Systemic Sclerosis (SSc)Early Phase 1NCT07527936

A Study of BEN301 Injection in theTreatment of Autoimmune Diseases

A Early Phase 1 study testing Single administration of 1x10^8 viable CD4+ CAR+ Foxp3+ cells. and Single administration of 3x10^8 viable CD4+ CAR+ Foxp3+ cells. in people with Systemic Sclerosis (SSc) and Rheumatoid Arthritis (RA), run by RenJi Hospital at 1 site in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA), Sjogren's Syndrome (SS)
What is being tested?: Single administration of 1x10^8 viable CD4+ CAR+ Foxp3+ cells. and Single administration of 3x10^8 viable CD4+ CAR+ Foxp3+ cells.
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 20 Apr 2026to 28 Feb 2029
Phase: Early Phase 1
Are there results?: None posted in the registry

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Voluntary participation in the study, providing written informed consent, and willingness and ability to comply with the protocol.
Age 18-70 years (inclusive) at the time of signing informed consent.
Expected survival ≥ 12 months.
Disease-Specific Criteria
Systemic Sclerosis (SSc)

Show all 34Show fewer

Diagnosis of Systemic Sclerosis according to the 2013 ACR/EULAR Classification Criteria for SSc, with a total score ≥ 9.
Disease duration (defined as time from onset of first non-Raynaud's phenomenon manifestation) ≤ 6 years. If disease duration > 6 years at screening, the participant may be enrolled if the investigator determines potential benefit and following discussion with the medical monitor of the BEN301 manufacturing site.
Evidence of active disease at screening meeting at least one of the following criteria: o Modified Rodnan Skin Score (mRSS) ≥ 10 and ≤ 35;
Increase in mRSS ≥ 3 points compared to the most recent assessment within 6 months;o Increase in mRSS ≥ 2 points with involvement of a new body region compared to the most recent assessment within 6 months;
Increase in mRSS ≥ 1 point with involvement of two new body regions within 6 months;
Progressive Interstitial Lung Disease (ILD) meeting the following standards: Inadequate response or intolerance to at least one prior treatment (including cyclophosphamide, methotrexate, mycophenolate/mycophenolic acid, nintedanib, rituximab, or tocilizumab);
AND at least one of the following:Evidence of progression on High-Resolution Computed Tomography (HRCT); ORForced Vital Capacity (FVC) < 80% predicted, Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) < 80% predicted, evidence of FVC decrease (absolute) ≥ 10%, or FVC decrease 5%-9% with DLCO decrease ≥ 15%.• Inadequate response or intolerance to conventional therapies (glucocorticoids and immunosuppressants).
Rheumatoid Arthritis (RA)
Diagnosis of RA according to the 1987 ACR or 2010 ACR/EULAR classification criteria.
Inadequate response, intolerance, or contraindication to at least one conventional synthetic DMARD (csDMARD) and at least one targeted synthetic DMARD (tsDMARD) or biologic DMARD (bDMARD), failing to achieve remission or low disease activity.
