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

Recruiting now · Early Phase 1

Conditions studied: SLE, LN, ANCA Associated Vasculitis, ANCA-Associated Glomerulonephritis, Anti-GBM Disease, MN, SSc, IIM, IgA Nephropathy

In brief

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).

Key facts

Study ID: NCT07203404
Run by: Nanjing Bioheng Biotech Co., Ltd.
People needed: 96
Starts: 2025-07-24
Expected to finish: 2028-07-23
Last updated by the study team: 2026-08-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Willing and able to provide written informed consent.
Aged ≥18 years and ≤75 years.
Adequate organ function defined as:
Bone marrow function: Defined as absolute neutrophil count (ANC) ≥1500/μL, absolute lymphocyte count (ALC) ≥100/μL, hemoglobin (Hb) ≥80 g/L, and platelet count (PLT) ≥50,000/μL. Transfusions and growth factors must not have been used within 7 days prior to screening to meet these criteria.
Liver function: Defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN), and total bilirubin <1.5 × ULN (or <3.0 × ULN for subjects with Gilbert's syndrome).
Coagulation function: Defined as international normalized ratio (INR) or partial thromboplastin time (PTT) ≤1.5 × ULN.
Pulmonary function: Defined as dyspnea ≤ Grade 1 per CTCAE and oxygen saturation (SpO₂) ≥92% on room air (by pulse oximetry).
Female subjects of childbearing potential must have a negative serum or urine pregnancy test. Females who are surgically sterile or postmenopausal for at least 2 years are considered not of childbearing potential.
From the time of signing the informed consent form until 6 months after the completion of RD06-05 infusion, female subjects of childbearing potential and male subjects with partners of childbearing potential must use highly effective methods of contraception.
Inclusion Criteria for Subjects with Anti-GBM Disease:
Diagnosis of anti-GBM disease according to the 2012 Chapel Hill Consensus Conference definitions, meeting both of the following criteria:
Positive for anti-GBM antibody (based on historical or screening test results);
Evidence of renal involvement at screening, defined as:
Presence of active, pathologically confirmed anti-GBM disease (renal biopsy must have been performed within 1 year prior to the screening visit or during the screening period); and
Accompanied by proteinuria and hematuria.
Inclusion Criteria for Subjects with SLE/LN:
Diagnosis of SLE according to the 2019 European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria.
Positive for antinuclear antibody (ANA), and/or anti-double-stranded DNA (anti-dsDNA) antibody, and/or anti-Smith (anti-Sm) antibody at screening.
SLEDAI-2K score > 6 points at screening.
Inclusion Criteria for Subjects with AAV/AAGN:
Diagnosis of microscopic polyangiitis (MPA) or granulomatosis with polyangiitis (GPA) according to the 2022 ACR/EULAR classification criteria for ANCA-associated vasculitis.
Positive for anti-myeloperoxidase (MPO-ANCA) antibody or anti-proteinase 3 (PR3-ANCA) antibody at screening or based on historical testing.
For AAV without renal involvement: A Birmingham Vasculitis Activity Score (BVAS) version 3 score of ≥3 at screening, indicating active vasculitis.
Inclusion Criteria for Subjects with MN:
Diagnosis of primary (idiopathic) membranous nephropathy confirmed by renal biopsy pathology (the renal biopsy must have been performed within 2 years prior to screening or during the screening period).

You may not qualify if…

Subjects with SLE/LN:
Severe active central nervous system (CNS) lupus, including psychosis, seizures, lupus headache, or other signs/symptoms associated with neuropsychiatric lupus, as assessed by a qualified specialist during screening.
Drug-induced or secondary lupus.
Subjects with AAV/AAGN:
Drug-induced or secondary AAV/AAGN.
Presence of alveolar hemorrhage requiring invasive ventilatory support at screening.
Subjects with Anti-GBM Disease:
Anuria for more than 7 days.
Dialysis dependence for more than 30 days.
Ongoing moderate or severe pulmonary hemorrhage (or cessation within the past two weeks) defined as pulmonary hemorrhage requiring assisted ventilation, supplemental oxygen, or blood transfusion.
Symptomatic congestive heart failure (NYHA Class 2-4) requiring prescription medication or clinically significant cardiogenic peripheral edema.
Subjects with MN:
Secondary membranous nephropathy.
Subjects with IIM:
Presence of severe rhabdomyolysis or CK level ≥120 × ULN at screening.
Subjects with SSc:
History of scleroderma renal crisis within 1 year prior to screening.
History of cardiac tamponade within 6 months prior to screening.
Active infection of digital ulcers within 3 months prior to screening.
Presence of digital gangrene at screening.
Subjects with IgAN:
Patients with secondary IgA nephropathy induced by Henoch-Schönlein purpura, systemic lupus erythematosus, hepatitis, infection, or other conditions.
Subjects concurrently diagnosed with other etiologies of chronic kidney disease, including but not limited to diabetic nephropathy or other primary glomerulopathies, if the Investigator judges such conditions may increase risks or confound efficacy assessment, will be excluded.
Renal biopsy pathology showing renal tubular atrophy or interstitial fibrosis ≥75%; or global glomerulosclerosis involving ≥75% of glomeruli.

Where it is running

Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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