SLEEarly Phase 1NCT06548620
A Study of RD06-04 in Patients With Active Autoimmune Diseases
A Early Phase 1 study testing RD06-04 cell infusion in people with SLE and Sclerosis, run by Nanjing Bioheng Biotech Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, Phase I, investigator-initiated trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with autoimmune diseases mediated by autoantibodies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- SLE, Sclerosis, ANCA Associated Vasculitis
- What is being tested?
- RD06-04 cell infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2024to 31 Aug 2027
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects voluntarily participated in the study and signed the informed consent form.
- Age ≥18 years old and ≤70 years old, both sexes.
- Organ function and laboratory tests:
- Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (except Gilbert's syndrome).
- Renal function: creatinine ≤1.5×ULN or creatinine clearance ≥40 ml/min.
- Blood routine: neutrophil count ≥1×109/L, hemoglobin ≥60g/L, platelet count ≥20×109/L, lymphocyte count >0.3×109/L.
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- Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, or prothrombin time (PT) ≤ 1.5×ULN.
- Oxygen saturation (SpO2) ≥92% at rest in room air.
- Left ventricular ejection fraction (LVEF) ≥50% on echocardiography.
- Negative serum or urine pregnancy test results in female subjects of childbearing potential at screening.
- Women of childbearing potential must agree to use a highly effective method of contraception for at least 28 days before initiation of elution and up to 12 months after RD06-04 reinfusion. Men of childbearing potential had to agree to the use of an effective barrier method of contraception from the initiation of lymphoidectomy until 12 months after reinfusion of RD06-04 and had to refrain from donating semen or sperm throughout the trial.
- SLE Patient Inclusion Criteria:
- A definitive diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria.
- Positive antinuclear antibodies (ANA) at screening, and/or positive anti-double-stranded DNA (anti-dsDNA) antibodies, and/or positive anti-Smith antibodies.
- A SLEDAI-2K score >6 at screening, and a 'clinical' SLEDAI-2K score ≥4.
- SSc Patient Inclusion Criteria:
- Diagnosed with SSc according to the 2013 ACR/EULAR classification criteria.
- Diagnosed with diffuse cutaneous SSc at screening, with a disease duration ≤5 years.
- AAV Patient Inclusion Criteria:
- Meeting the diagnostic criteria for ANCA-associated vasculitis established by the 2022 ACR/EULAR, including Microscopic Polyangiitis (MPA), Granulomatosis with Polyangiitis (GPA), and Eosinophilic Granulomatosis with Polyangiitis (EGPA).
- Positive testing for ANCA-associated antibodies in the past or at screening (specifically, positive anti-myeloperoxidase antibodies, MPO-ANCA, or positive anti-proteinase 3 antibodies, PR3-ANCA).
- Diagnosed with IIM according to the 2017 ACR/EULAR classification criteria (including probable or definite diagnosis, i.e., probability ≥55%), including subtypes such as Dermatomyositis (DM), Anti-Synthetase Syndrome (ASS), and Immune-Mediated Necrotizing Myopathy (IMNM).
- Patients in the active phase, defined as those with at least 2 of the following six core set measures being abnormal: decreased muscle strength (MMT-8 <142), Physician Global Assessment (PhGA, 10cm VAS) ≥2cm, Patient Global Assessment (PtGA, 10cm VAS) ≥2cm, Extramuscular Disease Activity Total Score (assessed using the MDAAT scoring tool) ≥2cm, Health Assessment Questionnaire (HAQ) ≥0.25, and Creatine Kinase (CK) muscle enzyme levels ≥1.5×ULN
- Sjögren's Syndrome (SS) Patient Inclusion Criteria:
- Diagnosed with primary Sjögren's Syndrome according to the 2016 ACR/EULAR classification criteria.
- Positive for anti-SSA/Ro antibodies detected in the past or at screening.
- A score of ≥6 on the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) at screening.
- Multiple Sclerosis (MS) Patient Inclusion Criteria:
- Diagnosed with Relapsing-Remitting Multiple Sclerosis (RMS) according to the revised McDonald criteria of 2017, including Clinically Isolated Syndrome, Relapsing-Remitting MS (RRMS), and active Secondary Progressive MS.
- Expanded Disability Status Scale (EDSS) score is ≤5.
- NMOSD Patient Inclusion Criteria:
- Meeting the diagnostic criteria for NMOSD established by the International Panel for NMO Diagnosis (IPND) in 2015.
- Positive Aquaporin-4 Immunoglobulin G (AQP4-IgG) during the screening period or positive AQP4-IgG in previous medical records.
- Myasthenia Gravis (MG) Patient Inclusion Criteria:
- Patients diagnosed with generalized myasthenia gravis.
- Clinical classification of II, III, or IV by the Myasthenia Gravis Foundation of America (MGFA).
- Positive serological tests for acetylcholine receptor antibodies (AChR-Ab) or muscle-specific receptor tyrosine kinase antibodies (MuSK-Ab) or low-density lipoprotein receptor-related protein 4 antibodies (LRP4-Ab) at screening, or positive records of AChR-Ab, MuSK-Ab, or LRP4-Ab in previous medical history.
