Juvenile Dermatomyositis (JDM)Phase 1NCT07184450
Clinical Study of BCMA/CD70-targeted CAR-T Therapy for Refractory Pediatric Rheumatic Diseases
A Phase 1 study testing BCMA/CD70-targetd CAR-T in people with Juvenile Dermatomyositis (JDM) and Polyarticular Juvenile Idiopathic Arthritis, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.
Trial summary
This is an investigator-initiated trial to evaluate the efficacy and safety of BCMA/CD70-targeted CAR-T in the treatment of refractory pediatric rheumatic diseases. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Juvenile Dermatomyositis (JDM), Polyarticular Juvenile Idiopathic Arthritis, Systemic Sclerosis (SSc)
- What is being tested?
- BCMA/CD70-targetd CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 30 Sep 2028
- Phase
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥5 years old.
- To meet the diagnostic criteria of refractory B-cell-related pediatric rheumatic diseases, including but not limited to juvenile dermatomyositis, polyarticular juvenile idiopathic arthritis, systemic sclerosis, and primary Sjogren's syndrome.
- Diagnosed as juvenile dermatomyositis(JDM) according to the criteria of Bohan and Peter, and meeting the following conditions:
- The classification criteria of RJDM must meet (1) and any one of (2)-(5): (1) Patients who are intolerant or unresponsive to glucocorticoids and at least 2 immunosuppressants, and the duration of adequate hormone therapy should be at least 6 months; (2) The disease progresses rapidly and/or involves organs such as lungs, heart and gastrointestinal tract; (3) Calcification of subcutaneous or muscle and joint tissues; (4) Repeated rashes or skin ulcers; (5) Repeated or persistent myasthenia(muscle MRI indicates extensive, diffuse edema or the Childhood Myositis Assessment Scale(CMAS) should be less than 48 points, and at least two of the following five core measurement indicators should have abnormal results: Physician Global Assessment(PhGA) ≥2cm, Patient Global Assessment(PtGA) ≥2cm, Disease Activity Score(DAS) ≥2 points, Childhood Health Assessment Questionnaire(C-HAQ) ≥0.25 points, muscle enzyme level > 1.5×upper limit of normal);
- RJDM with anti-synthetase syndrome who are positive for anti-synthetase antibody and those with immune-mediated necrotizing myopathy who are positive for SRP or HMGCR antibody can be included.
- Meet the classification criteria for polyarticular juvenile idiopathic arthritis as defined by the International League of Associations for Rheumatology(ILAR) classification in 2001, and meeting the following conditions: After at least 6 months of traditional DMARDS treatment and at least one stable dose of DMARDS or biologic agent for ≥12 weeks, the disease is still active, that is, there are at least 2 active joints (defined as swollen joints; if there is no swelling, there must be limited passive range of motion, accompanied by pain during movement or joint tenderness).
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- Meet the classification criteria for Systemic sclerosis (SSc) as defined by the 2013ACR/EULAR standards, and meeting the following conditions:
- Meet the definition of intractable disease: Glucocorticoids (≥0.5mg/kg/d) and cyclophosphamide, as well as one or more of the following immunomodulators (including antimalarial drugs, azathioprine,mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, beliumab, and telitacicept, etc.), did not show significant remission of the disease for more than 3 months; Or meet the criteria for rapid disease progression , clinical routine treatment is ineffective, and the benefits outweigh the risks as determined by the investigator and the patient's or guardian's full and informed consent can be considered for inclusion;
- Modified Rodnan Skin Score (mRSS) ≥15 points (total 51 points).
- Meet the classification criteria for primary Sjogren's syndrome as defined by the 2002 ACEG classification criteria /2016 EULAR/ACR classification criteria, and meeting the following conditions:
- Meet (1) and any one of (2)-(6): (1) For those who are intolerant or have an insufficient response to glucocorticoid (prednisone 1-2 mg/kg/d or an equivalent dose of other hormones) and at least two immunosuppressants, the duration of hormone treatment should be at least 6 months; (2) The disease progresses rapidly and/or involves organs such as the kidneys, nervous system, and lungs; (3) Repeated parotid gland swelling or repeated parotitis; (4) Recurrent rashes or skin ulcers; (5) Involvement of the blood system, repeated leukopenia, anemia or thrombocytopenia; (6) cryoglobulinemia;
- Positive for anti-SSA /Ro antibody;
- ESSDAI score ≥5 points or clinESSDAI score ≥5 points.
