Autoimmune DiseasesEarly Phase 1NCT07674147

RD06-05 Universal CD19/BCMA CAR-T for Refractory Pediatric Autoimmune Diseases

A Early Phase 1 study testing RD06-05 CART Cell Infusion in people with Autoimmune Diseases and SLE - Systemic Lupus Erythematosus, run by The Children's Hospital of Zhejiang University School of Medicine at 2 sites 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

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Trial summary

Who is it for?: Ages 5 to 20 years
Conditions the study is for: Autoimmune Diseases, SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis
What is being tested?: RD06-05 CART Cell Infusion
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 2 sitesChina
Study dates: Jul 2026to Jul 2030
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 5 to 20 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Voluntary participation with signed informed consent from patient or legal guardian.
Age >=5 to <20 years, male or female.
Important organ function meeting the following requirements (excluding abnormalities related to autoimmune disease activity): a) Bone marrow: ANC >=1.0x10^9/L, hemoglobin >=60 g/L, platelets >=30x10^9/L; b) Liver: ALT <=3xULN (except IIM-related elevation), AST <=3xULN, total bilirubin <=2xULN (<=3xULN for Gilbert syndrome); c) Kidney: eGFR >=30 mL/min/1.73m^2 (lower eGFR or on renal replacement may be allowed if benefit > risk by investigator judgment); d) Cardiac: LVEF >=55% by echocardiogram; e) Pulmonary: No severe lung disease, SpO2 >=92%.
Negative serum or urine pregnancy test for females of childbearing potential at screening.
Females of childbearing potential must use highly effective contraception from at least 28 days before lymphodepletion through 12 months post-infusion. Males must use effective barrier contraception and not donate sperm from start of lymphodepletion through 12 months post-infusion.
Disease-Specific Inclusion Criteria for SLE/LN:

Show all 28Show fewer

Diagnosis of SLE by 2019 EULAR/ACR or 2012 SLICC criteria.
If renal involvement: kidney biopsy within 2 years showing active nephritis (class III, IV, V, or combination). Renal involvement defined as proteinuria >0.15g/24h, or hematuria, or eGFR <90.Inadequate response to standard therapy: high-dose glucocorticoid (>=1 mg/kg/d prednisone equivalent) + hydroxychloroquine + at least 2 DMARDs for 3 months, or intolerance, or unable to taper steroid to <=5 mg/day at 6 months.
Positive ANA, anti-dsDNA, or anti-Smith antibody.
SLEDAI-2K >=8 and clinical SLEDAI-2K >=4 (renal proteinuria >0.5g/24h or UPCR >500 mg/g or active urinary sediment may waive the clinical SLEDAI-2K requirement).
Physician Global Assessment (PGA) >=1.0 (0-3 VAS).
Disease-Specific Inclusion Criteria for SSc:
Diagnosis of SSc by 2013 ACR/EULAR criteria.
Diffuse cutaneous SSc.
Evidence of active disease (e.g., new SSc within 2 years, new skin involvement or worsening mRSS within 6 months, tendon friction rubs, lung function decline, ILD progression).
FVC >=50% and DLCO >=45% predicted.
Failed or relapsed on conventional therapy (glucocorticoid >0.5 mg/kg/d prednisone equivalent + at least two immunomodulators for >6 months).
Disease-Specific Inclusion Criteria for IIM:
Diagnosis of IIM (dermatomyositis, antisynthetase syndrome, IMNM) by 2017 ACR/EULAR criteria (probability >=55%).
Active disease: at least 2 of 6 core set abnormalities (MMT-8<142, PhGA >=2 cm, PtGA >=2 cm, extra-muscular MDAAT >=2 cm, PedsQL >=60, CK >=1.5xULN).
Positive myositis-specific autoantibody.
Failed or relapsed on conventional therapy (glucocorticoid >1 mg/kg/d prednisone equivalent + at least 2 immunomodulators for >=6 months).
Disease-Specific Inclusion Criteria for IgAN:
Biopsy-confirmed IgA nephropathy.
On ACEi/ARB for >=3 months, and at least one of: a) proteinuria >=500 mg/24h or UPCR >=0.5 mg/mg after >=3 months of steroid + at least one immunosuppressant/biologic; b) eGFR decline >50% within 3 months; c) 22.intolerance to conventional therapy with benefit > risk.
Disease-Specific Inclusion Criteria for MDR-NS:
23.Meets 2025 KDIGO definition of steroid-resistant nephrotic syndrome. 24.At least one of: a) failed to achieve remission after 12 months of two different mechanism steroid-sparing agents (at least one calcineurin inhibitor); b) no remission after 3-6 months of one CNI with benefit > risk; c) intolerance to conventional therapy; d) coexisting systemic disease requiring long-term immunosuppression.
25.Prior kidney biopsy showing minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS).

