This study is a single center, open, single arm, dose increasing early clinical study. The purpose of this study is to evaluate the safety and efficacy of YK0901 immunotherapy in the treatment of patients with advanced solid tumor whose tumor antigen KRAS G12V expression is positive (HLA-A \* 11:01).
KRAS mutations exist in various cancers, especially pancreatic, lung and colorectal cancer. G12V is one of the most common mutation types for KRAS. It's challenging to chemically acquire the targeted drug for this mutation. Recent studies reported that this mutation peptides can form a neoepitope for T cell recognition.Our study aims to evaluate the safety and tolerability of YK0901 TCR-T cell for KRAS G12V positive advanced solid tumors.In this trial, 11 subjects with KRAS G12V mutations and matching HLA-A\*11:01 subtypes are recruited for autologous TCR-T therapy.Within 1-7days after pretreatment, subjects will receive a single TCR-T infusion with an infusion dose of about 1×108~5×1010.Once every 12 hours within 24 hours after TCR-T cell infusion, recombinant human interleukin-2 will be injected intravenously for 14 days .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
On day 0, the TCR-T cells will be administered one time. Drug: Fludarabine + Cyclophosphamide+Oxaliplatin Fludarabine: 25mg/m²/day×3days Cyclophosphamide: 300mg/m²/day×3 days Oxaliplatin:100mg×1day Drug: IL-2 After 18-24 hours of infusion of YK0901 cells, the patients will be given a small dose of IL-2 subcutaneously, 500,000 IU/time, twice a day (interval 10-12 hours), for 14 days.
Department of GI Oncology, Peking University Cancer Hospital
Beijing, China
Dose-limiting toxicity (DLT)
Time frame: 2 years
Treatment related AEs
Time frame: 2 years
Antitumor efficacy-Objective response rate (ORR)
The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%).
Time frame: 2 years
Antitumor efficacy-Progression-free survival (PFS)
The period from the day when the subject receives the infusion of cells to the first recorded tumor progression (whether treated or not) or death of any cause, which occurs first.
Time frame: 2 years
Antitumor efficacy-Overall survival (OS)
The period from the first infusion to any cause of death
Time frame: 2 years
Antitumor efficacy-Duration of response (DOR)
The period from the first evaluation of CR or PR to the first evaluation of PD or death of any cause
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.