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SLE - Systemic Lupus ErythematosusEarly Phase 1NCT07596680

CD19/BCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases

A Early Phase 1 study testing RD06-05 CAR-T Cell Injection in people with SLE - Systemic Lupus Erythematosus and Systemic Sclerosis, run by Nanjing Bioheng Biotech Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune diseases. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
RD06-05 CAR-T Cell Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Sep 2026to 30 Apr 2029
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General Inclusion Criteria (All Patients)
  • Voluntarily provides written informed consent.
  • Age ≥18 and ≤70 years, any gender.
  • Adequate organ function:
  • ALT and AST ≤3×ULN; total bilirubin ≤2×ULN (excluding Gilbert syndrome).
  • Creatinine ≤1.5×ULN or creatinine clearance ≥40 mL/min.
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  • Neutrophils ≥1×10⁹/L; hemoglobin ≥60 g/L; platelets ≥20×10⁹/L; lymphocytes >0.3×10⁹/L.
  • INR ≤1.5×ULN or PT ≤1.5×ULN.
  • Resting room-air SpO₂ ≥92%.
  • LVEF ≥50% on echocardiogram.
  • Negative serum or urine pregnancy test for females of childbearing potential at screening.
  • Highly effective contraception required from 28 days before lymphodepletion until 12 months after RD06-05 infusion for females; effective barrier contraception required from lymphodepletion until 12 months after RD06-05 infusion for males, with no sperm donation during the study.
  • For SLE Patients
  • Diagnosis of SLE per 2019 EULAR/ACR or 2012 SLICC criteria.
  • Active disease despite ≥2 months of stable (≥2 weeks) treatment with glucocorticoids plus immunosuppressants and/or biologics; prednisone ≥7.5 mg/day or equivalent.
  • Positive ANA, anti-dsDNA antibody, and/or anti-Smith antibody at screening.
  • SLEDAI-2K >6 and clinical SLEDAI-2K ≥4 at screening. Patients with lupus nephritis (proteinuria >0.5 g/24h, UPCR >500 mg/g, or active urinary sediment) are exempt from clinical SLEDAI-2K requirement.
  • Physician Global Assessment (PGA) ≥1.0 (0-3 VAS) at screening.
  • For SSc Patients
  • Diagnosis of SSc per 2013 ACR/EULAR criteria.
  • Diffuse cutaneous SSc at screening.
  • Active disease defined by at least one of: new SSc within 2 years; new/worsening skin or thoracic/abdominal involvement within 6 months; worsening skin thickening (mRSS ≥2); tendon friction rubs within 3 months; worsening respiratory symptoms with FVC decline ≥5% predicted or DLCO decline ≥10% predicted; or ILD progression on HRCT compared to 12 months prior.
  • Refractory or relapsing disease after >6 months of conventional therapy including glucocorticoids, cyclophosphamide, immunosuppressants, and/or biologics.
  • For AAV Patients
  • Diagnosis of ANCA-associated vasculitis (MPA, GPA, EGPA) per 2022 ACR/EULAR criteria.
  • Positive MPO-ANCA or PR3-ANCA.
  • BVAS with at least 1 major item, 3 minor items, or 2 renal items.
  • Failure of standard of care: no remission after ≥4 months of glucocorticoids plus cyclophosphamide/rituximab; relapse after prior remission; or persistent active disease despite ≥6 months of SOC.
  • For IIM Patients
  • Diagnosis of IIM (DM, ASS, IMNM) per 2017 ACR/EULAR criteria (probability ≥55%).
  • Active disease defined by ≥2 abnormal core measures, or active myositis on muscle MRI, or active inflammation on muscle biopsy within 16 weeks.
  • Positive myositis-specific autoantibodies.
  • Refractory or relapsing disease after ≥6 months of conventional therapy including glucocorticoids, immunosuppressants, and/or biologics.
  • For pSS Patients
  • Diagnosis of primary Sjögren's syndrome per 2016 ACR/EULAR criteria.
  • Positive anti-SSA/Ro antibody.
  • ESSDAI ≥6 at screening.
  • Refractory or relapsing disease after ≥6 months of conventional therapy including glucocorticoids, immunosuppressants, and/or biologics.