Who cannot join
- SLE Patients: Those with uncontrolled lupus crisis within the 8 weeks prior to screening, including rapidly progressive lupus nephritis, severe neuropsychiatric lupus, severe hemolytic anemia, severe immune thrombocytopenia, agranulocytosis, severe cardiac damage, severe lupus pneumonia, severe lupus hepatitis, and severe vasculitis, as assessed by the investigator as unsuitable to participate in this study.
- IIM Patients: Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.
- MG Patients: Presence of uncontrolled myasthenia gravis crisis within 2 weeks prior to screening.
- Patients with severe asthma or Chronic Obstructive Pulmonary Disease (COPD) are eligible. Patients with mild or moderate asthma or COPD who are receiving stable treatment can also be enrolled.
- There has been an active infection requiring systemic treatment within 2 weeks prior to the urethral irrigation, such as infectious pneumonia, tuberculosis, etc.
- Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis antibody.
- Pregnant or breastfeeding women.
- Any condition that, in the investigator's opinion, may affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 461499
About this study
Official title: Clinical Study on the Safety, Efficacy, and Pharmacokinetics of CD19-targeted CAR-T Cell Injection for the Treatment of Autoimmune Diseases Mediated by Autoantibodies.
This is an open-label, Phase I, investigator-initiated trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with autoimmune diseases mediated by autoantibodies. The study population includes patients with Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myopathy (IIM), Sjögren's Syndrome (SS), Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorder (NMOSD), and Myasthenia Gravis (MG).
- Being tested
- RD06-04 cell infusion
- Medical subject headings
- Sclerosis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD06-04 cell infusionDrug
CAR T Cells
| Study group | Role | What they receive |
|---|---|---|
| RD06-04 cell infusion | Experimental | Not described Receives: Drug: RD06-04 cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events, serious adverse events and incidence of adverse events of special inte rest
TEAEs.SAE.AESI
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start31 Aug 2024 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Why it stopped: R\&D strategy adjustment
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
- 0 participants (actual)
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
- NCT06548620
- Sponsor's protocol ID
- BHCT-RD06-04-04
- Status last verified
- Jan 2026
- First submitted
- 7 Aug 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety, Efficacy, and Pharmacokinetics of CD19-targeted CAR-T Cell Injection for the Treatment of Autoimmune Diseases Mediated by Autoantibodies.
- ClinicalTrials.gov ID
- NCT06548620
- Acronym / sponsor ID
- BHCT-RD06-04-04
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: R\&D strategy adjustment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nanjing Bioheng Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2024 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 12 Aug 2024 (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.
This is an open-label, Phase I, investigator-initiated trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with autoimmune diseases mediated by autoantibodies. The study population includes patients with Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myopathy (IIM), Sjögren's Syndrome (SS), Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorder (NMOSD), and Myasthenia Gravis (MG).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RD06-04 cell infusion | Experimental | Drug: RD06-04 cell infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- The subjects voluntarily participated in the study and signed the informed consent form.
- Age ≥18 years old and ≤70 years old, both sexes.
- Organ function and laboratory tests:
- Negative serum or urine pregnancy test results in female subjects of childbearing potential at screening.
- Women of childbearing potential must agree to use a highly effective method of contraception for at least 28 days before initiation of elution and up to 12 months after RD06-04 reinfusion. Men of childbearing potential had to agree to the use of an effective barrier method of contraception from the initiation of lymphoidectomy until 12 months after reinfusion of RD06-04 and had to refrain from donating semen or sperm throughout the trial.
Key exclusion criteria (8 listed)
- SLE Patients: Those with uncontrolled lupus crisis within the 8 weeks prior to screening, including rapidly progressive lupus nephritis, severe neuropsychiatric lupus, severe hemolytic anemia, severe immune thrombocytopenia, agranulocytosis, severe cardiac damage, severe lupus pneumonia, severe lupus hepatitis, and severe vasculitis, as assessed by the investigator as unsuitable to participate in this study.
- IIM Patients: Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.
- MG Patients: Presence of uncontrolled myasthenia gravis crisis within 2 weeks prior to screening.
- Patients with severe asthma or Chronic Obstructive Pulmonary Disease (COPD) are eligible. Patients with mild or moderate asthma or COPD who are receiving stable treatment can also be enrolled.
- There has been an active infection requiring systemic treatment within 2 weeks prior to the urethral irrigation, such as infectious pneumonia, tuberculosis, etc.
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 |
|---|---|---|
| RD06-04 cell infusionCAR T Cells | Drug | RD06-04 cell infusion |
Primary outcome
Incidence of treatment-emergent adverse events, serious adverse events and incidence of adverse events of special inte rest
Time frame: up to 2 years
TEAEs.SAE.AESI
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 RD06-04 cell infusion in people with SLE and Sclerosis, 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 37 inclusion and 8 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: withdrawn, as of the sponsor's last update on 3 Feb 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events, serious adverse events and incidence of adverse events of special inte rest (time frame: up to 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 Feb 2026.