Who cannot join

Co-existing autoimmune disease that may interfere with disease activity attribution or add safety risk (unless stable >=3 months and approved).
Prior B-cell/ASC depletion therapy: a) Anti-CD20 or T-cell engager within 3 months (allowed if >3-6 months and CD19+ B-cells > LLN); b) Prior CD19 and BCMA dual-targeted therapy, or CD19 or BCMA targeted therapy within 6 months (allowed if >6 months and B-cells > LLN); c) Other B-cell/ASC targeted therapies require approval.
Rapidly progressive glomerulonephritis (RPGN): >=50% crescents on biopsy, or doubling of serum creatinine within 2 months, or investigator judgment.
Cardiac disease: NYHA class III/IV heart failure, MI, angioplasty/stent, unstable angina, or other severe cardiac disease within 12 months.
Severe CNS disease (traumatic brain injury, impaired consciousness, epilepsy, cerebrovascular ischemia/hemorrhage) that may affect compliance or assessment.
Malignancy history except cured non-melanoma skin cancer or carcinoma in situ, unless disease-free for >=3 years.

Show all 44Show fewer

Primary immunodeficiency.
Uncontrolled infection (simple UTI or upper respiratory infection allowed).
Known history of HIV, hepatitis C, or syphilis infection.
Active or latent hepatitis B infection.
Positive EBV or CMV DNA or IgM at screening.
History of recurrent tuberculosis.
Prior CAR-T or other transgenic immune cell therapy.
Live attenuated vaccine within 4 weeks before enrollment.
Allergy to any component of the cell therapy product.
Hypersensitivity to tacrolimus or prior grade >=3 tacrolimus-related toxicity requiring hospitalization (exceptions may be approved).
Participation in another clinical trial within 30 days before screening.
Pregnancy, breastfeeding, or unwillingness to use effective contraception.
Any other condition judged by investigator as unsuitable for study.
Disease-Specific Exclusion Criteria for SLE:
Active/unstable neuropsychiatric lupus (seizures, psychosis, organic brain syndrome, CVA, encephalitis, CNS vasculitis) within 90 days requiring intervention.
Prior treatments: belimumab/telitacicept within 4 weeks; ianalumab within 8 weeks unless B-cells > LLN; >1 systemic NSAID within 14 days; inability to wash out NSAID before disease activity assessment; intra-articular/IM glucocorticoid within 6 weeks; immunosuppressant doses above specified limits; initiation or dose change of hydroxychloroquine within 8 weeks; ACEi/ARB/SGLT2 inhibitor dose change within 4 weeks.
Disease flare requiring increased corticosteroids (>20 mg/day prednisone equivalent) or new immunosuppression during screening.
Disease-Specific Exclusion Criteria for IIM:
Severe rhabdomyolysis or CK >=20xULN.
FVC <=60% predicted, or DLCO <=70% predicted, or worsening lung function compared to prior 3-12 months.
Disease-Specific Exclusion Criteria for SSc:
Anti-centromere antibody positive without ATA or anti-RNAP3.
Clinically significant respiratory disease other than ILD (severe COPD, severe asthma, recent severe respiratory infection, smoking).
FVC <50% or DLCO <40% predicted.
On lung transplant list or expected within 12 months.
History of scleroderma renal crisis within 6 months.
SSc-like disorders (morphea, eosinophilic fasciitis, etc.).
Antifibrotic drugs within 4 weeks (colchicine, D-penicillamine, pirfenidone, tyrosine kinase inhibitors).
Prior chlorambucil, bone marrow transplant, or total lymphoid irradiation.
Disease-Specific Exclusion Criteria for IgAN:
Secondary IgAN (cirrhosis, celiac disease, HIV, malignancy).
Other cause of chronic kidney disease (diabetic nephropathy, other primary glomerulopathy) that may interfere.
Uncontrolled blood pressure.
Prior treatments: hydroxychloroquine dose change within 8 weeks; biologics (infliximab, eculizumab, canakinumab) within 4 weeks; prednisone >30 mg/day or unstable dose; endothelin receptor antagonist within 4 weeks before lymphodepletion.
Disease-Specific Exclusion Criteria for MDR-NS:
Secondary nephrotic syndrome/proteinuria (infection-related, drug-related, systemic disease) that may interfere.
On maintenance dialysis, need for immediate renal replacement, or expected dialysis/transplant within 12 months.
Prior treatments: ACEi/ARB dose change within 4 weeks; glucocorticoid dose adjustment within 2 weeks or need for >10 mg/day prednisone equivalent; 40.disease flare requiring increased steroids (>10 mg/day) or new immunosuppression during screening.