Who cannot join

  • General Exclusion Criteria (All Patients):
  • Coexisting autoimmune disease confounding disease activity/safety (stable ≥3 months may be eligible with approval).
  • Anti-CD20 mAb/T-cell engager within 3 months; CD19/BCMA-targeted therapy within 6 months (exception with CD19⁺ B-cell > LLN and approval).
  • Rapidly progressive glomerulonephritis (RPGN).
  • NYHA III/IV heart failure; severe cardiac disease within 12 months.
  • Severe CNS disease impairing compliance/assessments.
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  • Malignancy history (except cured non-melanoma skin cancer/carcinoma in situ, disease-free ≥3 years).
  • Primary immunodeficiency.
  • Uncontrolled infection (uncomplicated UTI/upper respiratory infection permitted).
  • Positive HIV; positive HCV (except undetectable RNA); positive syphilis.
  • Positive HBsAg; positive HBcAb (except undetectable HBV DNA).
  • Positive EBV/CMV DNA/IgM at screening.
  • Active/recurrent tuberculosis.
  • Prior CAR-T or genetically modified immune cell therapy.
  • Live attenuated vaccine within 4 weeks before enrollment.
  • Hypersensitivity to cell therapy product components.
  • Tacrolimus hypersensitivity or ≥Grade 3 toxicity requiring hospitalization.
  • Other clinical trial participation within 30 days before screening.
  • Pregnant/breastfeeding; childbearing potential unwilling to use effective contraception.
  • Any other ineligible condition (investigator judgment).
  • Exclusion Criteria for SLE
  • Active/unstable neuropsychiatric SLE requiring intervention within 90 days.
  • Anti-BAFF/APRIL therapy within required washout period; multiple NSAIDs within 14 days; inability to hold NSAIDs; intra-articular glucocorticoids within 6 weeks; immunosuppressants exceeding dose limits; hydroxychloroquine dose adjustment within 8 weeks; ACEI/ARB/SGLT2i adjustment within 4 weeks.
  • Exclusion Criteria for AAV
  • Alveolar hemorrhage requiring invasive ventilation beyond screening.
  • Dialysis/plasmapheresis within 12 weeks.
  • Renal transplantation history.
  • Cyclophosphamide within 12 weeks; immunosuppressant discontinuation required 1 week before lymphodepletion.
  • High-dose IV glucocorticoids within 4 weeks.
  • Oral glucocorticoids >60mg prednisone equivalent daily for >6 weeks.
  • Specific immunosuppressants/biologics within 4 weeks.
  • Concomitant strong CYP3A4 inducers.
  • Exclusion Criteria for IIM
  • Severe rhabdomyolysis or CK ≥120×ULN at screening.
  • FVC ≤50% predicted or DLCO ≤40% predicted at screening.
  • Exclusion Criteria for SSc
  • Significant respiratory disease other than ILD.
  • FVC <50% or DLCO <40% predicted at screening/baseline.
  • Lung transplantation listing/expected within 12 months.
  • Scleroderma renal crisis within 6 months.
  • Scleroderma-like disorders.
  • Prior chlorambucil, bone marrow transplantation, or total lymphoid irradiation.
  • Exclusion Criteria for pSS
  • Active fibromyalgia interfering with assessment/requiring medication adjustment (stable permitted).
  • Cyclophosphamide within 12 weeks; immunosuppressant discontinuation required 1 week before lymphodepletion.
  • High-dose glucocorticoids (≥60mg/day) within 4 weeks.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ming Gao, Master contact

+86 177 1418 8689

ming.gao@imvivabio.com

China1 site

  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 220127

    Qiong Fu, Doctor, +86 13585603288, Fuqiong5@163.com

Other trials in China

About this study

Official title: Clinical Study on the Safety, Efficacy and Pharmacokinetics of Universal CD19/BCMA-Targeted CAR-T Cell Injection in Patients With Autoantibody-Mediated Autoimmune Diseases

This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune diseases. The enrolled population consists of patients with active autoimmune diseases, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), ANCA-associated vasculitis (AAV), idiopathic inflammatory myopathies (IIM), Sjögren's syndrome (SS), among others.

The CAR-T cell dose used in this study is 6×10⁶ CAR⁺ T cells/kg. Six subjects will be enrolled for each indication, with a total of 30 subjects to be enrolled.