- Positive expression of CD19 in peripheral blood B cells determined by flow cytometry, and B cells > 5 per/uL.
- Previously not treated with CAR-T; or recurrence or poor efficacy after previous autologous or universal CD19-targeted CAR-T treatment (evaluated by the researcher).
- The functions of important organs are basically normal:
- Cardiac function: left ventricular ejection fraction (LVEF) ≥55%, no obvious abnormality in electrocardiogram;
- Renal function: eGFR≥30mL/min/1.73m2;
- Liver function: AST and ALT≤3.0 ULN, total bilirubin ≤2.0×ULN;
- Lung function: SpO2≥92%.
- Meet standards for leukapheresis or intravenous blood collection, and no other contraindications for leukapheresis.
- The subject of childbearing age has a negative urine pregnancy test result and agrees to take effective contraceptive measures during the test period until 1 year after the infusion.
- The patient or his/her guardian agrees to participate in this clinical trial and signs an informed consent indicating that he/she understands the purpose and procedure of this clinical trial and is willing to participate in the study.
Who cannot join
- Severe major organ involvement related to the primary disease, such as severe pulmonary hypertension (PHA) (mean arterial pressure > 45mmHg).
- primary immunodeficiency or severe secondary immunodeficiency that has not been corrected.
- accompanied by serious or active or uncontrollable infectious diseases, including but not limited to active tuberculosis, latent tuberculosis infection, active viral hepatitis,etc.
- Evidence of active malignant disease or diagnosis of malignant tumor(including hematological malignancies and solid tumors, except resected and cured skin basal cell carcinoma).
- Congenital heart disease or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia,etc.); Or combined with a large number of pericardial effusion, serious myocarditis, etc.;Or patients with unstable vital signs who need hypertensive drugs to maintain their blood pressure.
- suffering from other diseases that require long-term use of glucocorticoids or immunosuppressants.
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- Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months before screening; Acute graft-versushost disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive.
- Had received live vaccine within 4 weeks prior to screening.
- Positive blood pregnancy test.
- Situations in which other investigators consider it inappropriate to participate in the study.
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
Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Meiping Lu, M.D, 13685773988, meipinglu@zju.edu.cn
About this study
Official title: Clinical Study of BCMA/CD70 Targeting Chimeric Antigen Receptor T Lymphocytes(CAR-T) in the Treatment of Refractory Pediatric Rheumatic Diseases
This is an investigator-initiated trial to evaluate the efficacy and safety of BCMA/CD70-targeted CAR-T in the treatment of refractory pediatric rheumatic diseases.
Read the detailed description
Pediatric rheumatic diseases include juvenile dermatomyositis（JDM）, polyarticular juvenile idiopathic arthritis, systemic sclerosis（SSc）, primary Sjogren's syndrome, etc.
Juvenile dermatomyositis (JDM) is a non-suppurative chronic autoimmune disease and the most common type of juvenile idiopathic inflammatory myopathy. Its clinical manifestations include proximal limb muscle weakness and various rashes, which may be accompanied by multiple system involvement such as respiratory, cardiovascular, digestive and nervous systems.Juvenile idiopathic arthritis (JIA) is mainly characterized by chronic synovitis of the joints and also may be accompanied by functional damage to multiple organs. It is an important cause of disability and blindness in childhood. Polyarticular type is a relatively common subtype of JIA, with severe joint symptoms. Systemic sclerosis (SSc) is characterized by thickened and hardened skin and can also affect internal organs. Sjogren's syndrome (SS) is a systemic autoimmune disease that affects exocrine glands. The clinical manifestations of SS in children are mainly recurrent parotitis, parotid gland swelling and systemic symptoms.Despite the active treatment measures, these patients are still intolerant or unresponsive to the treatment, resulting in a high disability and mortality rate.
CAR-T therapy is an adoptive cell therapy that uses genetic modification technology to reprogram T cells and eliminate target cells expressing disease-related antigens through antigen-specific recognition.Since 2019, CAR-T cell therapy has been successfully applied to autoimmune diseases.Many kinds of autoimmune diseases such as systemic lupus erythematosus，systemic sclerosis, idiopathic inflammatory myopathy have good therapeutic effect. These results suggest that CAR-T cells may play a role in several different B-cell-mediated and autoantibody-driven human autoimmune diseases, which is expected to bring breakthroughs in the treatment of refractory pediatric rheumatic diseases.
