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.
1. 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.
2. Those who 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.
3. Have received any investigational drug within 4 weeks before apheresis, or have participated in another clinical study at the same time.
4. Have received any cell therapy products before.
Single group
HRYZ-T101 Injection
Biological/VaccineOn day 1, the TCR-T cells will be administered intravenously.
Fludarabine + Cyclophosphamide
DrugFludarabine: 25mg/m²/day×3days; Cyclophosphamide: 250mg/m²/day×3 days
DLT
Dose-limiting toxicity
Adverse events and serious adverse events
Incidence of adverse events and serious adverse events
Objective Response Rate（ORR）
The percentage of subjects with PR or CR assessed by RECIST 1.1.
Disease Control Rate (DCR)
The percentage of subjects with a confirmed CR, PR, or stable disease (SD) assessed by RECIST 1.1.
Duration of response (DoR)
Subjects who show a confirmed CR or PR as assessed by RECIST 1.1.
Time to response (TTR)
Time from date of T-cell administration to first documented evidence of confirmed (CR or PR) as assessed by RECIST 1.1.
Number of Subjects with positive anti-drug antibodies (ADA)
Serum samples will be collected to analyze for the presence of ADAs using validated immunoassays.
Number of subjects with replication competent lentivirus (RCL)
RCL exposure will be assessed by polymerase chain reaction (PCR) based assay.
T cell subgroup in peripheral blood
Collect blood samples and analyze for T cell subgroup by flow cytometry at specified intervals before and after treatment with HRYZ-T101.
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