📋 Eligibility rules (as published)
Inclusion Criteria:
1. Voluntary signing of the Informed Consent Form (ICF)
2. Age range: At the time of signing the ICF, the age is between 18 and 60 years old (including 18 and 60 years old), regardless of gender.
3. No systemic active infection within 2 weeks before screening.
4. Contraceptive requirements for participants with child - bearing potential.
5. Negative pregnancy test for women with child - bearing potential. Inclusion Criteria for SLE
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1. Meet the EULAR/ACR 2019 SLE classification criteria with a disease history ≥ 6 months.
2. Treatment and disease activity requirements:
o Before screening, the participant must have received treatment with glucocorticoids combined with immunosuppressive agents (including cyclophosphamide, mycophenolate mofetil, tacrolimus, methotrexate, cyclosporine, leflunomide) and/or biological agents for ≥ 3 months, with a stable dose for ≥ 2 weeks, and the disease is still in an active state. Oral corticosteroid requirements at the time of screening:
o If treated with corticosteroids alone, prednisone (or equivalent drug) ≥ 7.5 mg/day.
o When used in combination with immunosuppressive agents and/or biological agents, there is no minimum daily dose requirement for corticosteroids.
3. Positive antibody test at screening: Positive antinuclear antibody, and/or positive anti-ds-DNA antibody, and/or positive anti-Smith antibody.
4. Disease activity score or organ damage: At the screening stage, the SLEDAI - 2K score is ≥ 7 points
5. Active organ involvement at screening: isolated skin and mucous membrane involvement is not eligible for inclusion.
6. Adequate organ function:
o Renal function: Defined as a calculated creatinine clearance rate (Cockcroft - Gault) ≥ 50 mL/min without the need for hydration assistance.
o Bone marrow function: Defined as absolute neutrophil count (ANC) ≥ 1.0×10⁹/L and hemoglobin (Hb) ≥ 60 g/L. Blood transfusion and growth factors should not be used to meet these requirements within 7 days before the inclusion and exclusion screening.
o Liver function: Defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2× the upper limit of normal (ULN), and total bilirubin ≤ 2× the upper limit of normal (ULN).
o Coagulation function: Defined as international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
o Lung function: Oxygen saturation (SpO₂) ≥ 92% (measured by pulse oximeter) in room air.
* Cardiac function: Defined as a left ventricular ejection fraction (LVEF) ≥ 40% as evaluated by echocardiogram (ECHO) within 8 weeks before screening.
Inclusion Criteria for SSc
1. Meet the 2013 EULAR/ACR classification criteria for systemic sclerosis and the diffuse - type manifestation simultaneously.
2. Combined with interstitial pneumonia caused by SSc.
3. Meet the definition of refractory or progressive disease:
o Refractory disease definition: Ineffective after more than 6 months of conventional treatment, or disease recurrence after remission. Conventional treatment is defined as the use of glucocorticoids (more than 1 mg/kg/d) or cyclophosphamide, and one or more of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including Actemra, Rituxan, belimumab, tabitacicept, etc.
* Progressive disease definition (in the past 6 months):
* Skin progression: An increase in mRSS \> 10%.
* Lung disease progression: A 10% decrease in FVC, or a 5% decrease in FVC accompanied by a 15% decrease in DLCO.
4. Important organ function:
o Renal function: Defined as a calculated creatinine clearance rate (Cockcroft - Gault) ≥ 50 mL/min without the need for hydration assistance.
o Bone marrow function: Defined as absolute neutrophil count (ANC) ≥ 1.0×10⁹/L and hemoglobin (Hb) ≥ 90 g/L. Blood transfusion and growth factors should not be used to meet these requirements within 7 days before the inclusion and exclusion screening.
o Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2× the upper limit of normal (ULN), and total bilirubin ≤ 2× the upper limit of normal (ULN).
o Coagulation function: INR ≤ 1.5×ULN, prothrombin time (PT) ≤ 1.5×ULN.
o Cardiac function: Good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 40%.
Exclusion Criteria:
1. Previous history of CAR-T cell or other genetically modified T-cell therapies, or previous major organ transplantation.
2. Use of B-cell targeted drugs (such as rituximab) within 2 months before screening.
3. Allergy or intolerance to lymphodepletion drugs, tocilizumab, or life-threatening allergic reactions, hypersensitivity reactions, or intolerance to the CT1190B preparation or its excipients, or a history of other severe allergies such as anaphylactic shock.
4. Use of corticosteroids ≥ 10 mg/day of prednisone (or equivalent drug) within 10 days before the infusion of CT1190B.
5. Use of immunosuppressive agents that affect T-cells (mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, tacrolimus) within 10 days before the infusion of CT1190B.
6. Use of JAK inhibitors (tofacitinib, baricitinib tablets, ruxolitinib, etc.) within 3 days before the infusion of CT1190B.
7. Vaccination with live-attenuated vaccines, inactivated vaccines, or RNA vaccines within 1 month before screening.
8. Diagnosis of cancer within 2 years before signing the ICF. Exceptions include non-melanoma skin cancer treated by radical therapy, local prostate cancer, biopsy-proven cervical carcinoma in situ or squamous intraepithelial lesions detected by cervical smear, and completely resected breast carcinoma in situ.
9. Undergoing major surgery within 4 weeks before signing the ICF, or planning to undergo major surgery during the study, and the investigator deems it will pose an unacceptable risk to the participant.
10. Positive