Systemic Lupus ErthematosusPhase 1/2NCT06828042
Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells in Refractory Autoimmune Diseases
A Phase 1/2 study testing anti-CD19 CAR T cell therapy in people with Systemic Lupus Erthematosus and Systemic Sclerosis (SSc), run by Peking University Third Hospital at 1 site in China.
Trial summary
Autoimmune diseases refer to a common category of diseases caused by the immune system reacting to self-antigens, leading to tissue damage. Autoimmune diseases encompass a wide variety of conditions, such as systemic lupus erythematosus（SLE）, Sjögren's syndrome (SS), systemic sclerosis (SSc), inflammatory myopathies… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Systemic Lupus Erthematosus, Systemic Sclerosis (SSc), Sjogren Syndrome
- What is being tested?
- anti-CD19 CAR T cell therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Dec 2027
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Common Inclusion Criteria:
- Age between 18-80 years (inclusive), male or female.
- Positive expression of CD19 on peripheral blood B cells by flow cytometry.
- Diagnosed with refractory autoimmune disease, defined as: Ineffectiveness of conventional treatment for more than 6 months, or Disease activity recurrence after remission. Definition of conventional treatment: Use of glucocorticoids and any of the following immunosuppressants or biologics: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, rituximab, belimumab, telitacicept, etc.
- Currently receiving one or more standard therapies at a stable dose, including glucocorticoids, antimalarials, immunosuppressants, or biologics. If the subject is receiving glucocorticoids, the following conditions must be met: During screening and the screening period, the maximum dose of glucocorticoids is 30 mg/day prednisone (or an equivalent dose). The glucocorticoid dose must remain stable for ≥7 days before screening, and during the screening period, the dose adjustment must not exceed >5 mg/day prednisone (or an equivalent dose). If the subject is receiving antimalarials and/or conventional immunosuppressants: The treatment must have started ≥12 weeks before screening. The medication dose must remain stable for ≥8 weeks before screening and throughout the screening period. Before cell infusion, other immunosuppressants (excluding hydroxychloroquine), including belimumab, telitacicept, CD20 monoclonal antibodies, or other biologic immunosuppressants, must be discontinued for at least 5 half-lives.
- Female participants of childbearing potential and male participants with female partners of childbearing potential must use medically approved contraceptive methods or practice abstinence during the study treatment period and for at least 6 months after the study. Female participants of childbearing potential must have a negative serum HCG test within 7 days before enrollment and must not be breastfeeding.
Show all 34Show fewer
- Willing to participate in the trial and sign the informed consent form.
- Disease-Specific Inclusion Criteria:
- Systemic Lupus Erythematosus (SLE):
- Meets the 2019 EULAR/ACR classification criteria for SLE.
- ANA titer ≥1:80, or positive for anti-dsDNA and/or anti-Sm antibodies.
- Disease activity score (SLEDAI-2000) ≥8.
- Sjögren's Syndrome:
- Meets the 2002 AECG criteria or the 2016 ACR/EULAR classification criteria for primary Sjögren's syndrome.
- Disease activity score (ESSDAI) ≥5.
- Positive for anti-SSA/Ro antibodies.
- Systemic Sclerosis (SSc):
- Meets the 2013 EULAR/ACR classification criteria for systemic sclerosis.
- Classified by Leroy and Medsger as limited or diffuse cutaneous subsets.
- At screening, mRSS >10; and/or active interstitial lung disease (ILD), defined as: High-resolution computed tomography (HRCT) showing ground-glass opacities. Pulmonary function tests (FVC or DLCO) <70% of predicted values.
- Idiopathic Inflammatory Myopathies (IIM):
- Meets the 2017 EULAR/ACR classification criteria for inflammatory myopathies (including dermatomyositis, polymyositis, antisynthetase syndrome, and necrotizing myopathy).