Moderate-to-severe active RA at screening, defined as ≥ 4 tender joints (of 68 assessed) and ≥ 4 swollen joints (of 66 assessed).
Erythrocyte Sedimentation Rate (ESR) > 28 mm/hr and/or C-reactive protein (CRP) > 10 mg/L.• Positive Rheumatoid Factor (RF) and/or Anti-Citrullinated Protein Antibody (ACPA).• Duration of RA diagnosis > 6 months.
Primary Sjögren's Syndrome (pSS)
Meets the 2016 ACR/EULAR Classification Criteria for Sjögren's Syndrome.• High disease activity index: ESSDAI ≥ 6 points.
Inadequate response or intolerance to conventional therapies (glucocorticoids and immunosuppressants).
Positive for Anti-Sjögren's Syndrome A (SSA) and/or Anti-Sjögren's Syndrome B (SSB) antibodies.
Idiopathic Inflammatory Myopathies (IIM)
Suspected or confirmed diagnosis of Polymyositis (PM) or Dermatomyositis (DM) according to the 2017 EULAR/ACR Classification Criteria.
Moderate-to-severe PM or DM, defined as meeting both Part A and Part B below: Part A: Manual Muscle Testing (MMT-8) total score < 142. Part B: At least 2 of the following 5 items: Physician Global Assessment (PhGA, 10-cm VAS) ≥ 2 cm; Patient Global Assessment (PtGA, 10-cm VAS) ≥ 2 cm; Health Assessment Questionnaire-Disability Index (HAQ-DI) > 0.25; Elevation of any muscle enzyme (CK, LDH, AST, ALT) ≥ 1.3 × Upper Limit of Normal (ULN); Myositis Disease Activity Assessment Tool (MDAAT) global extramuscular activity (10-cm VAS) ≥ 2 cm.
Alternatively, presence of active disease: evidence of active muscle inflammation on MRI or muscle biopsy within 12 weeks.
5. Adequate Organ Function Within 7 days prior to screening (without transfusion, hematopoietic growth factors within 2 weeks, or medication correction):
Bone Marrow: o Hemoglobin (Hb) ≥ 80 g/L;o Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L;o Platelet count (PLT) ≥ 50 × 10⁹/L.• Renal Function: Creatinine Clearance (CrCl, calculated by Cockcroft-Gault formula, see Appendix 1) ≥ 50 mL/min (without hydration assistance).
Hepatic Function: Serum ALT and AST ≤ 2.5 × ULN (exceptions for CK-induced elevations may be determined by the investigator); Total bilirubin ≤ 1.5 × ULN.• Pulmonary Function: Oxygen saturation ≥ 92% on room air without supplemental oxygen; no clinically significant pleural effusion.
Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 40%; no pericardial effusion; ECG at screening showing no clinically significant abnormalities.
Coagulation: Fibrinogen ≥ 1.5 g/L; Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN; Prothrombin Time (PT) ≤ 1.5 × ULN.4. Biological Requirements
Presence of CD19+ B cells in peripheral blood.• Adequate venous access for leukapheresis, without contraindications to leukapheresis.5. Reproductive Criteria
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening. (Women who are surgically sterile or postmenopausal for at least 2 years are considered non-childbearing).
Sexually active WOCBP and male participants must agree to use highly effective contraception from the time of signing informed consent until 1 year after the last study treatment, and must not donate eggs/sperm for assisted reproduction during this period.

