Refractory/Relapsed Systemic Lupus ErythematosusPhase 1NCT07490275
Allogeneic CD19/BCMA-Targeted CAR-γδT Cell Therapy: Safety and Preliminary Pharmacodynamics in Relapsed/Refractory Autoimmune Diseases
A Phase 1 study testing Allogeneic CD19/BCMA-targeted CAR-γδT cell injection, Cyclophosphamide and Fludarabine in people with Refractory/Relapsed Systemic Lupus Erythematosus and Refractory / Relapsed / Progressive Systemic Sclerosis, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This study is a single-arm, intervention, dose-escalation clinical trial to evaluate the safety of allogeneic CD19/BCMA-targeted CAR-γδT cell in the treatment of relapsed/refractory autoimmune diseases Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory/Relapsed Systemic Lupus Erythematosus, Refractory / Relapsed / Progressive Systemic Sclerosis, Refractory / Relapsing / Progressive Inflammatory Myopathy
- What is being tested?
- Allogeneic CD19/BCMA-targeted CAR-γδT cell injection, Cyclophosphamide and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years (including 18 years), no gender restrictions.
- Confirmed by flow cytometry to express CD19 or BCMA antigen on the surface of peripheral blood B cells.
- Major organ function must meet the following requirements (excluding abnormalities related to active autoimmune disease):
- Bone marrow function: Neutrophil count ≥ 1 × 10^9/L (no colony-stimulating factor therapy within 2 weeks prior to testing); Haemoglobin ≥ 60 g/L.
- Liver function: Alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN) (excluding ALT elevation due to inflammatory myopathy) ; Aspartate Aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy); Total Bilirubin (TBIL) ≤ 2 times ULN (may be relaxed to ≤ 3.0 times ULN for subjects with Gilbert's syndrome).
- Renal function: Creatinine clearance (CrCl) ≥ 30 ml/min (calculated using the Cockcroft-Gault formula, excluding acute CrCl decline due to target disease; lupus nephritis (LN) patients excluded).
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- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstain from sexual intercourse for at least 6 months during study treatment and for at least 6 months after study treatment completion.
- Voluntary participation in this clinical study, signing of informed consent, good compliance, and ability to complete follow-up.
- Disease-specific inclusion criteria:
- Relapsed/refractory systemic lupus erythematosus
- Diagnosis of systemic lupus erythematosus (SLE) meeting the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria.
- Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2000) ≥ 8 points; or significant organ involvement, such as lupus nephritis (histologically confirmed active nephritis of type III or IV, with or without type V involvement; National Institutes of Health [NIH] activity score > 2 points; evidence of elevated chronicity index; urine protein/creatinine ratio > 1.0 g/g, or 24-hour urine protein quantification > 1.0 g).
- Refractory or recurrent disease is defined as: no response after more than 6 months of conventional therapy, or recurrence of disease activity following remission. Conventional therapy is defined as: glucocorticoids combined with one or more of the following immunomodulatory agents: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as rituximab, belimumab, or tatalimab.
- Refractory/Recurrent/Progressive Systemic Sclerosis
- Scleroderma diagnosis conforms to the 2013 ACR（American College of Rheumatology） classification criteria.
- Positive for scleroderma-associated antibodies.
- Presence of diffuse cutaneous sclerosis or active interstitial lung disease (high-resolution computed tomography (HRCT) showing ground-glass opacities).
- Definition of recurrent/refractory: No response to conventional therapy for over 6 months, or recurrence following remission. Conventional therapy defined as: Glucocorticoids combined with any one or more of the following immunomodulators: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as belimumab, rituximab, or tocilizumab.
- Progressive definition: Rapid progression of cutaneous lesions (Modified Rodnan Skin Score (mRSS) increase > 25%); or progression of pulmonary lesions (Forced Vital Capacity (FVC) decline ≥10%, or FVC decline ≥5% accompanied by Diffusion Capacity for Carbon Monoxide (DLCO) decline ≥15%).
- Note: Fulfilment of either criterion 4 or 5 is sufficient.
