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

NCT ID: NCT07203404

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-24
• Study Completion Date: 2028-07-23

Brief 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).

Conditions

SLE; LN; ANCA Associated Vasculitis; ANCA-Associated Glomerulonephritis; Anti-GBM Disease; MN; SSc; IIM

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RD06-05

Group Type: EXPERIMENTAL

RD06-05 CART Cell Injection

Intervention Type: DRUG

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

Interventions

RD06-05 CART Cell Injection

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Willing and able to provide written informed consent.

2. Aged ≥18 years and ≤75 years.

3. Adequate organ function defined as:

1. 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.

2. 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).

3. Coagulation function: Defined as international normalized ratio (INR) or partial thromboplastin time (PTT) ≤1.5 × ULN.

4. Pulmonary function: Defined as dyspnea ≤ Grade 1 per CTCAE and oxygen saturation (SpO₂) ≥92% on room air (by pulse oximetry).

4. 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.

5. 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.

Diagnosis of anti-GBM disease according to the 2012 Chapel Hill Consensus Conference definitions, meeting both of the following criteria:

1. Positive for anti-GBM antibody (based on historical or screening test results);

2. Evidence of renal involvement at screening, defined as:

1. 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

2. Accompanied by proteinuria and hematuria.

1. 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.

2. Positive for antinuclear antibody (ANA), and/or anti-double-stranded DNA (anti-dsDNA) antibody, and/or anti-Smith (anti-Sm) antibody at screening.

3. SLEDAI-2K score > 6 points at screening.

1. Diagnosis of microscopic polyangiitis (MPA) or granulomatosis with polyangiitis (GPA) according to the 2022 ACR/EULAR classification criteria for ANCA-associated vasculitis.

2. Positive for anti-myeloperoxidase (MPO-ANCA) antibody or anti-proteinase 3 (PR3-ANCA) antibody at screening or based on historical testing.

3. For AAV without renal involvement: A Birmingham Vasculitis Activity Score (BVAS) version 3 score of ≥3 at screening, indicating active vasculitis.

1. 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).

2. Meeting the criteria for high-risk or relapsed/refractory membranous nephropathy:

High-risk patients, defined as meeting any of the following criteria:

1. Normal eGFR with urine protein >3.5g/24h, a reduction of <50% in urine protein after 6 months of ACEI/ARB treatment, and serum albumin <25 g/L or anti-PLA2R antibody >50 RU/mL;

2. eGFR <60 mL/min/1.73m² and/or urine protein >8g/24h for more than 6 months.

Refractory/Relapsed patients:

Refractory patients are defined as those resistant to prior immunosuppressive therapy (persistent urine protein ≥3.5g/24h with a <50% reduction from baseline).

Relapsed patients are defined as those who achieved complete or partial remission with prior immunosuppressive therapy but subsequently developed recurrent urine protein ≥3.5g/24h.

1. Diagnosis of systemic sclerosis (SSc) according to the 2013 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria.

2. Diagnosis of diffuse cutaneous SSc at screening.

1.Diagnosis of idiopathic inflammatory myopathy (IIM) according to the 2017 ACR/EULAR classification criteria (including probable or definite diagnosis, corresponding to a probability score of ≥55%). The subtypes include dermatomyositis (DM), anti-synthetase syndrome (ASS), and immune-mediated necrotizing myopathy (IMNM).

Exclusion Criteria

1. Subjects with SLE/LN:

1. 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.

2. Drug-induced or secondary lupus.

2. Subjects with AAV/AAGN:

1. Drug-induced or secondary AAV/AAGN.

2. Presence of alveolar hemorrhage requiring invasive ventilatory support at screening.

3. Subjects with Anti-GBM Disease:

1. Anuria for more than 7 days.

2. Dialysis dependence for more than 30 days.

3. 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.

4. Symptomatic congestive heart failure (NYHA Class 2-4) requiring prescription medication or clinically significant cardiogenic peripheral edema.

4. Subjects with MN:

Secondary membranous nephropathy.

5. Subjects with IIM:

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

6. Subjects with SSc:

1. History of scleroderma renal crisis within 1 year prior to screening.

2. History of cardiac tamponade within 6 months prior to screening.

3. Active infection of digital ulcers within 3 months prior to screening.

4. Presence of digital gangrene at screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Bioheng Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bioheng Study site

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Peng Yu

Role: CONTACT

peng.yu@bioheng.com

+86 18451117657

Facility Contacts

Peng Yu

Role: primary

peng.yu@bioheng.com

+8618451117657

Other Identifiers

RD06-05

Identifier Type: -

Identifier Source: org_study_id