- For patients with muscle involvement: a. MMT-8 score <142 and at least two abnormal findings among the following core measures: PhGA or PtGA scores ≥2. Extramuscular disease activity score ≥2. HAQ total score ≥0.25. Muscle enzyme levels ≥1.5 times the upper normal limit. b. Alternatively, MMT-8 ≥142 but with active ILD (HRCT showing ground-glass opacities).
- Positive for myositis-specific antibodies.
- ANCA-Associated Vasculitis (AAV):
- Meets the 2022 ACR/EULAR diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, or eosinophilic granulomatosis with polyangiitis.
- Positive for ANCA antibodies (current or historical).
- Birmingham Vasculitis Activity Score (BVAS) ≥15 (out of 63), indicating active vasculitis.
- Refractory Antiphospholipid Syndrome (APS):
- Meets the 2023 ACR/EULAR diagnostic criteria for antiphospholipid syndrome.
- Positive for medium-to-high titers of antiphospholipid antibodies (LA, anti-β2-GP1, or ACL IgG/IgM), with at least two positive results within 3 months.
- Definition of refractory APS: Disease remains active or relapses after remission, despite 6 months of conventional therapy, including: Anticoagulants (warfarin or standard treatment with vitamin K antagonists maintaining target INR) or low-molecular-weight heparin at standard doses. Glucocorticoids and/or immunosuppressants.
- Catastrophic APS (CAPS): Must meet all four criteria: a. Involvement of three or more organs, systems, and/or tissues. b. Symptoms occurring within one week. c. Histological evidence of small vessel occlusion in at least one organ or tissue. d. Positive for antiphospholipid antibodies (aPL).
- Note: Meeting either criterion 3 or 4 is sufficient. Patients with thrombocytopenia may not require anticoagulant therapy.
Who cannot join
- History of severe drug allergies or allergic constitution.
- Presence or suspicion of uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.
- Central nervous system (CNS) diseases caused by autoimmune or non-autoimmune conditions, including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accidents, encephalitis, or CNS vasculitis.
- Dysfunction of major organs not meeting the following criteria (exceptions allowed if abnormalities are caused by autoimmune disease): a. Bone marrow function: White blood cell count ≥3×10⁹/L. Neutrophil count ≥1×10⁹/L (without GSF treatment within 2 weeks prior to testing). Hemoglobin ≥60 g/L. Platelet count ≥50×10⁹/L. b. Liver function: ALT ≤3×ULN (exceptions for ALT elevation caused by inflammatory myopathy). AST ≤3×ULN (exceptions for AST elevation caused by inflammatory myopathy). IBIL ≤1.5×ULN (exceptions for Gilbert's syndrome). Total bilirubin ≤3.0×ULN. c. Renal function: Creatinine clearance (CrCl) ≥30 mL/min (calculated using the Cockcroft/Gault formula, exceptions for acute CrCl decline caused by the disease itself). d. Coagulation function: International normalized ratio (INR) ≤1.5×ULN. Prothrombin time (PT) ≤1.5×ULN. e. Cardiac function: Stable hemodynamics.
- Subjects with congenital immunoglobulin deficiencies.
- History of malignancy within the past five years.
Show all 12Show fewer
- Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA levels exceeding the detection limit; positive hepatitis C virus (HCV) antibodies with detectable HCV RNA in peripheral blood; positive HIV antibodies; or positive syphilis test results.
- Subjects with psychiatric disorders or severe cognitive impairment.
- Participation in other clinical trials within 3 months prior to enrollment.
- Previous treatment with CAR-T therapy.
- History of severe adverse reactions to cyclophosphamide or fludarabine.
