| Eligibility |
Inclusion Criteria:
1.Age =18 years and =75 years. 2.Failure on or intolerance to systemic therapy for
unresectable advanced cancer.
3.Patients must have at least one measurable lesion defined by RECIST 1.1. 4.Genotype and
tumor antigen screening must meet the following two criteria: 1) HLA-A * 11:01 positive; 2)
KRAS G12V positive 5.ECOG score 0-1 and expected survival time =3 months 6.Patients must
meet the following criteria at screening and before preconditioning (baseline). If any
laboratory test result is abnormal referring to the following criteria, it is acceptable to
test one more time within 1week. If the test result is still abnormal, the patient is
screen failed:
1. Hematology (no intensive blood transfusion (=2 times within 1week), platelet
transfusion or cell growth factor (except for recombinant erythropoietin) performed
within 7days before the test): neutrophils (NE) =1.5×109 per liter, lymphocytes (LY)
=0.5×109per liter (except for before preconditioning), platelets (PLT) =75×109per
liter and hemoglobin (Hb) =8.0 g/dL.
2. Blood chemistry: creatinine clearance =mL/min, alanine aminotransferase (ALT)
=2.5×ULN, aspartate aminotransferase (AST) =2.5×ULN, total bilirubin (TB) =2×ULN,
serum lipase and amylase <1.5 ULN, alkaline phosphatase (ALP) =2.5 ULN; for patients
with bone or hepatic metastasis, AST, ALT and ALP <5ULN.
3. Prothrombin time =ULN+4 seconds. 7.Women of childbearing potential must have negative
serum pregnancy test result at screening and before preconditioning and agree to use
an effective and reliable contraceptive method for at least 1 year after the last
study treatment. Te acceptable methods include bilateral tubal ligation/bilateral
salpingectomy or bilateral tubal occlusion; any approved oral, injection or
implantation of hormone; or barrier contraceptive method: condoms containing
spermicidal foam/gel/film/paste /suppositories or occlusive cap (diaphragm or
cervical/fornix cap).
8.Voluntarily willing to participate in the study and sign the written informed consent.
9.No systemic anti-tumor therapy received within 2 weeks prior to peripheral blood
mononuclear cell (PBMC) collection.
10.Blood oxygen saturation (finger oxygen detection)= 95% in a calm and non oxygenated
state.
Exclusion Criteria:
1. Pregnant or lactating women.
2. HIV, treponema pallidum or HCV serology is positive.
3. Patients with any uncontrolled active infection, including, but not limited to, active
tuberculosis or HBV infection (HBsAg positive or HBV DNA positive).
4. Patients with AEs induced by previous treatment that have not recovered to Common
Terminology Criteria for Adverse Events (CTCAE) =1, except for alopecia and other
tolerable events judged by the investigator or permitted laboratory abnormalities
according to the protocol.
5. Patient allergic or intolerant to preconditioning drugs, including, but not limited
to, fudarabine and cyclophosphamide or oxaliplatin; allergic to the components of
YK0901; penicillin allergy history confrmed by positive skin test; or any severe
allergy history-for example, anaphylactic shock.
6. Patients who have a history of organ transplantation or are waiting for organ
transplantation.
7. Patients who have undergone major surgery or severe trauma within 4weeks before
apheresis .
8. Patients with other serious diseases that may restrict them from participating in this
study, such as poorly controlled diabetes (glycosylated hemoglobin HbA1c >8%
undertreatment), poorly controlled hypertension judged by the investigator (blood
pressure >160mmHg/100mmHg), severe cardiac insufficiency (left ventricular ejection
fraction <50%), myocardial infarction or unstable arrhythmia or unstable angina
pectoris, pulmonary embolism, chronic obstructive pulmonary disease, interstitial lung
disease or clinically significant lung function test abnormalities in the past
6months.
9. Before apheresis and preconditioning, patients who have the following conditions,
including, but not limited to: new-onset arrhythmia that cannot be controlled by
medications; hypotension that requires the use of vasopressors; or bacterial, fungal
or viral infections that require intravenous antibiotic, antiviral or antifungal
treatment, and the investigator judged that they are not suitable to continue the
experiment. Patients who use antibiotics to prevent infection can continue the study
upon the judgment of the investigator
10. Patients who are expected to continue using immunosuppressive therapy during the trial
(excluding physiological replacement therapy with glucocorticoids, such as
prednisone<10mg/d or equivalent doses)
11. Patients with central nervous metastases.
12. Patients who have participated in other intervention clinical trials within 2 weeks.
13. Patients with adverse drug addiction or a history of drug abuse.
14. Patient with other malignant tumors within the past 2 years or at the present, except
for cervical cancer in situ and basal cell carcinoma of the skin.
15. Patients who are unable or unwilling to comply with the clinical protocol, by the
investigator's judgment.
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