HRYZ-T102 TCR-T Cell for AFP Positive Advanced HCC and Other Solid Tumors
Trial Parameters
Brief Summary
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of HRYZ-T102 TCR-T Cell in patients with AFP positive advanced hepatocellular carcinoma and other solid tumors refractory to prior systematic treatments.
Eligibility Criteria
Inclusion Criteria: 1. The patient must be willing to sign the informed consent form. 2. Age ≥18 years and ≤75 years. 3. HLA-A 02:03 allele positive 4. 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. 5. Fresh samples or formalin-fixed paraffin-embedded (FFPE) samples, immunohistochemistry (IHC)-stained AFP positive or serum AFP ≥400ng/ml. 6. Barcelona Clinic Liver Cancer (BCLC) stage C or B and Child-Pugh ≤7 7. ECOG performance status ≤1. 8. Estimated life expectancy ≥4 months. 9. Patients must have at least one measurable lesion defined by RECIST 1.1. 10. 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 ; Cre