Clinical Study of Novel TLR2-Containing CAR-T Cells Targeting CD19 and CD22 for Relapsed/Refractory B-ALL and NHL

Laborértékek

• 1.Women who are breastfeeding. 2.Patients with uncontrollable infectious diseases within 4 weeks before enrollment.
  • 3.Active hepatitis B/C. 4.HIV-infected patients. 5.Patients with severe autoimmune diseases or immunodeficiency diseases. 6.Patients with allergic constitution, allergic to antibodies or cytokines and other large molecule biological drugs.
  • 7.Patients who have participated in other clinical trials within 4 weeks before enrollment.
  • 8.History of clinically significant central nervous system diseases: such as epilepsy, paralysis, aphasia, stroke, severe brain trauma, dementia, Parkinson's disease, cerebellar diseases, organic brain syndromes.
  • 9.Patients with mental illness. 10.Patients with drug abuse/addiction. 11.Use of contraindicated medications.
  • . Steroids: Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent >20 mg/day) within 7 days before leukocyte collection, or within 72 hours before CAR-T cell infusion targeting CD19 and CD22. However, physiological replacement, topical, and inhaled corticosteroids are allowed.
  • . Chemotherapy: Received salvage chemotherapy within 2 weeks before leukocyte collection.
  • . Allogeneic cell therapy: Received donor lymphocyte infusion within 4 weeks before leukocyte collection.
  • . GVHD treatment: Received anti-GVHD treatment within 4 weeks before CAR-T cell infusion targeting CD19 and CD22.
  • . Use of alemtuzumab, or cladribine within 6 months before leukocyte collection, or use of chlorambucil or clofarabine within 3 months.

• 1. The patient or their legal guardian voluntarily participates and signs an informed consent form.
  • 2.Age between 18-80 years old (inclusive), with no gender restrictions. 3.Diagnosed with acute B-cell acute lymphoblastic leukemia or non-Hodgkin's lymphoma according to the WHO 2016 classification.
  • 4.CD19 or CD22 positivity confirmed by flow cytometry or histopathology. 5.Diagnosed with refractory/relapsed B-cell acute lymphoblastic leukemia or non-Hodgkin's lymphoma.
  • 6.Good major organ function:
  • Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and total bilirubin ≤ 34.2 μmol/L;
  • Kidney function: Creatinine clearance rate (Cockcroft-Gault method) ≥ 60 mL/min;
  • Lung function: Oxygen saturation ≥ 95%, with no active pulmonary infection;
  • Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; no significant pericardial effusion, no clinically significant ECG abnormalities.
  • 7.Women of childbearing age with negative urine/blood pregnancy test during screening and agree to use contraceptive measures for at least 1 year after infusion; male subjects with reproductive capacity must agree to use effective barrier contraceptive methods for at least 1 year after infusion.
  • 8.ECOG score ≤ 1. 9.Life expectancy greater than 3 months.