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Not yet recruitingNCT07674147Updated Jun 29, 2026

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

An Early Phase 1 interventional study of RD06-05 CART Cell Infusion in Autoimmune Diseases, SLE - Systemic Lupus Erythematosus and SSc-Systemic Sclerosis, sponsored by The Children's Hospital of Zhejiang University School of Medicine. Not yet recruiting at 2 sites in China. Open to participants aged 5 Years to 20 Years. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by The Children's Hospital of Zhejiang University School of Medicine · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
5 Years to 20 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Autoimmune Diseases
  • SLE - Systemic Lupus Erythematosus
  • SSc-Systemic Sclerosis
  • IIM- Idiopathic Inflammatory Myopathies
  • IgAN - IgA Nephropathy
  • Multi-Drug Resistant Nephrotic Syndrome
03

In context

Autoimmune Diseases

802 studies on the registry are indexed under Autoimmune Diseases; 271 are open to participants now.

This study's planned enrollment of 30 is below the median of 40 across 541 interventional studies indexed under Autoimmune Diseases.

Browse Autoimmune Diseases studies →

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine is the lead sponsor of 69 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Voluntary participation with signed from patient or legal guardian.
  2. Age >=5 to \<20 years, male or female.
  3. Important organ function meeting the following requirements (excluding abnormalities related to disease activity): a) Bone marrow: >=1.0x10\^9/L, >=60 g/L, >=30x10\^9/L; b) Liver: \<=3xULN (except IIM-related elevation), AST \<=3xULN, total \<=2xULN (\<=3xULN for Gilbert syndrome); c) Kidney: >=30 mL/min/1.73m\^2 (lower eGFR or on renal replacement may be allowed if benefit > risk by investigator judgment); d) Cardiac: >=55% by echocardiogram; e) Pulmonary: No severe lung disease, SpO2 >=92%.
  4. Negative serum or urine pregnancy test for females of at screening.

  5. Females of childbearing potential must use highly effective 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:

  6. Diagnosis of SLE by 2019 EULAR/ACR or 2012 SLICC criteria.
  7. If renal involvement: kidney 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 (>=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.
  8. Positive ANA, anti-dsDNA, or anti-Smith antibody.
  9. 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).

  10. Physician Global Assessment (PGA) >=1.0 (0-3 VAS).

    Disease-Specific Inclusion Criteria for SSc:

  11. Diagnosis of SSc by 2013 ACR/EULAR criteria.
  12. Diffuse cutaneous SSc.
  13. 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).
  14. FVC >=50% and DLCO >=45% predicted.

  15. Failed or on conventional therapy (glucocorticoid >0.5 mg/kg/d prednisone equivalent + at least two immunomodulators for >6 months).

    Disease-Specific Inclusion Criteria for IIM:

  16. Diagnosis of IIM (dermatomyositis, antisynthetase syndrome, IMNM) by 2017 ACR/EULAR criteria (probability >=55%).
  17. 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).
  18. Positive myositis-specific autoantibody.

  19. 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:

  20. Biopsy-confirmed IgA nephropathy.
  21. 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 /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).

Exclusion criteria

Exclusion Criteria:

  1. Co-existing disease that may interfere with disease activity attribution or add safety risk (unless stable >=3 months and approved).
  2. 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.
  3. Rapidly progressive glomerulonephritis (RPGN): >=50% crescents on , or doubling of serum creatinine within 2 months, or investigator judgment.
  4. Cardiac disease: class III/IV heart failure, MI, angioplasty/stent, unstable angina, or other severe cardiac disease within 12 months.
  5. Severe CNS disease (traumatic brain injury, impaired consciousness, epilepsy, cerebrovascular ischemia/hemorrhage) that may affect compliance or assessment.
  6. history except cured non-melanoma skin cancer or carcinoma in situ, unless disease-free for >=3 years.
  7. Primary immunodeficiency.
  8. Uncontrolled infection (simple UTI or upper respiratory infection allowed).
  9. Known history of , , or syphilis infection.
  10. Active or latent infection.
  11. Positive EBV or CMV DNA or IgM at screening.
  12. History of recurrent tuberculosis.
  13. Prior CAR-T or other transgenic immune cell therapy.
  14. within 4 weeks before enrollment.
  15. Allergy to any component of the cell therapy product.
  16. to tacrolimus or prior grade >=3 tacrolimus-related toxicity requiring hospitalization (exceptions may be approved).
  17. Participation in another clinical trial within 30 days before screening.
  18. Pregnancy, breastfeeding, or unwillingness to use effective .

  19. Any other condition judged by investigator as unsuitable for study.

    Disease-Specific Exclusion Criteria for SLE:

  20. Active/unstable neuropsychiatric lupus (seizures, psychosis, organic brain syndrome, CVA, encephalitis, CNS vasculitis) within 90 days requiring intervention.
  21. 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 within 6 weeks; doses above specified limits; initiation or dose change of hydroxychloroquine within 8 weeks; ACEi/ARB/SGLT2 inhibitor dose change within 4 weeks.

  22. Disease flare requiring increased corticosteroids (>20 mg/day prednisone equivalent) or new immunosuppression during screening.

