A Multicenter, Single Arm, Open Label, Phase I Clinical Study to Evaluate the Safety, Tolerability and Efficacy of HRYZ-T101 Injection for HPV18 Positive Solid Tumor
A multicenter, open label, single arm dose escalation phase I study to evaluate the safety, tolerability, and efficacy of HRYZ-T101 injection for HPV18 positive solid tumor. The study will investigate RP2D of HRYZ-T101 TCR-T cell injection.
• 1\. The patient must be willing to sign the informed consent form.
• 2\. Age ≥18 years and ≤75 years.
• 3\. Metastatic or recurrent solid tumors with confirmed HPV18 infection based on TNM \& FIGO staged histopathological investigation. .
• 4\. Subjects who have failed anti-tumor treatment in the past and lack effective treatment options.
• 5\. HPV18 positive and HLA-DRB1\*0901 allele.
• 6\. ECOG performance status ≤1.
• 7\. Estimated life expectancy ≥ 3 months.
• 8\. Patients must have at least one measurable lesion defined by RECIST 1.1.
• 9\. 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≤1.5×ULN; ALT/AST≤3×ULN or ≤5×ULN for liver metastases;
⁃ Creatinine clearance ≥50mL/min; or serum creatinine ≤1.5×ULN;
⁃ INR≤1.5×ULN; APTT≤1.5×ULN;
⁃ LVEF≥50%;
‣ SpO2≥92%.
• 10\. Subjects with potential fertility must agree to use effective contraceptive methods during the whole trials period and at least 1 year after receiving HRYZ-T101 cell transfusion treatment. HCG test for female with potential fertility must be negative within 7 days before apheresis.