Trial locations and contacts

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

Jianhua Mao contact

+86 13516819071

maojh88@zju.edu.cn

China2 sites

Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
Jianhua Mao, +86 13516819071, maojh88@zju.edu.cn
Nanjing Children's Hospital
Nanjing, Jiangsu, 210000
Haiguo Yu, 025-83117500, njetyy@njch.com.cn

Other trials in China

About this study

Official title: A Clinical Study of the Safety, Efficacy, and Pharmacokinetics of Universal CD19/BCMA-Targeted CAR-T Cell Injection for the Treatment of Autoimmune Diseases in Children and Adolescents

This is a single-arm, open-label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05, a universal CD19/BCMA dual-targeting chimeric antigen receptor T-cell (CAR-T), in pediatric and adolescent patients with refractory autoimmune diseases, including systemic lupus erythematosus/lupus nephritis (SLE/LN), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), multidrug-resistant nephrotic syndrome (MDR-NS), and refractory IgA nephropathy (IgAN).

Approximately 30 eligible patients will be enrolled and receive a single intravenous infusion of RD06-05 at an initial dose of 6×10⁶ CAR+ T cells/kg, with a potential dose escalation to 10×10⁶ CAR+ T cells/kg following review by a Safety Review Committee (SRC).

Read the detailed description

Study Duration:

Approximately 4 years (2026-2030), with individual participant participation lasting up to 24 months post-infusion.

Follow-up:

Patients are followed for safety, efficacy, PK/PD, and quality of life assessments at predefined time points through 24 months post-infusion.

Key Endpoints:

Primary: Incidence of TEAEs, SAEs, and AESIs (including cytokine release syndrome, ICANS, GvHD, infections, and secondary malignancies).

Secondary: Disease-specific response rates (e.g., LLDAS/DORIS for SLE/LN, mRSS for SSc, MMT-8 for IIM, UPCR for IgAN, remission for MDR-NS), changes in eGFR, autoantibody levels, quality of life (PedsQL 4.0), CAR-T expansion (Cmax, AUC0-28), persistence, and anti-drug antibody incidence.

Exploratory: B-cell aplasia duration and B-cell subset reconstitution.

Conditions: Autoimmune Diseases, SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis, IIM- Idiopathic Inflammatory Myopathies, IgAN - IgA Nephropathy, Multi-Drug Resistant Nephrotic Syndrome
Being tested: RD06-05 CART Cell Infusion
Medical subject headings: Autoimmune Diseases, Lupus Erythematosus, Systemic, Glomerulonephritis, IGA, Nephrotic Syndrome

What participants receive

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

RD06-05 CART Cell InfusionDrug
CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.