    Disease-Specific Exclusion Criteria for IIM:

  23. Severe rhabdomyolysis or CK >=20xULN.

  24. FVC \<=60% predicted, or DLCO \<=70% predicted, or worsening lung function compared to prior 3-12 months.

    Disease-Specific Exclusion Criteria for SSc:

  25. Anti-centromere antibody positive without ATA or anti-RNAP3.
  26. respiratory disease other than ILD (severe , severe asthma, recent severe respiratory infection, smoking).
  27. FVC \<50% or DLCO \<40% predicted.
  28. On lung transplant list or expected within 12 months.
  29. History of scleroderma renal crisis within 6 months.
  30. SSc-like disorders (morphea, eosinophilic fasciitis, etc.).
  31. Antifibrotic drugs within 4 weeks (colchicine, D-penicillamine, pirfenidone, tyrosine kinase inhibitors).

  32. Prior chlorambucil, bone marrow transplant, or total lymphoid irradiation.

    Disease-Specific Exclusion Criteria for IgAN:

  33. Secondary IgAN (cirrhosis, celiac disease, HIV, malignancy).
  34. Other cause of chronic kidney disease (diabetic nephropathy, other primary glomerulopathy) that may interfere.
  35. Uncontrolled blood pressure.

  36. 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:

  37. Secondary nephrotic syndrome/proteinuria (infection-related, drug-related, systemic disease) that may interfere.
  38. On maintenance dialysis, need for immediate renal replacement, or expected dialysis/transplant within 12 months.
  39. 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.
Terms in these criteria, in plain language(24)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    RD06-05 Universal CAR-T Therapy

    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.

    Drug: RD06-05 CART Cell Infusion

Interventions

  • DrugRD06-05 CART Cell Infusion

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From signing of informed consent through 90 days post-infusion (for related AEs, up to 24 months post-infusion)

Secondary outcomes

  1. 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.

    Time frame: 2 years

  2. 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.

    Time frame: 2 years

  3. Change in SLE Disease Activity Scores

    Change from baseline in SLEDAI-2K score(range from 0 to105, higher scores mean a worse outcome).

    Time frame: 2 years

  4. 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).

    Time frame: 2years

  5. 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)..

    Time frame: 2years

  6. Change in Autoantibody Levels in SLE/LN

    Change from baseline in anti-dsDNA antibody levels.

    Time frame: 2 years

  7. Change in Complement Levels in SLE/LN

    Change from baseline in c omplement(C3/C4) levels.

    Time frame: 2 years

  8. 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

    Time frame: 2 years

  9. 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.

    Time frame: 2 years

  10. 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.

    Time frame: 2 years

  11. 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).

    Time frame: 2 years

  12. 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)..

    Time frame: 2 years

  13. Pharmacokinetics - CAR-T Expansion

    Peak expansion (Cmax) of RD06-05 CAR-T cells in peripheral blood.

    Time frame: 2 years

  14. Immunogenicity - Anti-Drug Antibodies (ADA)

    Incidence of anti-drug antibodies (ADA) specific to RD06-05.

    Time frame: 2 years

  15. Proteinuria in IgAN Patients

    Proportion of patients achieving UPCR \< 1 g/g.

    Time frame: 2 years

  16. Proteinuria in IgAN Patients

    Change from baseline in UPCR

    Time frame: 2 years

  17. Renal Function in IgAN Patients

    Change from baseline in eGFR.

    Time frame: 2 years.

  18. Renal Function in IgAN Patients

    Change from baseline in eGFR slope.

    Time frame: 2 years

  19. Renal Function in IgAN Patients

    Proportion with eGFR decline ≥30%

    Time frame: 2 years

  20. 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).

    Time frame: 2 years

  21. Duration of peripheral blood B-cell aplasia

    Duration of peripheral blood B-cell aplasia following RD06-05 infusion.

    Time frame: 2 years

  22. 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.

    Time frame: 2 years

  23. Pharmacokinetics - CAR-T Persistence

    Persistence of RD06-05 CAR-T cells in peripheral blood.

    Time frame: 2 years

  24. Immunogenicity - Anti-Drug Antibodies (ADA)

    Titer of anti-drug antibodies (ADA) specific to RD06-05.

    Time frame: 2 years

Other outcomes

  1. Incidence of B-Cell Aplasia

    Incidence of peripheral blood B-cell aplasia following RD06-05 infusion.

    Time frame: 2 years

  2. Changes in B-Cell Subsets

    Changes in peripheral blood B-cell subsets.

    Time frame: 2 years

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Jul 2029, 36 months later.

Of 94 phase 1 interventional studies under Autoimmune Diseases, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 36. This study's planned 36 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2026
First posted
Jun 29, 2026
StartEst.
Jul 2026
Primary completionEst.
Jul 2029
CompletionEst.
Jul 2030
Last update
Jun 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07674147
Lead sponsor
The Children's Hospital of Zhejiang University School of Medicine
Responsible party
Mao Jianhua (Professor, The Children's Hospital of Zhejiang University School of Medicine) — Principal investigator
First posted
Jun 29, 2026
Start date
Jul 2026 (estimated)
Primary completion
Jul 2029 (estimated)
Completion
Jul 2030 (estimated)
Last update
Jun 29, 2026

Study contacts

Jianhua Mao
Contact
maojh88@zju.edu.cn
+86 13516819071
Jianhua Mao
principal investigator · The Children's Hospital of Zhejiang University School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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