Being tested
RD06-05 CAR-T Cell Injection
Keywords
CD19/BCMA CAR-T
Medical subject headings
Lupus Erythematosus, Systemic, Scleroderma, Systemic, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Myositis, Sjogren's Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RD06-05 CAR-T Cell InjectionDrug

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

Study groups in NCT07596680
Study groupRoleWhat they receive
RD06-05ExperimentalNot described
Receives: Drug: RD06-05 CAR-T Cell Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SLE (systemic lupus erythematosus)

    Proportion of patients achieving lupus low disease activity state (LLDAS) and DORIS(Definition Of Remission In SLE) remission, as well as the proportion of patients achieving drug-free remission

    Measured: 2 years

  2. SLE (systemic lupus erythematosus)

    Proportion of SLE patients with renal involvement who achieved complete renal response (CRR) and partial renal response

    Measured: 2 years

  3. SLE (systemic lupus erythematosus)

    Change in UPCR(Urine Protein/Creatinine Ratio) from baseline in SLE patients with renal involvement

    Measured: 2 years

  4. SLE (systemic lupus erythematosus)

    Change in eGFR(estimated Glomerular Filtration Rate) from baseline in SLE patients with renal involvement

    Measured: 2 years

  5. SLE (systemic lupus erythematosus)

    Changes in SLEDAI-2K, Physician Global Assessment (PGA), and British Isles Lupus Assessment Group (BILAG) score from baseline

    Measured: 2 years

  6. SLE (systemic lupus erythematosus)

    Changes in anti-dsDNA antibody, C3 and C4 levels from baseline

    Measured: 2 years

  7. AAV (ANCA-associated vasculitis)

    Change in Birmingham Vasculitis Activity Score (BVAS) from baseline. The Birmingham Vasculitis Activity Score (BVAS) ranges from a minimum of 0 to a maximum of 63, with higher scores indicating worse disease activity and clinical outcomes.

    Measured: 2 years

  8. AAV (ANCA-associated vasculitis)

    Proportion of patients with vasculitis relapse (including major flare and minor flare)

    Measured: 2 years

  9. IIM (idiopathic inflammatory myopathies)

    Major clinical remission assessed according to the 2016 ACR/EULAR myopathy remission criteria

    Measured: 2 years

  10. SSc (systemic sclerosis)

    Changes in modified Rodnan Skin Score (mRSS) from baseline

    Measured: 2 years

  11. SSc (systemic sclerosis)

    Changes in European Scleroderma Trials and Research group (EUSTAR) Activity Index from baseline

    Measured: 2 years

  12. SSc (systemic sclerosis)

    Changes in Forced Vital Capacity (FVC) and Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) from baseline in patients complicated with interstitial lung disease

    Measured: 2 years

  13. SS (Sjögren's syndrome )

    Change in ESSDAI(EULAR Sjögren's Syndrome Disease Activity Index) score from baseline. ESSDAI has a score range from 0 to 105, with higher scores indicating greater disease activity and poorer clinical outcomes.

    Measured: 2 years

  14. SS (Sjögren's syndrome )

    Change in ESPRI(EULAR Sjögren's Syndrome Patient Reported Index) score from baseline. ESSPRI ranges from a minimum of 0 to a maximum of 10, with higher scores indicating worse symptoms and poorer patient-reported outcomes.

    Measured: 2 years

  15. SS (Sjögren's syndrome )

    Change in STAR(Sjögren's Tool for Assessing Response) score from baseline. STAR score ranges from 0 to 28, with higher scores indicating more severe disease status and poorer therapeutic response.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Apr 2029 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07596680
Sponsor's protocol ID
BHCT-RD06-05-03
Status last verified
Jul 2026
First submitted
7 Apr 2026
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing RD06-05 CAR-T Cell Injection in people with SLE - Systemic Lupus Erythematosus and Systemic 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 38 inclusion and 46 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: opening soon, as of the sponsor's last update on 16 Jul 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 Ming Gao, Master (+86 177 1418 8689, ming.gao@imvivabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SLE (systemic lupus erythematosus) (time frame: 2 years). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07596680.

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 16 Jul 2026.

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