Study groups in NCT07674147
Study group	Role	What they receive
RD06-05 Universal CAR-T Therapy	Experimental	Single-arm, open-label: participants receive a single intravenous infusion of RD06-05 (universal CD19/BCMA dual-targeting CAR-T cells) following a lymphodepleting regimen of fludarabine and cyclophosphamide. Receives: Drug: RD06-05 CART 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 (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Incidence of TEAEs, SAEs, and AESIs following RD06-05 infusion. AESIs include cytokine release syndrome (CRS) of grade ≥3, immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade, graft-versus-host disease (GvHD) of any grade, infections of grade ≥3, secondary malignancies of any grade, and cardiac disorders of any grade.
Measured: From signing of informed consent through 90 days post-infusion (for related AEs, up to 24 months post-infusion)

Secondary outcomes (24)

Proportion of SLE/LN Patients Achieving LLDAS and DORIS Remission
Proportion of patients with systemic lupus erythematosus/lupus nephritis (SLE/LN) who achieve Lupus Low Disease Activity State (LLDAS) and DORIS remission, including drug-free remission.
Measured: 2 years
Renal Response in SLE/LN Patients with Renal Involvement
Proportion of SLE/LN patients with renal involvement achieving complete renal response (CRR) and partial response, and change from baseline in UPCR (urine protein-to-creatinine ratio) and eGFR.
Measured: 2 years
Change in SLE Disease Activity Scores
Change from baseline in SLEDAI-2K score(range from 0 to105, higher scores mean a worse outcome).
Measured: 2 years
Change in SLE Disease Activity Scores
Change from baseline in Physician Global Assessment (PGA : range from 0 to 3, higher scores mean a worse outcome).
Measured: 2years
Change in SLE Disease Activity Scores
Change from baseline in British Isles Lupus Assessment Group (BILAG) score ( range from A to E, higher grade means a better outcome)..
Measured: 2years
Change in Autoantibody Levels in SLE/LN
Change from baseline in anti-dsDNA antibody levels.
Measured: 2 years
Change in Complement Levels in SLE/LN
Change from baseline in c omplement(C3/C4) levels.
Measured: 2 years
Major Clinical Response in IIM Patients
Proportion of patients with idiopathic inflammatory myopathy (IIM) achieving major clinical response according to 2016 ACR/EULAR myositis response criteria
Measured: 2 years
Change in Skin and Lung Function in SSc Patients
Change from baseline in modified Rodnan skin score (mRSS) , for patients with interstitial lung disease, change from baseline in FVC and DLCO.
Measured: 2 years
Change in Skin and Lung Function in SSc Patients
Change from baseline in EUSTAR activity index; for patients with interstitial lung disease, change from baseline in FVC and DLCO.
Measured: 2 years
Remission and Renal Outcomes in MDR-NS Patients
Proportion of patients with complete remission (CR), partial remission (PR), and overall response rate (CR+PR); change from baseline in serum albumin and eGFR; time to first composite renal outcome event (sustained eGFR decline ≥30%, eGFR <15 mL/min/1.73m², maintenance dialysis/kidney transplant, or renal death).
Measured: 2 years
Change in Quality of Life (PedsQL 4.0)
Change from baseline in Pediatric Quality of Life Inventory (PedsQL 4.0) score ( range from 0 to 100, higher scores mean a better outcome)..
Measured: 2 years
Pharmacokinetics - CAR-T Expansion
Peak expansion (Cmax) of RD06-05 CAR-T cells in peripheral blood.
Measured: 2 years
Immunogenicity - Anti-Drug Antibodies (ADA)
Incidence of anti-drug antibodies (ADA) specific to RD06-05.
Measured: 2 years
Proteinuria in IgAN Patients
Proportion of patients achieving UPCR < 1 g/g.
Measured: 2 years
Proteinuria in IgAN Patients
Change from baseline in UPCR
Measured: 2 years
Renal Function in IgAN Patients
Change from baseline in eGFR.
Measured: 2 years.
Renal Function in IgAN Patients
Change from baseline in eGFR slope.
Measured: 2 years
Renal Function in IgAN Patients
Proportion with eGFR decline ≥30%
Measured: 2 years
Renal Function in IgAN Patients
Time to first composite kidney failure endpoint (sustained eGFR decline ≥30%, eGFR <15 mL/min/1.73m², maintenance dialysis, kidney transplant, or renal death).
Measured: 2 years
Duration of peripheral blood B-cell aplasia
Duration of peripheral blood B-cell aplasia following RD06-05 infusion.
Measured: 2 years
Pharmacokinetics - CAR-T Expansion
Area under the curve from day 0 to day 28 (AUC0-28) of RD06-05 CAR-T cells in peripheral blood.
Measured: 2 years
Pharmacokinetics - CAR-T Persistence
Persistence of RD06-05 CAR-T cells in peripheral blood.
Measured: 2 years
Immunogenicity - Anti-Drug Antibodies (ADA)
Titer of anti-drug antibodies (ADA) specific to RD06-05.
Measured: 2 years

