HRYZ-T102 TCR-T Cell for AFP Positive Advanced HCC and Other Solid Tumors

Korábbi kezelés

• Toxicity of previous treatment has not been mitigated or ≤ Grade 1 at screening.
• With severe cardiovascular disease or presence of clinically-relevant central nervous system (CNS) disorders in six months before screening.
• Current presence of or previously with hepatic encephalopathy
• Have a history of gastrointestinal bleeding or a definite tendency to gastrointestinal bleeding within 3 months before screening
• Subject has active infection or unexplained fever during screening and prior to cell transfusion

Más betegség

• Another primary malignancy within 5 years (with some exceptions for completely-resected early-stage tumors)
• Systematic autoimmune disorders requiring long-term systematic immunosuppression
• Have a history of hypersensitivity to cyclophosphamide or fludarabine, and it is known that any ingredient used in the treatment of this study will produce allergic reactions.
• Hereditary or acquired bleeding (e.g. coagulation dysfunction) or a tendency to clot
• Known HIV or syphilis infection, and/or active hepatitis C virus infection.
• HBV infect subjects with HBV-DNA≥2000IU/ml
• Known uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure

Egyéb

• Organ transplanters and allogeneic cell transplanters.
• Have central nervous system metastasis with symptoms
• Pregnant or lactating female, or those whose HCG test is positive before enrollment.

• The patient must be willing to sign the informed consent form.
• Age ≥18 years and ≤75 years.
• HLA-A 02:03 allele positive
• Histologically-confirmed AFP positive hepatocellular carcinoma (HCC) or other solid tumor, No benefits from curative surgery or other local therapies are expected ,at least one prior line of systematic treatment at screening, judged by investigators.
• Fresh samples or formalin-fixed paraffin-embedded (FFPE) samples, immunohistochemistry (IHC)-stained AFP positive or serum AFP ≥400ng/ml.
• Barcelona Clinic Liver Cancer (BCLC) stage C or B and Child-Pugh ≤7
• ECOG performance status ≤1.
• Estimated life expectancy ≥4 months.
• Patients must have at least one measurable lesion defined by RECIST 1.1.
• Patients with any organ dysfunction as defined below:
  • Leukocytes≥3.0 x 10\^9/L; blood platelets ≥75 x 10\^9/L; hemoglobin≥85g/L; Absolute lymphocyte count≥0.8 x 10\^9/L Serum albumin ≥ 30g/L; total bilirubin≤3×ULN; ALT/AST≤3×ULN ; Creatinine clearance ≥50mL/min; or serum creatinine ≤1.5×ULN; INR≤1.5×ULN; APTT≤1.5×ULN; LVEF≥50%; SpO2≥92%.
• Subjects with potential fertility must agree to use effective contraceptive methods during the whole trials period and at least 1 year after receiving HRYZ-T102 cell transfusion treatment. HCG test for female with potential fertility must be negative within 7 days before apheresis.