the body (pharmacodynamics). This involves regular check-ups and tests to ensure any side effects are identified early on. While the study does not yet have specific primary outcomes listed, it will focus on understanding these key areas to gather comprehensive data on RD06-05's potential benefits and risks.

Official TitleClinical Study on Targeted CD19/BCMA CAR-T Therapy for Autoimmune Diseases

NCT06775912

Principal SponsorNanjing Bioheng Biotech Co., Ltd.

Study ContactXiao Shi

Last updated: February 3, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesCardiovascular DiseasesConnective Tissue DiseasesImmune System DiseasesScleroderma, SystemicSkin DiseasesVascular DiseasesVasculitisSkin and Connective Tissue DiseasesSkin Diseases, VascularSystemic VasculitisAnti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Criteria

17 inclusion criteria required to participate

A definitive diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria.

Positive antinuclear antibodies (ANA) at screening, and/or positive anti-double-stranded DNA (anti-dsDNA) antibodies, and/or positive anti-Smith antibodies.

A SLEDAI-2K score >6 at screening, and a 'clinical' SLEDAI-2K score ≥4.

Patients in the active phase, defined as those with at least 2 of the following six core set measures being abnormal: decreased muscle strength (MMT-8 <142), Physician Global Assessment (PhGA, 10cm VAS) ≥2cm, Patient Global Assessment (PtGA, 10cm VAS) ≥2cm, Extramuscular Disease Activity Total Score (assessed using the MDAAT scoring tool) ≥2cm, Health Assessment Questionnaire (HAQ) ≥0.25, and Creatine Kinase (CK) muscle enzyme levels ≥1.5×ULN

Show More Criteria

4 exclusion criteria prevent from participating

Any condition that, in the investigator's opinion, may affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.

Those with uncontrolled lupus crisis within the 8 weeks prior to screening, including rapidly progressive lupus nephritis, severe neuropsychiatric lupus, severe hemolytic anemia, severe immune thrombocytopenia, agranulocytosis, severe cardiac damage, severe lupus pneumonia, severe lupus hepatitis, and severe vasculitis, as assessed by the investigator as unsuitable to participate in this study.

Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.

Pregnant or breastfeeding women.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

The First People's Hospital of Lianyungang

Lianyungang, ChinaOpen The First People's Hospital of Lianyungang in Google Maps

Recruiting

One Study Center