- Any other reason that the investigator determine that subjects cannot be included in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xiaoying Zhang contact
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Xiaoying Zhang, 86+13810001444, zhang_xiaoying@pku.edu.cn
Xiaoying Zhang
About this study
Official title: A Single-center Clinical Study Evaluating the Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells（QH103） in Refractory Autoimmune Diseases
Autoimmune diseases refer to a common category of diseases caused by the immune system reacting to self-antigens, leading to tissue damage. Autoimmune diseases encompass a wide variety of conditions, such as systemic lupus erythematosus（SLE）, Sjögren's syndrome (SS), systemic sclerosis (SSc), inflammatory myopathies (IM), ANCA-associated vasculitis (AAV), and antiphospholipid syndrome (APS). They affect the quality of life, while in severe cases, they can be life-threatening. Additionally, they impose a heavy economic burden on society. Current treatments for autoimmune diseases include glucocorticoid, immunosuppressants, and biologics. B cell-driven humoral immune abnormalities are a central pathogenic mechanism in many autoimmune diseases. When autoreactive B cells are excessively activated, they produce large amounts of autoantibodies and immune complexes. These antibodies and immune complexes can cause damage to various tissues and organs, leading to the development of multiple autoimmune diseases. Therefore, targeting B cells to treat autoimmune diseases is an attractive therapeutic strategy.
Chimeric Antigen Receptor (CAR)-T cells targeting the B cell surface molecule CD19 have achieved significant clinical progress in acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma, with several CD19 CAR-T therapies approved for marketing worldwide. Increasingly, clinical studies are exploring the use of CD19 CAR-T cells for the treatment of autoimmune diseases, and their therapeutic efficacy has been demonstrated.
In this study, the investigators used γδ T cells as carrier cells to investigate the safety and efficacy of universal CAR-γδ T cells in the treatment of autoimmune diseases.
- Conditions
- Systemic Lupus Erthematosus, Systemic Sclerosis (SSc), Sjogren Syndrome, ANCA Associated Vasculitis (AAV), Inflammatory Myopathies, Antiphospholipid Syndrome
- Being tested
- anti-CD19 CAR T cell therapy
- Medical subject headings
- Scleroderma, Systemic, Sjogren's Syndrome, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Myositis, Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD19 CAR T cell therapyBiological
anti-CD19 CAR-γδ T cell therapy
| Study group | Role | What they receive |
|---|---|---|
| anti-CD19 CAR-γδ T | Experimental | Not described Receives: Biological: anti-CD19 CAR T cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of QH103（anti-CD19 CAR-γδT cells）
Incidence of Treatment-Emergent Adverse Events (AEs) in this study. AEs are defined as any adverse medical events occurring from the initiation of lymphodepleting chemotherapy to 12 months after the completion of QH103 cell infusion. The incidence, duration, severity, and management of all adverse events occurring after the participants' enrollment will be recorded and evaluated.Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) criteria. Graft-versus-host disease (GVHD) will be graded based on the criteria defined by the Mount Sinai Acute GVHD International Consortium. Other AEs will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v5.0).
Measured: 0-Month 12
Maximum tolerated dose of CD19 CAR-γδT cells
Dose-limiting toxicity after cell infusion
Measured: 28 days
Secondary outcomes (17)
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2000) score
The change from baseline in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2000) score at Month 3, 6, 9, and 12.
Measured: Month 3, 6, 9, and 12
SRI-4 response
SLE patients who met all three of the following conditions at month3,6,9, and 12 after infusion, achieve SRI-4 response:
- The SLEDAI-2K rating dropped by at least 4 points
- No deterioration in PGA scores on a 3-point scale (deterioration is defined as an increase of ≥0.3 points from baseline score)
- No new manifestations of organ system involvement (new system involvement is defined as one or more new symptoms of BILAG grade A or two or more symptoms of BILAG B)
Measured: month 3, 6, 9, and 12
Sjögren's Tool for Assessing Response (STAR) score
The changes from baseline in the Sjögren's Tool for Assessing Response (STAR) score at Month 3, 6, 9, and 12.
Measured: Month 3, 6, 9, and 12.
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)
The changes from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at Month 3, 6, 9, and 12.
Measured: Month 3, 6, 9, and 12
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
The changes from baseline in the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) at Month 3, 6, 9, and 12.