- Conditions
- Juvenile Dermatomyositis (JDM), Polyarticular Juvenile Idiopathic Arthritis, Systemic Sclerosis (SSc), Primary Sjogren's Syndrome
- Being tested
- BCMA/CD70-targetd CAR-T
- Keywords
- CAR-T, BCMA/CD70
- Medical subject headings
- Dermatomyositis, Arthritis, Juvenile, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMA/CD70-targetd CAR-TBiological
Subjects underwent lymphocytetion cheotherapy and then received a single intravenous cell infusion
| Study group | Role | What they receive |
|---|---|---|
| BCMA/CD70-targeted CAR-T | Experimental | The experiment was divided into two phases: dose exploration (Part A) and dose extension (Part B).In Part A, three dose groups (0.3×10^5/kg, 1×10^5/kg, 3×10^5/kg) are set up, starting from the low dose group to explore the safe and effective dose.Upon the completion of Part A, 1 optimal dose is selected to enter into the Part B stage. The group will then be enrolled in 1~2 cases to continue to validate the safety and efficacy.The enrollment of 4-11 patients is expected in the each indication of the trial. Receives: Biological: BCMA/CD70-targetd CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of CAR-T in the treatment of refractory pediatric rheumatic diseases [Safety and Tolerability]
The incidence of adverse events after CAR-T cell infusion was assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) including the type, frequency and severity of adverse events.
Measured: 28 days
The Total Improvement Score (TIS) of CAR-T in the treatment of refractory juvenile dermatomyositis [Effectiveness]
The proportion of subjects who achieved the minimal, moderate, and major clinical response of the Total Improvement Score (TIS) within 6 months after reinfusion.
Measured: 6 months
Minimal disease activity, inactive disease and remission of CAR-T in the treatment of refractory polyarticular juvenile idiopathic arthritis [Effectiveness]
The proportion of subjects who achieved minimal disease activity, inactive disease and remission within 6 months.
Measured: 6 months
Ped ACR 30/50/70/90/100 of CAR-T in the treatment of refractory polyarticular juvenile idiopathic arthritis [Effectiveness]
The proportion of subjects who achieved Ped ACR 30/50/70/90/100 within 6 months.
Measured: 6 months
mRSS of CAR-T in the treatment of refractory systemic sclerosis [Effectiveness]
The changes from baseline in the modified Rodnan skin score (mRSS) within 6 months.
Measured: 6 months
MDAI of CAR-T in the treatment of refractory systemic sclerosis [Effectiveness]
The changes from baseline in modified disease activity index (MDAI) within 6 months.
Measured: 6 months
EUSTAR activity index of CAR-T in the treatment of refractory systemic sclerosis [Effectiveness]
The changes from baseline in EUSTAR activity index within 6 months.
Measured: 6 months
CRISS of CAR-T in the treatment of refractory systemic sclerosis [Effectiveness]
The changes from baseline in Composite Response Index (CRISS) within 6 months.
Measured: 6 months
Minimal disease activity, inactive disease and remission of CAR-T in the treatment of refractory primary Sjogren's syndrome [Effectiveness]
The proportion of subjects who achieved minimal disease activity, inactive disease and remission within 6 months.
Measured: 6 months
The STAR response rate of CAR-T in the treatment of refractory primary Sjogren's syndrome [Effectiveness]
The proportion of subjects who achieved the STAR response rate within 6 months.
Measured: 6 months
ESSDAI of CAR-T in the treatment of refractory primary Sjogren's syndrome [Effectiveness]
The changes from baseline in ESSDAI within 6 months.
Measured: 6 months
clinESSDAI of CAR-T in the treatment of refractory primary Sjogren's syndrome [Effectiveness]
The changes from baseline in clinESSDAI within 6 months.
Measured: 6 months
ESSPRI of CAR-T in the treatment of refractory primary Sjogren's syndrome [Effectiveness]
The changes from baseline in ESSPRI within 6 months.
Measured: 6 months
Secondary outcomes (5)
Cmax of BCMA/CD70 CAR-T cells [PK parameter]
The Peak Plasma concentration (Cmax) of amplified BCMA/CD70 CAR-T cells in peripheral blood after reinfusion.
Measured: 3 months
Tmax of BCMA/CD70 CAR-T cells [PK parameter]
The time of amplified BCMA/CD70 CAR-T cells in peripheral blood to reach the maximum concentration (Tmax).
Measured: 3 months
AUC28d/90d of BCMA/CD70 CAR-T cells [PK parameter]
The area under the plasma concentration versus time curve at 28 days /90 days after reinfusion (AUC28d/90d).
Measured: 3 months
The clearance degree of B cells [PD parameter]
The clearance degree of B cells at each time point.
