This investigator-initiated trial aims to evaluate the safety and efficacy of universal anti-CD70 CAR-T (CHT101) in patients with relapsed refractory systemic lupus erythematosus.
Meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus (SLE).
SLEDAI-2000 score >6.
Have at least one BILAG-2004 Grade A or two Grade B organ domain scores, or both.
Failure to respond to conventional therapy or disease relapse after remission. Conventional therapy: Glucocorticoids (≥1 mg/kg/day) combined with cyclophosphamide and ≥1 of the following immunosuppressants for >6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine A, and/or biologics (e.g., rituximab, belimumab, telitacicept).
Presence of neuropsychiatric lupus (NPSLE).
History of thrombotic thrombocytopenic purpura (TTP) or thrombotic microangiopathy (TMA).
History of severe drug allergies or hypersensitivity.
Active or suspected uncontrolled infections requiring treatment (including fungal, bacterial, viral, or other pathogens).
Single group
Universal anti-CD70 CAR-T (CHT101)
Biological/VaccineUniversal anti-CD70 CAR-T (CHT101) cell therpy
SRI-4 Response
SRI-4 Response defined as a decrease of ≥4 points from baseline in the SELENA-SLEDAI score, no new BILAG-evaluated grade A organs or \<2 BILAG-evaluated grade B organs from baseline, and no deterioration in the physician's overall assessment (an increase of \<0.30 points from baseline).
Safety Evaluation
Safety evaluation includes the collection of adverse events (AE), serious adverse events (SAE), vital signs and physical examinations, laboratory tests, including pregnancy tests and concomitant treatments. Safety is evaluated using the NCI-CTCAE 5.0 standard. CRS is evaluated using the ASTCT Consensus Grading Criteria, ICANS is evaluated using the Adult ASTCT ICANS Consensus Grading Criteria, acute GVHD is evaluated using the 2016 Mount Sinai Acute GVHD International Consortium Grading Criteria, and chronic GVHD is evaluated using the 2020 NCCN Hematopoietic Cell Transplantation Clinical Practice Guidelines, Version 1.0.
DORIS remission
The remission of SLE was based on the DORIS 2021 criteria, namely: SLEDAI=0 and PGA \< 0.5 (0-3 points), serology was not considered, and patients could use antimalarial drugs, low-dose glucocorticoids (prednisolone ≤5mg/ day), and/or immunosuppressants including biologics.
Lupus Low Disease Activity State (LLDAS) remission
requiring simultaneous fulfillment of all the following criteria: * SLEDAI-2K score ≤4, with no active involvement of major organs (kidneys, central nervous system, heart/lungs, gastrointestinal tract, vasculitis, or fever); * PGA score ≤1; * No new lupus-related symptoms; * Maintenance dose of prednisone (or equivalent) ≤7.5 mg/day.
Overall Renal Response (ORR)
Evaluated only in participants with lupus nephritis, encompassing those achieving either complete renal response (CRR) or partial renal response (PRR).
Complete Renal Response (CRR)
Evaluated only in participants with lupus nephritis; participants meeting all the following criteria are considered to have achieved CRR: * Urinary protein excretion \<0.5 g/24 h or urine protein-to-creatinine ratio (UPCR) \<0.5 g/g; * Estimated glomerular filtration rate (eGFR) decline ≤10-15% from baseline or eGFR ≥60 mL/min/1.73 m²; * No use of rescue medications exceeding protocol-specified thresholds prior to assessment.
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