- Refractory/Recurrent/Progressive Inflammatory Myopathies
- Diagnosis of inflammatory myopathy conforms to the 2017 EULAR（European Alliance of Associations for Rheumatology）/ACR classification criteria (including dermatomyositis (DM), polymyositis (PM), anti-synthetase syndrome (ASS), and necrotising myopathy (NM)).
- Muscle involvement present, Manual Muscle Test - 8 (MMT-8) score < 142 points, and at least 2 abnormalities in the following 5 core indicators: Physician Global Assessment (PhGA), Patient Global Assessment (PtGA) or extra-muscular disease activity score ≥ 2 points; Health Assessment Questionnaire (HAQ) total score ≥ 0.25 points; Muscle enzyme levels ≥1.5 times the upper limit of normal.
- Definition of recurrent/refractory: No response to conventional therapy for over 6 months, or relapse following remission. Conventional therapy defined as: Glucocorticoids combined with any one or more of the following immunomodulators: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as belimumab, rituximab, or tocilizumab.
- Definition of progressive disease: Rapid progression of interstitial lung disease within a short timeframe.
- Note: Meeting any one criterion from either section 4 or 5 suffices.
- Refractory/Recurrent Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
- Diagnosis of ANCA-associated vasculitis conforms to the 2022 ACR/EULAR criteria, encompassing microscopic polyangiitis, granulomatous polyangiitis, and eosinophilic granulomatous polyangiitis.
- ANCA-associated antibody testing is positive (myeloperoxidase antibody [MPO-ANCA] or proteinase 3 antibody [PR3-ANCA] positive).
- Birmingham Vasculitis Activity Score (BVAS) ≥15 points (out of 63 total points), indicating active vasculitis.
- Refractory/recurrent definition: Failure to respond to conventional therapy for over 6 months, or recurrence following remission. Conventional therapy is defined as:Use of glucocorticoids in combination with any one or more of the following immunomodulatory agents: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as belimumab, rituximab, or tocilizumab.
- Refractory/Recurrent Connective Tissue Disease-Associated Thrombocytopenia
- Diagnosis of connective tissue disease conforming to the latest classification criteria, including but not limited to systemic lupus erythematosus, primary Sjögren's syndrome, antiphospholipid syndrome, and undifferentiated connective tissue disease.
- Diagnosed with connective tissue disease-associated thrombocytopenia, with platelet count < 30 × 10⁹/L, or platelet count < 50 × 10⁹/L accompanied by bleeding tendency.
- Bone marrow morphology consistent with features of immune thrombocytopenia.
- Previous treatment with at least one course of glucocorticoid pulse therapy, or high-dose glucocorticoids combined with one or more immunosuppressants (including biologics) for at least three months, failing to achieve partial remission or unable to maintain efficacy during glucocorticoid tapering.
Who cannot join
- -Individuals with a history of severe drug allergies or an allergic constitution.
- Presence or suspected presence of uncontrolled or treatable fungal, bacterial, viral, or other infections.
- Active, severe central nervous system disorders caused by autoimmune or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis).
- Patients with cardiac insufficiency.
- Patients with congenital immunoglobulin deficiency.
- History of malignant tumours within the past five years.
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- End-stage renal disease (excluding lupus nephritis (LN) patients).
- Hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive with peripheral blood hepatitis B virus (HBV) DNA > upper limit of normal; hepatitis C virus (HCV) antibody positive with peripheral blood hepatitis C virus (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; positive syphilis test.
- Individuals with psychiatric disorders or severe cognitive impairment.
- Participants who have been enrolled in another clinical trial within the three months preceding study entry.
- Individuals who have received immunosuppressive agents or biological agents for therapeutic indications within five half-lives prior to study entry.
- Pregnant women or women planning pregnancy.
