CD19/BCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases

NCT07596680 | Not Yet Recruiting Early Phase 1

• 1 other identifier: BHCT-RD06-05-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune diseases. The enrolled population consists of patients with active autoimmune diseases, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), ANCA-associated vasculitis (AAV), idiopathic inflammatory myopathies (IIM), Sjögren's syndrome (SS), among others. The CAR-T cell dose used in this study is 6×10⁶ CAR⁺ T cells/kg. Six subjects will be enrolled for each indication, with a total of 30 subjects to be enrolled.

Conditions

SLE - Systemic Lupus Erythematosus; Systemic Sclerosis; ANCA Associated Vasculitis; Idiopathic Inflammatory Myopathies; Sjögren Syndrome

Keywords

CD19/BCMA CAR-T

Outcome Measures

Primary Outcomes (15)

• SLE (systemic lupus erythematosus)

  Proportion of patients achieving lupus low disease activity state (LLDAS) and DORIS(Definition Of Remission In SLE) remission, as well as the proportion of patients achieving drug-free remission

  2 years

• SLE (systemic lupus erythematosus)

  Proportion of SLE patients with renal involvement who achieved complete renal response (CRR) and partial renal response

  2 years

• SLE (systemic lupus erythematosus)

  Change in UPCR(Urine Protein/Creatinine Ratio) from baseline in SLE patients with renal involvement

  2 years

• SLE (systemic lupus erythematosus)

  Change in eGFR(estimated Glomerular Filtration Rate) from baseline in SLE patients with renal involvement

  2 years

• SLE (systemic lupus erythematosus)

  Changes in SLEDAI-2K, Physician Global Assessment (PGA), and British Isles Lupus Assessment Group (BILAG) score from baseline

  2 years

• SLE (systemic lupus erythematosus)

  Changes in anti-dsDNA antibody, C3 and C4 levels from baseline

  2 years

• AAV (ANCA-associated vasculitis)

  Change in Birmingham Vasculitis Activity Score (BVAS) from baseline. The Birmingham Vasculitis Activity Score (BVAS) ranges from a minimum of 0 to a maximum of 63, with higher scores indicating worse disease activity and clinical outcomes.

  2 years

• AAV (ANCA-associated vasculitis)

  Proportion of patients with vasculitis relapse (including major flare and minor flare)

  2 years

• IIM (idiopathic inflammatory myopathies)

  Major clinical remission assessed according to the 2016 ACR/EULAR myopathy remission criteria

  2 years

• SSc (systemic sclerosis)

  Changes in modified Rodnan Skin Score (mRSS) from baseline

  2 years

• SSc (systemic sclerosis)

  Changes in European Scleroderma Trials and Research group (EUSTAR) Activity Index from baseline

  2 years

• SSc (systemic sclerosis)

  Changes in Forced Vital Capacity (FVC) and Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) from baseline in patients complicated with interstitial lung disease

  2 years

• SS (Sjögren's syndrome )

  Change in ESSDAI(EULAR Sjögren's Syndrome Disease Activity Index) score from baseline. ESSDAI has a score range from 0 to 105, with higher scores indicating greater disease activity and poorer clinical outcomes.

  2 years

• SS (Sjögren's syndrome )

  Change in ESPRI(EULAR Sjögren's Syndrome Patient Reported Index) score from baseline. ESSPRI ranges from a minimum of 0 to a maximum of 10, with higher scores indicating worse symptoms and poorer patient-reported outcomes.

  2 years

• SS (Sjögren's syndrome )

  Change in STAR(Sjögren's Tool for Assessing Response) score from baseline. STAR score ranges from 0 to 28, with higher scores indicating more severe disease status and poorer therapeutic response.

  2 years

Study Arms (1)

RD06-05

EXPERIMENTAL

Drug: RD06-05 CAR-T Cell Injection

Interventions

RD06-05 CAR-T Cell Injection DRUG

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

RD06-05

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily provides written informed consent.
• Age ≥18 and ≤70 years, any gender.
• Adequate organ function:
• ALT and AST ≤3×ULN; total bilirubin ≤2×ULN (excluding Gilbert syndrome).
• Creatinine ≤1.5×ULN or creatinine clearance ≥40 mL/min.
• Neutrophils ≥1×10⁹/L; hemoglobin ≥60 g/L; platelets ≥20×10⁹/L; lymphocytes \>0.3×10⁹/L.
• INR ≤1.5×ULN or PT ≤1.5×ULN.
• Resting room-air SpO₂ ≥92%.
• LVEF ≥50% on echocardiogram.
• Negative serum or urine pregnancy test for females of childbearing potential at screening.
• Highly effective contraception required from 28 days before lymphodepletion until 12 months after RD06-05 infusion for females; effective barrier contraception required from lymphodepletion until 12 months after RD06-05 infusion for males, with no sperm donation during the study.
• For SLE Patients
• Diagnosis of SLE per 2019 EULAR/ACR or 2012 SLICC criteria.
• Active disease despite ≥2 months of stable (≥2 weeks) treatment with glucocorticoids plus immunosuppressants and/or biologics; prednisone ≥7.5 mg/day or equivalent.
• Positive ANA, anti-dsDNA antibody, and/or anti-Smith antibody at screening.

You may not qualify if:

• Coexisting autoimmune disease confounding disease activity/safety (stable ≥3 months may be eligible with approval).
• Anti-CD20 mAb/T-cell engager within 3 months; CD19/BCMA-targeted therapy within 6 months (exception with CD19⁺ B-cell \> LLN and approval).
• Rapidly progressive glomerulonephritis (RPGN).
• NYHA III/IV heart failure; severe cardiac disease within 12 months.
• Severe CNS disease impairing compliance/assessments.
• Malignancy history (except cured non-melanoma skin cancer/carcinoma in situ, disease-free ≥3 years).
• Primary immunodeficiency.
• Uncontrolled infection (uncomplicated UTI/upper respiratory infection permitted).
• Positive HIV; positive HCV (except undetectable RNA); positive syphilis.
• Positive HBsAg; positive HBcAb (except undetectable HBV DNA).
• Positive EBV/CMV DNA/IgM at screening.
• Active/recurrent tuberculosis.
• Prior CAR-T or genetically modified immune cell therapy.
• Live attenuated vaccine within 4 weeks before enrollment.
• Hypersensitivity to cell therapy product components.

Sponsors & Collaborators

• Nanjing Bioheng Biotech Co., Ltd.: lead

Study Sites (2)

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215008, China

Location

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 220127, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Scleroderma, Systemic; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Myositis; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Qiong Fu, Doctor

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Gao, Master

CONTACT

+86 177 1418 8689; ming.gao@imvivabio.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: May 19, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)