Measured: Month 3, 6, 9, and 12
Systemic Sclerosis Combined Response Index (CRISS) response
Patients achieve Systemic Sclerosis Combined Response Index (CRISS) response Month 3, 6, 9, and 12. A responder meets all of the following criteria; otherwise, they are classified as a non-responder.
- Improvement in at least two aspects (≥ 5% increase in ppFVC and/or ≥ 25% decrease in mRSS, HAQ-DI, PtGA, or PhGA);
- Worsening in no more than one aspect (≥ 5% decrease in ppFVC and/or ≥ 25% increase in mRSS, HAQ-DI, PtGA, or PhGA);
- No significant new SSc-related manifestations.
Measured: Month 3, 6, 9, and 12
Modified Rodnan Skin Score (mRSS)
The changes from baseline in the modified Rodnan Skin Score (mRSS) at Month 3, 6, 9, and 12.
Measured: Month 3, 6, 9, and 12
Total Improvement Score (TIS)
For IM patients with a baseline MMT-8 score <142, the changes from baseline in Total Improvement Score (TIS) based on the Myositis Response Criteria, which includes changes in the physician's global assessment, the patient's global assessment, the health assessment questionnaire (SF-36), manual muscle testing (MMT-8), muscle enzymes, and extramuscular disease activity at month 3, 6, 9, and 12.
Measured: Month 3, 6, 9, and 12
Improvement in interstitial lung disease
For IM patients with a baseline MMT-8 score ≥142, the assessment of improvement in interstitial lung disease, defined as an increase of ≥10% in forced vital capacity (FVC) or diffusing capacity for carbon monoxide (DLCO) compared to baseline at Month 3, 6, 9, and 12.
Measured: Month 3, 6, 9, and 12
Vasculitis disease activity assessment (BVAS score)
The changes from baseline in vasculitis disease activity assessment (BVAS score) for patients with AAV at Month 3, 6, 9, and 12
Measured: Month 3, 6, 9, and 12
Vasculitis Damage Index (VDI)
The changes from baseline in the Vasculitis Damage Index (VDI) for AAV patients at Month 3, 6, 9, and 12.
Measured: Month 3, 6, 9, and 12
Newly developed, imaging-confirmed thrombosis in APS patients
Newly developed, imaging-confirmed thrombosis in APS patients at Month 3, 6, 9, and 12.
Measured: Month 3, 6, 9, and 12
Platelet count for APS patients
The changes from baseline in platelet count for APS patients at Month 3, 6, 9, and 12.
Measured: Month 3, 6, 9, and 12
PD parameters
The Changes from baseline of level IL-6 in peripheral blood after infusion of QH103
Measured: 0-Month 3
PK-Tmax
Time to peak in CAR-T cell count in peripheral blood after infusion of QH103.
Measured: 0-Month 3
PK-Cmax
Peak concentration (Cmax) in the CAR-T cell count in peripheral blood after infusion of QH103
Measured: 0-Month 3
PK-AUC
Area under the concentration-time curve of CAR-T cell count in peripheral blood after infusion of QH103 from 0 to 3 months
Measured: 0-Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErthematosusStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828042
- Sponsor's protocol ID
- M20250025
- Status last verified
- Apr 2026
- First submitted
- 4 Feb 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No decision has been made regarding the issue
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Clinical Study Evaluating the Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells（QH103） in Refractory Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT06828042
- Acronym / sponsor ID
- M20250025
- Conditions
- Systemic Lupus Erthematosus, Systemic Sclerosis (SSc), Sjogren Syndrome, ANCA Associated Vasculitis (AAV), Inflammatory Myopathies, Antiphospholipid Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Feb 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.