- Individuals deemed by the investigator to have other conditions rendering them unsuitable for inclusion in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Preliminary Pharmacodynamics of Allogeneic CD19/BCMA-Targeted CAR-γδT Cell Therapy in Patients With Relapsed/Refractory Autoimmune Diseases
This study is a single-arm, intervention, dose-escalation clinical trial to evaluate the safety of allogeneic CD19/BCMA-targeted CAR-γδT cell in the treatment of relapsed/refractory autoimmune diseases
- Conditions
- Refractory/Relapsed Systemic Lupus Erythematosus, Refractory / Relapsed / Progressive Systemic Sclerosis, Refractory / Relapsing / Progressive Inflammatory Myopathy, Refractory / Relapsed Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis, Refractory / Relapsed Connective Tissue Disease-Associated Thrombocytopenia
- Being tested
- Allogeneic CD19/BCMA-targeted CAR-γδT cell injection, Cyclophosphamide, Fludarabine
- Keywords
- CD19/BCMA, CAR-γδT, cell therapy
- Medical subject headings
- Lupus Erythematosus, Systemic, Scleroderma, Diffuse, Recurrence, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic CD19/BCMA-targeted CAR-γδT cell injectionBiological
Biological: Allogeneic CD19/BCMA-targeted CAR-γδT cell. Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine), patients will be treated with dose-escalation phase (3+3 design): Dose A (5 × 10^6 CAR+cells) ,Dose B(1 × 10^7 CAR+cells), Dose C (1.5 × 10^7 CAR+cells).
CyclophosphamideDrug
Eligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises cyclophosphamide (300 mg/m² administered 3 days).
FludarabineDrug
Eligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises fludarabine (30 mg/m² administered 3 days).
| Study group | Role | What they receive |
|---|---|---|
| Patients with relapsed/refractory autoimmune diseases | Experimental | A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered, followed by the investigational therapy: allogeneic CD19/BCMA-targeted CAR-γδT cells.
Interventions:
Biological: Allogeneic CD19/BCMA-targeted CAR-γδT cell injection Drug: Fludarabine Drug: Cyclophosphamide Receives: Biological: Allogeneic CD19/BCMA-targeted CAR-γδT cell injection; Drug: Cyclophosphamide; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Measured: 6 months
Incidence of Dose-Limiting Toxicities (DLTs)
Measured: First infusion date of allogeneic CD19/BCMA-targeted CAR-γδT cell to 28 days end cell infusion
Secondary outcomes (3)
PK(Pharmacokinetics):Number and Copy Number of CD19/BCMA-targeted CAR-γδT cells
Number and copy number of CD19/BCMA-targeted CAR-γδT cells were assessed by number in peripheral blood. Blood samples were collected before and one year after cell infusion (until CD19/BCMA-targeted CAR-γδT cells were not detected for two consecutive times) to detect the number and copy number of CD19/BCMA-targeted CAR-γδT cells, and to evaluate the pharmacokinetics of CD19/BCMA-targeted CAR-γδT cells.
Measured: 12 months
PK(Pharmacokinetics): Persistence of CD19/BCMA-targeted CAR-γδT cells
Persistence of CD19/BCMA -targeted CAR-γδT cells assessed by number in peripheral blood.
Measured: 12 months
PD(Pharmacodynamics)：Peak Level of Cytokines in Serum
The cytokines mainly include interleukin-2 (IL-2 ), IL-6, IL-8, IL-10, interferon-γ（IFN-γ). Peak was defined as the maximum post-baseline level of the cytokine.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory/Relapsed Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- 9 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490275
- Sponsor's protocol ID
- IIT2026017
- Status last verified
- Jun 2026
- First submitted
- 6 Feb 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to the data underlying this study can be obtained from the corresponding author upon reasonable request and subject to any required ethical approvals.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Preliminary Pharmacodynamics of Allogeneic CD19/BCMA-Targeted CAR-γδT Cell Therapy in Patients With Relapsed/Refractory Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07490275
- Acronym / sponsor ID
- IIT2026017
- Conditions
- Refractory/Relapsed Systemic Lupus Erythematosus, Refractory / Relapsed / Progressive Systemic Sclerosis, Refractory / Relapsing / Progressive Inflammatory Myopathy, Refractory / Relapsed Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis, Refractory / Relapsed Connective Tissue Disease-Associated Thrombocytopenia
- Keywords
- CD19/BCMA, CAR-γδT, cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Mar 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.