Timeline

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

Jul 2026Jul 2030

First posted29 Jun 2026
Study startJul 2026 (estimated)
Primary completionJul 2029 (estimated)
Study completionJul 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Autoimmune DiseasesStudies 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: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07674147
Sponsor's protocol ID: BHCT-RD06-05-PAID
Status last verified: Jun 2026
First submitted: 5 Jun 2026
Last updated: 29 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Jianhua Mao

+86 13516819071

maojh88@zju.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study of the Safety, Efficacy, and Pharmacokinetics of Universal CD19/BCMA-Targeted CAR-T Cell Injection for the Treatment of Autoimmune Diseases in Children and Adolescents
ClinicalTrials.gov ID: NCT07674147
Acronym / sponsor ID: BHCT-RD06-05-PAID
Conditions: Autoimmune Diseases, SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis, IIM- Idiopathic Inflammatory Myopathies, IgAN - IgA Nephropathy, Multi-Drug Resistant Nephrotic Syndrome
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
Study start: Jul 2026 (estimated)
Primary completion: Jul 2029 (estimated)
Study completion: Jul 2030 (estimated)
First posted: 29 Jun 2026 (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.

Detailed description

Study Duration:

Approximately 4 years (2026-2030), with individual participant participation lasting up to 24 months post-infusion.

Follow-up:

Patients are followed for safety, efficacy, PK/PD, and quality of life assessments at predefined time points through 24 months post-infusion.

Key Endpoints:

Primary: Incidence of TEAEs, SAEs, and AESIs (including cytokine release syndrome, ICANS, GvHD, infections, and secondary malignancies).

Exploratory: B-cell aplasia duration and B-cell subset reconstitution.

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 Universal CAR-T Therapy	Experimental	Drug: RD06-05 CART Cell InfusionSingle-arm, open-label: participants receive a single intravenous infusion of RD06-05 (universal CD19/BCMA dual-targeting CAR-T cells) following a lymphodepleting regimen of fludarabine and cyclophosphamide.

Who may qualify

Ages: 5 to 20 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (28 listed)

Voluntary participation with signed informed consent from patient or legal guardian.
Age >=5 to <20 years, male or female.
Important organ function meeting the following requirements (excluding abnormalities related to autoimmune disease activity): a) Bone marrow: ANC >=1.0x10^9/L, hemoglobin >=60 g/L, platelets >=30x10^9/L; b) Liver: ALT <=3xULN (except IIM-related elevation), AST <=3xULN, total bilirubin <=2xULN (<=3xULN for Gilbert syndrome); c) Kidney: eGFR >=30 mL/min/1.73m^2 (lower eGFR or on renal replacement may be allowed if benefit > risk by investigator judgment); d) Cardiac: LVEF >=55% by echocardiogram; e) Pulmonary: No severe lung disease, SpO2 >=92%.
Negative serum or urine pregnancy test for females of childbearing potential at screening.
Females of childbearing potential must use highly effective contraception from at least 28 days before lymphodepletion through 12 months post-infusion. Males must use effective barrier contraception and not donate sperm from start of lymphodepletion through 12 months post-infusion.