Autoimmune diseases refer to a common category of diseases caused by the immune system reacting to self-antigens, leading to tissue damage. Autoimmune diseases encompass a wide variety of conditions, such as systemic lupus erythematosus（SLE）, Sjögren's syndrome (SS), systemic sclerosis (SSc), inflammatory myopathies (IM), ANCA-associated vasculitis (AAV), and antiphospholipid syndrome (APS). They affect the quality of life, while in severe cases, they can be life-threatening. Additionally, they impose a heavy economic burden on society. Current treatments for autoimmune diseases include glucocorticoid, immunosuppressants, and biologics. B cell-driven humoral immune abnormalities are a central pathogenic mechanism in many autoimmune diseases. When autoreactive B cells are excessively activated, they produce large amounts of autoantibodies and immune complexes. These antibodies and immune complexes can cause damage to various tissues and organs, leading to the development of multiple autoimmune diseases. Therefore, targeting B cells to treat autoimmune diseases is an attractive therapeutic strategy.
Chimeric Antigen Receptor (CAR)-T cells targeting the B cell surface molecule CD19 have achieved significant clinical progress in acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma, with several CD19 CAR-T therapies approved for marketing worldwide. Increasingly, clinical studies are exploring the use of CD19 CAR-T cells for the treatment of autoimmune diseases, and their therapeutic efficacy has been demonstrated.
In this study, the investigators used γδ T cells as carrier cells to investigate the safety and efficacy of universal CAR-γδ T cells in the treatment of autoimmune diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-CD19 CAR-γδ T | Experimental | Biological: anti-CD19 CAR T cell therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Age between 18-80 years (inclusive), male or female.
- Positive expression of CD19 on peripheral blood B cells by flow cytometry.
- Diagnosed with refractory autoimmune disease, defined as: Ineffectiveness of conventional treatment for more than 6 months, or Disease activity recurrence after remission. Definition of conventional treatment: Use of glucocorticoids and any of the following immunosuppressants or biologics: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, rituximab, belimumab, telitacicept, etc.
- Currently receiving one or more standard therapies at a stable dose, including glucocorticoids, antimalarials, immunosuppressants, or biologics. If the subject is receiving glucocorticoids, the following conditions must be met: During screening and the screening period, the maximum dose of glucocorticoids is 30 mg/day prednisone (or an equivalent dose). The glucocorticoid dose must remain stable for ≥7 days before screening, and during the screening period, the dose adjustment must not exceed >5 mg/day prednisone (or an equivalent dose). If the subject is receiving antimalarials and/or conventional immunosuppressants: The treatment must have started ≥12 weeks before screening. The medication dose must remain stable for ≥8 weeks before screening and throughout the screening period. Before cell infusion, other immunosuppressants (excluding hydroxychloroquine), including belimumab, telitacicept, CD20 monoclonal antibodies, or other biologic immunosuppressants, must be discontinued for at least 5 half-lives.
- Female participants of childbearing potential and male participants with female partners of childbearing potential must use medically approved contraceptive methods or practice abstinence during the study treatment period and for at least 6 months after the study. Female participants of childbearing potential must have a negative serum HCG test within 7 days before enrollment and must not be breastfeeding.
Key exclusion criteria (12 listed)
- History of severe drug allergies or allergic constitution.
- Presence or suspicion of uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.
- Central nervous system (CNS) diseases caused by autoimmune or non-autoimmune conditions, including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accidents, encephalitis, or CNS vasculitis.
- Dysfunction of major organs not meeting the following criteria (exceptions allowed if abnormalities are caused by autoimmune disease): a. Bone marrow function: White blood cell count ≥3×10⁹/L. Neutrophil count ≥1×10⁹/L (without GSF treatment within 2 weeks prior to testing). Hemoglobin ≥60 g/L. Platelet count ≥50×10⁹/L. b. Liver function: ALT ≤3×ULN (exceptions for ALT elevation caused by inflammatory myopathy). AST ≤3×ULN (exceptions for AST elevation caused by inflammatory myopathy). IBIL ≤1.5×ULN (exceptions for Gilbert's syndrome). Total bilirubin ≤3.0×ULN. c. Renal function: Creatinine clearance (CrCl) ≥30 mL/min (calculated using the Cockcroft/Gault formula, exceptions for acute CrCl decline caused by the disease itself). d. Coagulation function: International normalized ratio (INR) ≤1.5×ULN. Prothrombin time (PT) ≤1.5×ULN. e. Cardiac function: Stable hemodynamics.