Who cannot join

Severe Renal Disease
History of severe nephritis or nephrotic syndrome.
Severe is defined as:
Prior receipt of any of the following treatments within specified timeframes: Prior kidney transplantation; Dialysis or plasmapheresis within 3 months prior to screening; Glucocorticoid pulse therapy (defined as ≥500 mg/day prednisone or equivalent) within 1 month prior to screening.Requirement for any of the following treatments during the study period: Use of prohibited medications per protocol; Need for dialysis or plasmapheresis; Need or planned kidney transplantation.
Severe Cardiovascular Disease
History of severe cardiovascular disease, including but not limited to: symptomatic chronic heart failure requiring intervention, acute myocardial infarction or coronary artery bypass grafting within 6 months, unstable angina, history of severe arrhythmia, or history of stroke.

Show all 34Show fewer

New York Heart Association (NYHA) Class III-IV heart failure.• QTcF interval > 450 ms (male) or > 470 ms (female) on screening ECG (Fridericia formula: QTcF = QT / (RR^0.33)).
SSc-Specific Exclusions• Receipt of oral, intramuscular, or intravenous glucocorticoids (>10 mg/day prednisone or equivalent) within 1 week prior to leukapheresis. (Note: Investigators may consider dose reduction prior to leukapheresis/infusion provided the participant's disease is controlled).
Receipt of immunosuppressants within 1 week prior to leukapheresis, including but not limited to methotrexate, hydroxychloroquine, cyclosporine A, azathioprine, mycophenolate, sirolimus, colchicine, or D-penicillamine.
RA-Specific Exclusions • Use of anti-TNF agents within 8 weeks prior to dosing (or 4 weeks for etanercept).
Use of any JAK inhibitor within 2 weeks prior to dosing.
Use of other biologics or non-B-cell depleting investigational drugs within fewer than 5 half-lives prior to dosing.
pSS-Specific Exclusions
Diagnosis of secondary Sjögren's syndrome (defined as overlap with other autoimmune or systemic inflammatory diseases, e.g., RA, SLE, scleroderma, or idiopathic inflammatory myopathy).
Severe systemic involvement assessed by the investigator, including: o Serious vasculitis involving kidneys, digestive system, heart, lungs, or CNS (excluding cutaneous vasculitis);o Active CNS or PNS involvement requiring high-dose glucocorticoids;o Severe renal involvement (e.g., GFR < 60 mL/min);o Severe pulmonary involvement (e.g., dyspnea at rest, or FVC < 60% or DLCO < 40%);o Myopathy requiring high-dose glucocorticoids;o Lymphoma.
Use of sodium hyaluronate eye drops, artificial tears, artificial saliva, or sialogogues (e.g., pilocarpine) within 7 days prior to dosing; use of immunosuppressants (e.g., cyclophosphamide, leflunomide, methotrexate, azathioprine) within 4 weeks prior to dosing; use of JAK inhibitors or other kinase inhibitors within 2 weeks prior to dosing; use of targeted biologics (e.g., Telitacicept, Belimumab, Abatacept, Adalimumab) within 6 weeks prior to dosing.
Requirement for medications causing dry mouth/dry eyes during the study.
IIM-Specific Exclusions
Participants with a record of Inclusion Body Myositis (IBM), juvenile myositis, drug-induced PM/DM, cancer-associated PM/DM (defined as cancer diagnosed within 3 years of PM/DM diagnosis), or non-inflammatory myopathies (e.g., muscular dystrophies).
Patients with PM/DM who have a high risk of malignancy.• Permanent muscle weakness due to causes other than PM/DM (e.g., stroke) as judged by the investigator.• Any of the following prior treatments/procedures: o Topical corticosteroids or topical immunomodulators (e.g., tacrolimus) for IIM-associated rash within ≤ 1 week prior to dosing;o JAK inhibitors within 2 weeks prior to dosing;o Cyclophosphamide, rituximab, or other anti-CD20 antibodies within 12 weeks prior to dosing;o Other investigational products within 4 weeks or 5 half-lives (whichever is longer) prior to dosing;o Combination therapy with >1 immunosuppressant, >1 antimalarial, or immunosuppressants plus antimalarials within 2 weeks prior to dosing.
Other Autoimmune Diseases
History of other autoimmune diseases excluding the target indications, including Eosinophilic Granulomatosis with Polyangiitis (EGPA), Henoch-Schönlein purpura, cryoglobulinemic vasculitis, anti-glomerular basement membrane disease, Behçet's disease, or Takayasu arteritis.
Malignancy
History of malignancy within 5 years prior to enrollment, including patients with tumor-associated PM/DM. Exceptions include: surgically removed and cured non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, low-stage bladder cancer, ductal carcinoma in situ of the breast, or patients cured with no evidence of recurrence in the past 2 years requiring no treatment.
Hypersensitivity
Known allergy, hypersensitivity, intolerance, or contraindication to BEN301 or any component of the study medications; or history of severe allergic reactions.
Prior Cell Therapy• Prior receipt of autologous/allogeneic hematopoietic stem cell transplantation or CAR-T cell therapy.
Recent Procedures/Vaccinations• Major surgery, live vaccine administration, or participation in other clinical trials within 1 month prior to screening.
Active Infection
Uncontrolled active infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to screening (prophylactic treatment excluded); active tuberculosis (excluded if T-SPOT positive).
Viral Serology
Positive serology for Hepatitis B (HBsAg positive regardless of HBV-DNA level), Hepatitis C (HCVAb positive), HIV (HIV antibody positive), or Syphilis (confirmed TPPA positive) at screening.
Prohibited Medications• Use of medications/treatments prohibited by the protocol during screening.
Investigator's Discretion• Any other condition deemed unsuitable for study participation by the investigator, such as certain psychiatric disorders, dementia, suicidal ideation, or poor compliance.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, 200127

