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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
On day 1, the TCR-T cells will be administered intravenously.
Fludarabine: 25mg/m²/day×3days; Cyclophosphamide: 250mg/m²/day×3 days
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGDLT
Dose-limiting toxicity
Time frame: 28 days
Adverse events and serious adverse events
Incidence of adverse events and serious adverse events
Time frame: 2 years
Objective Response Rate(ORR)
The percentage of subjects with PR or CR assessed by RECIST 1.1.
Time frame: 2 years
Disease Control Rate (DCR)
The percentage of subjects with a confirmed CR, PR, or stable disease (SD) assessed by RECIST 1.1.
Time frame: 2 years
Duration of response (DoR)
Subjects who show a confirmed CR or PR as assessed by RECIST 1.1.
Time frame: 2 years
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.
Time frame: 2 years
Progression-Free Survival(PFS)
The length of time from enrollment until the time of progression of disease.
Time frame: 2 years
Overall Survival (OS)
The interval of time between the date of T-cell infusion and the date of death.
Time frame: 2 years
Duration of TCR T cells in-vivo persistence
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Blood samples were collected to measure persistence of infused HRYZ-T101.
Time frame: 2 years
Concentration of Cytokines (IL-2、IL-6、IL-10、TNFα、IFNγ)
Collect blood samples and analyze for presence of cytokines (IL-2、IL-6、IL-10、TNFα、IFNγ) at specified intervals before and after treatment with HRYZ-T101.
Time frame: 2 years