Key exclusion criteria (44 listed)

Co-existing autoimmune disease that may interfere with disease activity attribution or add safety risk (unless stable >=3 months and approved).
Prior B-cell/ASC depletion therapy: a) Anti-CD20 or T-cell engager within 3 months (allowed if >3-6 months and CD19+ B-cells > LLN); b) Prior CD19 and BCMA dual-targeted therapy, or CD19 or BCMA targeted therapy within 6 months (allowed if >6 months and B-cells > LLN); c) Other B-cell/ASC targeted therapies require approval.
Rapidly progressive glomerulonephritis (RPGN): >=50% crescents on biopsy, or doubling of serum creatinine within 2 months, or investigator judgment.
Cardiac disease: NYHA class III/IV heart failure, MI, angioplasty/stent, unstable angina, or other severe cardiac disease within 12 months.
Severe CNS disease (traumatic brain injury, impaired consciousness, epilepsy, cerebrovascular ischemia/hemorrhage) that may affect compliance or assessment.

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 InfusionCAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.	Drug	RD06-05 Universal CAR-T Therapy

Primary outcome

Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Time frame: From signing of informed consent through 90 days post-infusion (for related AEs, up to 24 months post-infusion)
Incidence of TEAEs, SAEs, and AESIs following RD06-05 infusion. AESIs include cytokine release syndrome (CRS) of grade ≥3, immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade, graft-versus-host disease (GvHD) of any grade, infections of grade ≥3, secondary malignancies of any grade, and cardiac disorders of any grade.

24 secondary outcomes

Proportion of SLE/LN Patients Achieving LLDAS and DORIS Remission
Time frame: 2 years
Renal Response in SLE/LN Patients with Renal Involvement
Time frame: 2 years
Change in SLE Disease Activity Scores
Time frame: 2 years
Change in SLE Disease Activity Scores
Time frame: 2years
Change in SLE Disease Activity Scores
Time frame: 2years
Change in Autoantibody Levels in SLE/LN
Time frame: 2 years
Change in Complement Levels in SLE/LN
Time frame: 2 years
Major Clinical Response in IIM Patients
Time frame: 2 years
Change in Skin and Lung Function in SSc Patients
Time frame: 2 years
Change in Skin and Lung Function in SSc Patients
Time frame: 2 years
Remission and Renal Outcomes in MDR-NS Patients
Time frame: 2 years
Change in Quality of Life (PedsQL 4.0)
Time frame: 2 years
Pharmacokinetics - CAR-T Expansion
Time frame: 2 years
Immunogenicity - Anti-Drug Antibodies (ADA)
Time frame: 2 years
Proteinuria in IgAN Patients
Time frame: 2 years
Proteinuria in IgAN Patients
Time frame: 2 years
Renal Function in IgAN Patients
Time frame: 2 years.
Renal Function in IgAN Patients
Time frame: 2 years
Renal Function in IgAN Patients
Time frame: 2 years
Renal Function in IgAN Patients
Time frame: 2 years
Duration of peripheral blood B-cell aplasia
Time frame: 2 years
Pharmacokinetics - CAR-T Expansion
Time frame: 2 years
Pharmacokinetics - CAR-T Persistence
Time frame: 2 years
Immunogenicity - Anti-Drug Antibodies (ADA)
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 29 Jun 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.

Jianhua Mao contact

+86 13516819071

maojh88@zju.edu.cn

Jianhua Mao principal investigator

The Children's Hospital of Zhejiang University School of Medicine

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 28 inclusion and 44 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 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Jianhua Mao (+86 13516819071, maojh88@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) (time frame: From signing of informed consent through 90 days post-infusion (for related AEs, up to 24 months post-infusion)). 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 NCT07674147.

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 29 Jun 2026.