Other trials in China

About this study

Official title: A Phase I Exploratory Study on the Safety and Efficacy of BEN301 Injection in the Treatment of Autoimmune Diseases

The study aims to investigate the safety, tolerability, and preliminary clinical efficacy of BEN301 Injection in patients with autoimmune diseases. In patients with autoimmune diseases, Treg cells are typically deficient or dysfunctional. CAR-Treg cell therapy represents a promising strategy for the treatment of autoimmune diseases and may be applicable to a broad spectrum of autoimmune conditions. Preclinical studies have shown that BEN301 Injection not only effectively suppresses the aberrant activation of T and B cells in SLE models, but also significantly reduces total lgG secretion and the production of SLE-specific autoantibodies, particularly anti-double-stranded DNA (dsDNA) antibodies. Moreover, no significant treatment-related toxicities were observed. Treg cell therapy has already demonstrated favorable efficacy in multiple indications, including organ transplantation and autoimmune diseases, with a well-established safety and tolerability profile. Meanwhile, CAR-Treg cell therapy has been actively explored in various autoimmune conditions; several products have shown therapeutic potential, and some patients have already benefited from treatment. These findings highlight the promising prospects of CAR-Treg cell therapy in the management of autoimmune diseases.

Conditions: Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA), Sjogren's Syndrome (SS), Idiopathic Inflammatory Myopathies(IIM)
Being tested: Single administration of 1x10^8 viable CD4+ CAR+ Foxp3+ cells., Single administration of 3x10^8 viable CD4+ CAR+ Foxp3+ cells.
Medical subject headings: Scleroderma, Systemic, Arthritis, Rheumatoid, Sjogren's Syndrome, Myositis

What participants receive

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

Single administration of 1x10^8 viable CD4+ CAR+ Foxp3+ cells.Biological
Lymphodepletion is generally not required; however, if Treg expansion issuboptimal, lymphodepletion may be administered as needed, or low-dose IL-2 may be combined. The recommended lymphodepletion regimens include: Cyclophosphamide monotherapy (CTX 900-1000 mg/m2 on day -3,or CTX 300 mg/m^2 from day -5 to day -3); or cyclophosphamide combined with fludarabine (12.5-25 mg/m^2 from day -5 to day -3); - or low-dose IL-2 administered after cell infusion.
Single administration of 3x10^8 viable CD4+ CAR+ Foxp3+ cells.Biological
Lymphodepletion is generally not required; however, if Treg expansion issuboptimal, lymphodepletion may be administered as needed, or low-dose IL-2 may be combined. The recommended lymphodepletion regimens include: Cyclophosphamide monotherapy (CTX 900-1000 mg/m2 on day -3,or CTX 300 mg/m^2 from day -5 to day -3); or cyclophosphamide combined with fludarabine (12.5-25 mg/m^2 from day -5 to day -3); - or low-dose IL-2 administered after cell infusion.

Study groups in NCT07527936
Study group	Role	What they receive
BEN301 Low-dose group	Experimental	Single administration of 1x10^8 viable CD4+CAR+ Foxp3+ cells. Receives: Biological: Single administration of 1x10^8 viable CD4+ CAR+ Foxp3+ cells.
BEN301 High-dose group	Experimental	Single administration of 3x10^8 viable CD4+CAR+ Foxp3+ cells Receives: Biological: Single administration of 3x10^8 viable CD4+ CAR+ Foxp3+ cells.

