Clinical Study of SYNCAR-100 in the Treatment of Relapsed/Refractory Acute B-Lymphoblastic Leukemia

Exclusion Criteria

• •1.Isolated extramedullary leukemia or isolated extramedullary relapse.
• •2.Central nervous system (CNS) involvement of leukemia at CNS2 stage.
• •3.A history of other malignant tumors, except for the following: cured non-melanoma skin cancer, carcinoma in situ of the uterine cervix, localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ, or other malignant tumors with disease-free survival for more than 5 years.
• •4.Positive test results for any of the following infectious diseases: HIV; HCV; HBsAg; positive HBcAb with concurrent positive HBV DNA copy number; TPPA.
• •5.Administration of live or attenuated live vaccines within 4 weeks prior to enrollment.
• •6.Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) with tyrosine kinase inhibitor (TKI) therapy within 1 week prior to enrollment.
• •7.Prior receipt of CD19-targeted therapy, CAR-T cell therapy, or other gene-edited T cell therapy.
• •8.Grade ≥2 acute graft-versus-host disease (GVHD) (per Glucksberg criteria) requiring treatment, or extensive chronic GVHD (per Seattle criteria) within 4 weeks prior to enrollment; or patients judged by the investigator to potentially require anti-GVHD therapy during the study period.
• •9.Comorbidities judged by the investigator to require systemic corticosteroid therapy or other immunosuppressive therapy during the study period; or receipt of allogeneic cellular therapy (e.g., donor lymphocyte infusion \[DLI\]) within 4 weeks prior to enrollment.
• •10.Receipt of CNS-directed radiotherapy within 4 weeks prior to enrollment.
• •11.Unresolved acute toxicities from prior therapy (excluding hematologic toxicities and alopecia) that have not recovered to Grade 1 or lower.
• •12.Known life-threatening hypersensitivity or other intolerance to the study drug, or a history of severe atopy.
• •13.Active autoimmune diseases (including but not limited to systemic lupus erythematosus, Sjögren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, Hashimoto's thyroiditis, etc.), excluding hypothyroidism that is controllable solely with hormone replacement therapy.
• •14.Receipt of major surgery requiring general anesthesia within 4 weeks prior to enrollment; or failure to recover and achieve clinical stability from prior surgical treatment; or anticipated major surgery requiring general anesthesia during the study period.
• •15.Use of other investigational drugs within 28 days prior to enrollment.
• •16.A history of any unstable cardiovascular disease within 6 months prior to enrollment, including but not limited to unstable angina pectoris, myocardial infarction, heart failure (New York Heart Association \[NYHA\] Class ≥III), severe cardiac arrhythmias requiring pharmacologic treatment; or receipt of percutaneous transluminal coronary angioplasty, coronary stenting, or coronary artery bypass grafting within 6 months prior to enrollment.
• •17.A history of central nervous system (CNS) disease or disorders (e.g., seizure disorders, cerebral vascular ischemia/hemorrhage, dementia, cerebellar disease) or any autoimmune disease involving the CNS.
• •18.Uncontrolled active infection at screening (e.g., sepsis, bacteremia, fungemia, viremia).
• •19.Any other condition judged by the investigator to make the patient unsuitable for participation in this clinical study.