Measured: 3 months
CAR-T-related serum cytokines [PD parameter]
The concentration levels of CAR-T-related serum cytokines such as IL-6.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Sep 2025
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Dermatomyositis (JDM)Studies of the same condition, open and under way.
- More trials run by Chongqing Precision Biotech Co., LtdThe sponsor's other registered studies.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Precision Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184450
- Sponsor's protocol ID
- PBC103
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 19 Sep 2025
- 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 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of BCMA/CD70 Targeting Chimeric Antigen Receptor T Lymphocytes(CAR-T) in the Treatment of Refractory Pediatric Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT07184450
- Acronym / sponsor ID
- PBC103
- Conditions
- Juvenile Dermatomyositis (JDM), Polyarticular Juvenile Idiopathic Arthritis, Systemic Sclerosis (SSc), Primary Sjogren's Syndrome
- Keywords
- CAR-T, BCMA/CD70
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Chongqing Precision Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 19 Sep 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.
This is an investigator-initiated trial to evaluate the efficacy and safety of BCMA/CD70-targeted CAR-T in the treatment of refractory pediatric rheumatic diseases.
Detailed description
Pediatric rheumatic diseases include juvenile dermatomyositis（JDM）, polyarticular juvenile idiopathic arthritis, systemic sclerosis（SSc）, primary Sjogren's syndrome, etc.
Juvenile dermatomyositis (JDM) is a non-suppurative chronic autoimmune disease and the most common type of juvenile idiopathic inflammatory myopathy. Its clinical manifestations include proximal limb muscle weakness and various rashes, which may be accompanied by multiple system involvement such as respiratory, cardiovascular, digestive and nervous systems.Juvenile idiopathic arthritis (JIA) is mainly characterized by chronic synovitis of the joints and also may be accompanied by functional damage to multiple organs. It is an important cause of disability and blindness in childhood. Polyarticular type is a relatively common subtype of JIA, with severe joint symptoms. Systemic sclerosis (SSc) is characterized by thickened and hardened skin and can also affect internal organs. Sjogren's syndrome (SS) is a systemic autoimmune disease that affects exocrine glands. The clinical manifestations of SS in children are mainly recurrent parotitis, parotid gland swelling and systemic symptoms.Despite the active treatment measures, these patients are still intolerant or unresponsive to the treatment, resulting in a high disability and mortality rate.
CAR-T therapy is an adoptive cell therapy that uses genetic modification technology to reprogram T cells and eliminate target cells expressing disease-related antigens through antigen-specific recognition.Since 2019, CAR-T cell therapy has been successfully applied to autoimmune diseases.Many kinds of autoimmune diseases such as systemic lupus erythematosus，systemic sclerosis, idiopathic inflammatory myopathy have good therapeutic effect. These results suggest that CAR-T cells may play a role in several different B-cell-mediated and autoantibody-driven human autoimmune diseases, which is expected to bring breakthroughs in the treatment of refractory pediatric rheumatic diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCMA/CD70-targeted CAR-T | Experimental | Biological: BCMA/CD70-targetd CAR-TThe experiment was divided into two phases: dose exploration (Part A) and dose extension (Part B).In Part A, three dose groups (0.3×10^5/kg, 1×10^5/kg, 3×10^5/kg) are set up, starting from the low dose group to explore the safe and effective dose.Upon the completion of Part A, 1 optimal dose is selected to enter into the Part B stage. The group will then be enrolled in 1~2 cases to continue to validate the safety and efficacy.The enrollment of 4-11 patients is expected in the each indication of the trial. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (23 listed)
- Age ≥5 years old.
- To meet the diagnostic criteria of refractory B-cell-related pediatric rheumatic diseases, including but not limited to juvenile dermatomyositis, polyarticular juvenile idiopathic arthritis, systemic sclerosis, and primary Sjogren's syndrome.
- Positive expression of CD19 in peripheral blood B cells determined by flow cytometry, and B cells > 5 per/uL.
- Previously not treated with CAR-T; or recurrence or poor efficacy after previous autologous or universal CD19-targeted CAR-T treatment (evaluated by the researcher).
- The functions of important organs are basically normal:
Key exclusion criteria (11 listed)
- Severe major organ involvement related to the primary disease, such as severe pulmonary hypertension (PHA) (mean arterial pressure > 45mmHg).
- primary immunodeficiency or severe secondary immunodeficiency that has not been corrected.