This study is a single-arm, intervention, dose-escalation clinical trial to evaluate the safety of allogeneic CD19/BCMA-targeted CAR-γδT cell in the treatment of relapsed/refractory 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 |
|---|---|---|
| Patients with relapsed/refractory autoimmune diseases | Experimental | Biological: Allogeneic CD19/BCMA-targeted CAR-γδT cell injection, Drug: Cyclophosphamide, Drug: FludarabineA conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered, followed by the investigational therapy: allogeneic CD19/BCMA-targeted CAR-γδT cells. Interventions: Biological: Allogeneic CD19/BCMA-targeted CAR-γδT cell injection Drug: Fludarabine Drug: Cyclophosphamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- Age ≥18 years (including 18 years), no gender restrictions.
- Confirmed by flow cytometry to express CD19 or BCMA antigen on the surface of peripheral blood B cells.
- Major organ function must meet the following requirements (excluding abnormalities related to active autoimmune disease):
- Bone marrow function: Neutrophil count ≥ 1 × 10^9/L (no colony-stimulating factor therapy within 2 weeks prior to testing); Haemoglobin ≥ 60 g/L.
- Liver function: Alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN) (excluding ALT elevation due to inflammatory myopathy) ; Aspartate Aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy); Total Bilirubin (TBIL) ≤ 2 times ULN (may be relaxed to ≤ 3.0 times ULN for subjects with Gilbert's syndrome).
Key exclusion criteria (13 listed)
- -Individuals with a history of severe drug allergies or an allergic constitution.
- Presence or suspected presence of uncontrolled or treatable fungal, bacterial, viral, or other infections.
- Active, severe central nervous system disorders caused by autoimmune or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis).
- Patients with cardiac insufficiency.
- Patients with congenital immunoglobulin deficiency.
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 |
|---|---|---|
| Allogeneic CD19/BCMA-targeted CAR-γδT cell injectionBiological: Allogeneic CD19/BCMA-targeted CAR-γδT cell. Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine), patients will be treated with dose-escalation phase (3+3 design): Dose A (5 × 10^6 CAR+cells) ,Dose B(1 × 10^7 CAR+cells), Dose C (1.5 × 10^7 CAR+cells). | Biological | Patients with relapsed/refractory autoimmune diseases |
| CyclophosphamideEligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises cyclophosphamide (300 mg/m² administered 3 days). | Drug | Patients with relapsed/refractory autoimmune diseases |
| FludarabineEligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises fludarabine (30 mg/m² administered 3 days). | Drug | Patients with relapsed/refractory autoimmune diseases |
Primary outcome
Adverse Event
Time frame: 6 months
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: First infusion date of allogeneic CD19/BCMA-targeted CAR-γδT cell to 28 days end cell infusion
3 secondary outcomes
PK(Pharmacokinetics):Number and Copy Number of CD19/BCMA-targeted CAR-γδT cells
Time frame: 12 months
PK(Pharmacokinetics): Persistence of CD19/BCMA-targeted CAR-γδT cells
Time frame: 12 months
PD(Pharmacodynamics)：Peak Level of Cytokines in Serum
Time frame: 12 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 9 Jun 2026.
- Individual participant dataSharing planned: No. Access to the data underlying this study can be obtained from the corresponding author upon reasonable request and subject to any required ethical approvals.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Allogeneic CD19/BCMA-targeted CAR-γδT cell injection, Cyclophosphamide and Fludarabine in people with Refractory/Relapsed Systemic Lupus Erythematosus and Refractory / Relapsed / Progressive Systemic Sclerosis, run by Institute of Hematology & Blood Diseases Hospital, 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 37 inclusion and 13 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 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ying Wang (+86 15900225626, wangying1@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (time frame: 6 months). 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 9 Jun 2026.