A single center, open, single arm dose escalation phase I study to evaluate the safety, tolerability, and efficacy of HRYZ-T101 TCR-T cell for HPV18 positive advanced solid tumor. The study will investigate DLT of HRYZ-T101 TCR-T cell injection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Fludarabine: 25mg/m²/day×3days; Cyclophosphamide: 250mg/m²/day×3 days
On day 1, the TCR-T cells will be administered one time.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGDLT
Dose-limiting toxicity
Time frame: 28 days
Incidence of treatment related AEs, AEs of special interest and serious adverse events (SAEs).
Assessed by CTCAE V5.0
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
Overall Survival (OS)
From enrollment to death of patients.
Time frame: 2 years
Duration of Response(DOR)
The length of time from the first appearance of a treatment response to the first occurrence of progressive disease or recurrence.
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
Duration of TCR T cells in-vivo persistence
Blood samples were collected to measure persistence of infused HRYZ-T101.
Time frame: Up to 2 years
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