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose-Limiting Toxicity (DLT)
Proportion of participants experiencing dose- limiting toxicity (DLT) within 28 days after infusion, determination of the MTD or RP2D
Measured: Days 28
Adverse Event (AE)
Incidence and proportion of adverse events occurring after infusion.
Measured: AEs occuring from informed consent signing through Wek 12 post infusion. Thereafte, only AEs related to the investigational product will be collected through study completion, an average of 2 years.

Secondary outcomes (4)

Modified Rodnan Skin Score (mRSS)
Change fom baseline in modifed Rodnan Skin Score (mRSS) at Week 12 after the first infusion of BEN301 Injection The minimum value of the modifed Rodnan skin scale (mRSS) is 0 points, and the maximum value is 51 points. The higher the score, the more severe the degree of skin sclerosis, that is, the worse the resut. mRSS quantifies the skin invovement of systemic sclerosis by evaluating the skin hardness of 17 parts of the body. 0 points represent normal skin and 3 points represent severe thickening. The higher the total score, the more extensive and severe skin fibrosis which is associated with disease activity and poor prognosis.
Measured: Week 12
Simplified Disease Activity Index (SDAl) score
SDAl score at Week 12 after the first infusion of BEN301 Injection; percentage of patients achieving SDAl low disease activity and clinical remission. SDAI score exceeding 26 is considered high disease activity; exceeding 11 and not greater than 26, moderate disease activity; exceeding 3.3 and not greater than 11, low disease activity.
Measured: Week 12
EULAR Sjogren's Syndrome Disease Activity Index (ESSDAl) score
Change from baseline in overall disease activity (ESSDAl) at Week 12 after the first infusion of BEN301 Injection. The ESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with primary Sjogren's syndrome. The ESSDAI includes 12 domains divided into 4 activity levels, where zero represents no activity. A higher score means a worse outcome.
Measured: Week 12
Total Improvement Score (TIS)
Change from baseline in Myositis Response Criteria TIS scores at Week 12 after the first infusion of BEN301 Injection. The Total Improvement Score (TIS) is a standardized composite measure developed to quantify treatment response in idiopathic inflammatory myopathies(IIM). The TIS ranges from 0 to 100,with higher scores reflecting greater improvement.
Measured: Week 12

Timeline

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

20 Apr 202628 Feb 2029

First posted14 Apr 2026
Study start20 Apr 2026
Primary completion31 Aug 2028 (estimated)
Study completion28 Feb 2029 (estimated)

Why it stopped: company's decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Systemic Sclerosis (SSc)Studies of the same condition, open and under way.
More trials run by RenJi 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: Early Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07527936
Sponsor's protocol ID: BEN301IIT1
Status last verified: Jun 2026
First submitted: 7 Apr 2026
Last updated: 4 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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

Questions to ask the study team

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

See locations

RecruitingObservational study
Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
Systemic Sclerosis (SSc), Calcinosis Cutis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
RecruitingPhase 1
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Recruiting
Tissue Modeling in Systemic Sclerosis Using Induced Pluripotent Stem Cells (iPSCs)
Systemic Sclerosis (SSc)

All Systemic Sclerosis (SSc) trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Exploratory Study on the Safety and Efficacy of BEN301 Injection in the Treatment of Autoimmune Diseases
ClinicalTrials.gov ID: NCT07527936
Acronym / sponsor ID: BEN301IIT1
Conditions: Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA), Sjogren's Syndrome (SS), Idiopathic Inflammatory Myopathies(IIM)
Phase: Early Phase 1
Study type: Interventional
Recruitment status: SuspendedReason stopped: company's decision
Enrolment: 24 participants (estimated)
Lead sponsor: RenJi HospitalUniversity, hospital or other
Study start: 20 Apr 2026 (actual)
Primary completion: 31 Aug 2028 (estimated)
Study completion: 28 Feb 2029 (estimated)
First posted: 14 Apr 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BEN301 Low-dose group	Experimental	Biological: Single administration of 1x10^8 viable CD4+ CAR+ Foxp3+ cells.Single administration of 1x10^8 viable CD4+CAR+ Foxp3+ cells.
BEN301 High-dose group	Experimental	Biological: Single administration of 3x10^8 viable CD4+ CAR+ Foxp3+ cells.Single administration of 3x10^8 viable CD4+CAR+ Foxp3+ cells

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (34 listed)

Voluntary participation in the study, providing written informed consent, and willingness and ability to comply with the protocol.
Age 18-70 years (inclusive) at the time of signing informed consent.
Expected survival ≥ 12 months.
Disease-Specific Criteria

Key exclusion criteria (34 listed)

Severe Renal Disease
Prior receipt of any of the following treatments within specified timeframes: Prior kidney transplantation; Dialysis or plasmapheresis within 3 months prior to screening; Glucocorticoid pulse therapy (defined as ≥500 mg/day prednisone or equivalent) within 1 month prior to screening.Requirement for any of the following treatments during the study period: Use of prohibited medications per protocol; Need for dialysis or plasmapheresis; Need or planned kidney transplantation.
Severe Cardiovascular Disease
SSc-Specific Exclusions• Receipt of oral, intramuscular, or intravenous glucocorticoids (>10 mg/day prednisone or equivalent) within 1 week prior to leukapheresis. (Note: Investigators may consider dose reduction prior to leukapheresis/infusion provided the participant's disease is controlled).
RA-Specific Exclusions • Use of anti-TNF agents within 8 weeks prior to dosing (or 4 weeks for etanercept).

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
Single administration of 1x10^8 viable CD4+ CAR+ Foxp3+ cells.Lymphodepletion is generally not required; however, if Treg expansion issuboptimal, lymphodepletion may be administered as needed, or low-dose IL-2 may be combined. The recommended lymphodepletion regimens include: Cyclophosphamide monotherapy (CTX 900-1000 mg/m2 on day -3,or CTX 300 mg/m^2 from day -5 to day -3); or cyclophosphamide combined with fludarabine (12.5-25 mg/m^2 from day -5 to day -3); - or low-dose IL-2 administered after cell infusion.	Biological	BEN301 Low-dose group
Single administration of 3x10^8 viable CD4+ CAR+ Foxp3+ cells.Lymphodepletion is generally not required; however, if Treg expansion issuboptimal, lymphodepletion may be administered as needed, or low-dose IL-2 may be combined. The recommended lymphodepletion regimens include: Cyclophosphamide monotherapy (CTX 900-1000 mg/m2 on day -3,or CTX 300 mg/m^2 from day -5 to day -3); or cyclophosphamide combined with fludarabine (12.5-25 mg/m^2 from day -5 to day -3); - or low-dose IL-2 administered after cell infusion.	Biological	BEN301 High-dose group

Primary outcome

Dose-Limiting Toxicity (DLT)
Time frame: Days 28
Proportion of participants experiencing dose- limiting toxicity (DLT) within 28 days after infusion, determination of the MTD or RP2D
Adverse Event (AE)
Time frame: AEs occuring from informed consent signing through Wek 12 post infusion. Thereafte, only AEs related to the investigational product will be collected through study completion, an average of 2 years.
Incidence and proportion of adverse events occurring after infusion.

4 secondary outcomes

Modified Rodnan Skin Score (mRSS)
Time frame: Week 12
Simplified Disease Activity Index (SDAl) score
Time frame: Week 12
EULAR Sjogren's Syndrome Disease Activity Index (ESSDAl) score
Time frame: Week 12
Total Improvement Score (TIS)
Time frame: Week 12

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
Individual participant dataSharing planned: Undecided

Related trials for Systemic Sclerosis (SSc)

RecruitingObservational study
Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
Systemic Sclerosis (SSc), Calcinosis Cutis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
RecruitingPhase 1
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Recruiting
Tissue Modeling in Systemic Sclerosis Using Induced Pluripotent Stem Cells (iPSCs)
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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 34 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: paused, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) (time frame: Days 28). 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?

On the ClinicalTrials.gov record for NCT07527936.

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 4 Jun 2026.