- Subjects with congenital immunoglobulin deficiencies.
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 |
|---|---|---|
| anti-CD19 CAR T cell therapyanti-CD19 CAR-γδ T cell therapy | Biological | anti-CD19 CAR-γδ T |
Primary outcome
Safety of QH103（anti-CD19 CAR-γδT cells）
Time frame: 0-Month 12
Incidence of Treatment-Emergent Adverse Events (AEs) in this study. AEs are defined as any adverse medical events occurring from the initiation of lymphodepleting chemotherapy to 12 months after the completion of QH103 cell infusion. The incidence, duration, severity, and management of all adverse events occurring after the participants' enrollment will be recorded and evaluated.Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) criteria. Graft-versus-host disease (GVHD) will be graded based on the criteria defined by the Mount Sinai Acute GVHD International Consortium. Other AEs will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v5.0).
Maximum tolerated dose of CD19 CAR-γδT cells
Time frame: 28 days
Dose-limiting toxicity after cell infusion
17 secondary outcomes
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2000) score
Time frame: Month 3, 6, 9, and 12
SRI-4 response
Time frame: month 3, 6, 9, and 12
Sjögren's Tool for Assessing Response (STAR) score
Time frame: Month 3, 6, 9, and 12.
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)
Time frame: Month 3, 6, 9, and 12
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
Time frame: Month 3, 6, 9, and 12
Systemic Sclerosis Combined Response Index (CRISS) response
Time frame: Month 3, 6, 9, and 12
Modified Rodnan Skin Score (mRSS)
Time frame: Month 3, 6, 9, and 12
Total Improvement Score (TIS)
Time frame: Month 3, 6, 9, and 12
Improvement in interstitial lung disease
Time frame: Month 3, 6, 9, and 12
Vasculitis disease activity assessment (BVAS score)
Time frame: Month 3, 6, 9, and 12
Vasculitis Damage Index (VDI)
Time frame: Month 3, 6, 9, and 12
Newly developed, imaging-confirmed thrombosis in APS patients
Time frame: Month 3, 6, 9, and 12
Platelet count for APS patients
Time frame: Month 3, 6, 9, and 12
PD parameters
Time frame: 0-Month 3
PK-Tmax
Time frame: 0-Month 3
PK-Cmax
Time frame: 0-Month 3
PK-AUC
Time frame: 0-Month 3
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 22 Sep 2026.
- Individual participant dataSharing planned: Undecided. No decision has been made regarding the issue
Related trials for Systemic Lupus Erthematosus
Recruiting
Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous
Systemic Lupus Erthematosus (SLE)
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
RecruitingPhase 1/2
A Phase 1b/2a Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erthematosus
Not yet recruiting
Home-Based High-Intensity Interval Training in Systemic Lupus Erythematosus
Systemic Lupus Erthematosus, Fatigue
Not yet recruitingPhase 1/2
Safety and Efficacy of Universal CAR-T Cells (UWD-CD19) Combined With Immunosuppressants in the Treatment of Refractory Autoimmune Diseases
Systemic Lupus Erthematosus, Systemic Sclerosis (SSc)
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.
Xiaoying Zhang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing anti-CD19 CAR T cell therapy in people with Systemic Lupus Erthematosus and Systemic Sclerosis (SSc), run by Peking University Third Hospital 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 34 inclusion and 12 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 22 Sep 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xiaoying Zhang (86+13810001444, zhang_xiaoying@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of QH103（anti-CD19 CAR-γδT cells） (time frame: 0-Month 12). The study lists 2 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 22 Sep 2026.