OncoMatch/Clinical Trials/NCT05952947
HRYZ-T101 Injection for HPV18 Positive Solid Tumor
Is NCT05952947 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including HRYZ-T101 and Fludarabine + Cyclophosphamide for cervical cancer.
Treatment: HRYZ-T101 · Fludarabine + Cyclophosphamide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cervical Cancer
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HLA-DRB1 *0901 allele
HLA-DRB1*0901 allele
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-tumor treatment
Subjects who have failed anti-tumor treatment in the past and lack effective treatment options.
Cannot have received: systemic anti-tumor treatment (conventional chemotherapy, large-area radiotherapy, targeted therapy, immunotherapy, biological therapy, other anti-tumor treatment, small molecule targeted drugs, oral fluorouracils, Chinese herbal medicine)
Have undergone systemic anti-tumor treatment within 4 weeks before apheresis, including who have received conventional chemotherapy, large-area radiotherapy, targeted therapy, immunotherapy or biological therapy, and other anti-tumor treatment. Have received small molecule targeted drugs and oral fluorouracils or Chinese herbal medicine within 2 weeks before apheresis.
Cannot have received: cell therapy
Have received any cell therapy products before.
Cannot have received: investigational drug
Have received any investigational drug within 4 weeks before apheresis, or have participated in another clinical study at the same time.
Lab requirements
Blood counts
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
Kidney function
Creatinine clearance ≥50mL/min; or serum creatinine ≤1.5×ULN
Liver function
total bilirubin≤1.5×ULN; ALT/AST≤3×ULN or ≤5×ULN for liver metastases
Cardiac function
LVEF≥50%; SpO2≥92%
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%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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