OncoMatch/Clinical Trials/NCT05952947
HRYZ-T101 Injection for HPV18 Positive Solid Tumor
Is NCT05952947 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05952947 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anti-tumor treatment, cell therapy, investigational drug disqualifies patients from enrollment.
Does this trial require HLA-DRB1?
Yes, HLA-DRB1 *0901 allele is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify