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

NCT07203404 | Recruiting Early Phase 1

• 1 other identifier: RD06-05
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The incidence of adverse events (TEAEs), serious adverse events (SAEs), and adverse events of particular concern (AESI) during treatment

  2 Years

Study Arms (1)

RD06-05

EXPERIMENTAL

Drug: RD06-05 CART Cell Injection

Interventions

RD06-05 CART 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 - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.
• 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.

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.

Sponsors & Collaborators

• Nanjing Bioheng Biotech Co., Ltd.: lead

Study Sites (1)

Bioheng Study site

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Anti-Glomerular Basement Membrane Disease

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Peng Yu

CONTACT

+86 18451117657; peng.yu@bioheng.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: September 23, 2025
• First Posted: October 2, 2025
• Study Start: July 24, 2025
• Primary Completion (Estimated): July 23, 2027
• Study Completion (Estimated): July 23, 2028
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

CN (1)