- accompanied by serious or active or uncontrollable infectious diseases, including but not limited to active tuberculosis, latent tuberculosis infection, active viral hepatitis,etc.
- Evidence of active malignant disease or diagnosis of malignant tumor(including hematological malignancies and solid tumors, except resected and cured skin basal cell carcinoma).
- Congenital heart disease or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia,etc.); Or combined with a large number of pericardial effusion, serious myocarditis, etc.;Or patients with unstable vital signs who need hypertensive drugs to maintain their blood pressure.
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 |
|---|---|---|
| BCMA/CD70-targetd CAR-TSubjects underwent lymphocytetion cheotherapy and then received a single intravenous cell infusion | Biological | BCMA/CD70-targeted CAR-T |
Primary outcome
To evaluate the safety of CAR-T in the treatment of refractory pediatric rheumatic diseases [Safety and Tolerability]
Time frame: 28 days
The incidence of adverse events after CAR-T cell infusion was assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) including the type, frequency and severity of adverse events.
The Total Improvement Score (TIS) of CAR-T in the treatment of refractory juvenile dermatomyositis [Effectiveness]
Time frame: 6 months
The proportion of subjects who achieved the minimal, moderate, and major clinical response of the Total Improvement Score (TIS) within 6 months after reinfusion.
Minimal disease activity, inactive disease and remission of CAR-T in the treatment of refractory polyarticular juvenile idiopathic arthritis [Effectiveness]
Time frame: 6 months
The proportion of subjects who achieved minimal disease activity, inactive disease and remission within 6 months.
Ped ACR 30/50/70/90/100 of CAR-T in the treatment of refractory polyarticular juvenile idiopathic arthritis [Effectiveness]
Time frame: 6 months
The proportion of subjects who achieved Ped ACR 30/50/70/90/100 within 6 months.
mRSS of CAR-T in the treatment of refractory systemic sclerosis [Effectiveness]
Time frame: 6 months
The changes from baseline in the modified Rodnan skin score (mRSS) within 6 months.
MDAI of CAR-T in the treatment of refractory systemic sclerosis [Effectiveness]
Time frame: 6 months
The changes from baseline in modified disease activity index (MDAI) within 6 months.
EUSTAR activity index of CAR-T in the treatment of refractory systemic sclerosis [Effectiveness]
Time frame: 6 months
The changes from baseline in EUSTAR activity index within 6 months.
CRISS of CAR-T in the treatment of refractory systemic sclerosis [Effectiveness]
Time frame: 6 months
The changes from baseline in Composite Response Index (CRISS) within 6 months.
Minimal disease activity, inactive disease and remission of CAR-T in the treatment of refractory primary Sjogren's syndrome [Effectiveness]
Time frame: 6 months
The proportion of subjects who achieved minimal disease activity, inactive disease and remission within 6 months.
The STAR response rate of CAR-T in the treatment of refractory primary Sjogren's syndrome [Effectiveness]
Time frame: 6 months
The proportion of subjects who achieved the STAR response rate within 6 months.
ESSDAI of CAR-T in the treatment of refractory primary Sjogren's syndrome [Effectiveness]
Time frame: 6 months
The changes from baseline in ESSDAI within 6 months.
clinESSDAI of CAR-T in the treatment of refractory primary Sjogren's syndrome [Effectiveness]
Time frame: 6 months
The changes from baseline in clinESSDAI within 6 months.
ESSPRI of CAR-T in the treatment of refractory primary Sjogren's syndrome [Effectiveness]
Time frame: 6 months
The changes from baseline in ESSPRI within 6 months.
5 secondary outcomes
Cmax of BCMA/CD70 CAR-T cells [PK parameter]
Time frame: 3 months
Tmax of BCMA/CD70 CAR-T cells [PK parameter]
Time frame: 3 months
AUC28d/90d of BCMA/CD70 CAR-T cells [PK parameter]
Time frame: 3 months
The clearance degree of B cells [PD parameter]
Time frame: 3 months
CAR-T-related serum cytokines [PD parameter]
Time frame: 3 months
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 19 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BCMA/CD70-targetd CAR-T in people with Juvenile Dermatomyositis (JDM) and Polyarticular Juvenile Idiopathic Arthritis, run by Chongqing Precision 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 23 inclusion and 11 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 19 Sep 2025. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Meiping Lu, M.D (13685773988, meipinglu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of CAR-T in the treatment of refractory pediatric rheumatic diseases [Safety and Tolerability] (time frame: 28 days). The study lists 13 primary outcomes in all. 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 19 Sep 2025.