SLEEarly Phase 1NCT07203404
A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.
A Early Phase 1 study testing RD06-05 CART Cell Injection in people with SLE and LN, run by Nanjing Bioheng Biotech Co., Ltd. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SLE, LN, ANCA Associated Vasculitis
- What is being tested?
- RD06-05 CART Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2025to 23 Jul 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 36Show fewer
- 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.
- 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.
- 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.
- 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).
- Meeting the criteria for high-risk or relapsed/refractory membranous nephropathy:
- High-risk patients, defined as meeting any of the following criteria:
- 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;
- 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.
- Diagnosis of systemic sclerosis (SSc) according to the 2013 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria.
- 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).
- Definitive diagnosis of primary IgA nephropathy confirmed by renal biopsy pathology results obtained within 2 years prior to screening.
- At screening, 24-hour urinary protein ≥1 g/24 h, or urine protein-to-creatinine ratio (UPCR) ≥0.75 g/g.
- At screening, estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m².
- Standard therapy must have been completed for a minimum of 3 months before screening, with a stable drug dose maintained for at least 4 weeks; standard therapeutic agents include ACEIs, ARBs, and/or SGLT2 inhibitors.
- At screening, the subject's blood pressure shall be controlled at ≤150/90 mmHg.
Who cannot join
- 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.
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Qin Yi Shi, Doctor, +8613916517457, shi.yiqin@zs-hospital.sh.cn
About this study
Official title: A Clinical Study of the Safety, Efficacy, and Cell Pharmacokinetics of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.
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
- Being tested
- RD06-05 CART Cell Injection
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Anti-Glomerular Basement Membrane Disease, Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD06-05 CART Cell InjectionDrug
CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide
| Study group | Role | What they receive |
|---|---|---|
| RD06-05 | Experimental | Not described Receives: Drug: RD06-05 CART Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events (TEAEs), serious adverse events (SAEs), and adverse events of particular concern (AESI) during treatment
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start24 Jul 2025
- Primary completion23 Jul 2027 (estimated)
- Study completion23 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Bioheng Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203404
- Sponsor's protocol ID
- RD06-05
- Status last verified
- Jul 2026
- First submitted
- 23 Sep 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the Safety, Efficacy, and Cell Pharmacokinetics of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.
- ClinicalTrials.gov ID
- NCT07203404
- Acronym / sponsor ID
- RD06-05
- Conditions
- SLE, LN, ANCA Associated Vasculitis, ANCA-Associated Glomerulonephritis, Anti-GBM Disease, MN
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Nanjing Bioheng Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 23 Jul 2027 (estimated)
- Study completion
- 23 Jul 2028 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RD06-05 | Experimental | Drug: RD06-05 CART Cell Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- Willing and able to provide written informed consent.
- Aged ≥18 years and ≤75 years.
- Adequate organ function defined as:
- 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.
Key exclusion criteria (24 listed)
- Subjects with SLE/LN:
- Subjects with AAV/AAGN:
- Subjects with Anti-GBM Disease:
- Subjects with MN:
- Secondary membranous nephropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RD06-05 CART Cell InjectionCAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide | Drug | RD06-05 |
Primary outcome
The incidence of adverse events (TEAEs), serious adverse events (SAEs), and adverse events of particular concern (AESI) during treatment
Time frame: 2 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
Related trials for SLE
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Recruiting
Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous
Systemic Lupus Erthematosus (SLE)
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing RD06-05 CART Cell Injection in people with SLE and LN, run by Nanjing Bioheng Biotech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 36 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peng Yu (+86 18451117657, peng.yu@bioheng.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse events (TEAEs), serious adverse events (SAEs), and adverse events of particular concern (AESI) during treatment (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.