| Eligibility |
Inclusion Criteria:
1. Greater than or equal to 18 years of age and less than or equal to 75 years of age;
all genders.
2. Advanced solid tumors including but not limited to some high frequency somatic
mutations,such as melanoma,driver mutation-negative non-small cell lung cancer.
3. Advanced solid tumors patients who are HLA - A0201 /A1101/A2402 subtypes.
4. Measurable solid tumors with at least one lesion that is resectable or tumor biopsies
for DNA extraction.
5. Patients who failed or were intolerant to standard treatment.
6. Possess venous access for mononuclear cell collection or intravenous blood collection.
7. Patients (or their legal representatives) who are able to understand and sign the
Informed Consent Form and willing to sign a durable power of attorney.
8. Clinical performance status of ECOG is 0 or 1.
9. Patients who are able to cooperate to observe adverse reactions and the effect of the
treatment,expected lifetime is greater than six month.
10. Patients of both genders must be willing to practice birth control from the time of
enrollment to three months after treatment on this study,a fertile woman must have a
negative pregnancy test.
11. The laboratory test values and the functions of important organs meet the following
requirements:1)Serology: HIV antibody(-), hepatitis B DNA(-), hepatitis C antibody(-)
and no active syphilis infection; 2)Hematology: Absolute neutrophil count is greater
than or equal to 1.5×10^9/L; WBC is greater than or equal to 3×10^9/L; lymphocyte
count is greater than or equal to 0.8×10^9/L; Platelet count is greater than or equal
to 80×10^9/L; Hemoglobin is greater than or equal to 90g/L ; 3)Chemistry: Serum
ALT/AST is less than or equal to 3 times ULN,except in patients with liver metastasis
who must have ALT/AST less than or equal to 5 times ULN; Serum Creatinine is less than
or equal to 1.5 times ULN ; Total bilirubin is less than or equal to 1.5 times ULN,
except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3
times ULN;4)Blood Clotting Parameters:Prothrombin Time(PT) and International
Normalised Ratio (INR) are less than or equal to 1.5 times ULN;Activated Partial
Thromboplastin Time (APTT) is less than or equal to 1.5 times ULN;For subjects who
frequently take anticoagulant drugs,their blood clotting parameters can meet the value
range adptive to this special population;5)Left ventricular ejection fraction(LVEF)is
more than or equal to 50%.
12. More than four weeks must have elapsed since any prior systemic therapy at the time
the patient receives the lymphodepletion regimen, and toxicities must have recovered
to grade 1 or less (except for toxicities such as alopecia or vitiligo).
Exclusion Criteria:
1. Pregnant or lactating women.
2. History of severe immediate hypersensitivity reaction to Neo-T and any of the agents
used in this study.
3. Subjects with a history of organ transplantation.
4. Subjects with unstable brain metastases.
5. Any active autoimmune disease or subjects with a history of autoimmune diseases that
have been assessed by the investigator to be unsuitable for this study.Including but
not limited to the following diseases: such as systemic lupus erythematosus, immune
related neuropathy, multiple sclerosis, Guillain Barre syndrome, myasthenia gravis,
connective tissue diseases, inflammatory bowel diseases(Crohn's disease and ulcerative
colitis), excluding vitiligo, eczema, type I diabetes, rheumatoid arthritis and other
joint diseases, Sjogren's syndrome and controlled psoriasis by local medication.
6. Active systemic infections,for example, acute infections requiring systemic
antibiotic, antiviral, or antifungal treatment occur within 2 weeks before enrollment.
7. Severe liver and kidney function damage(gived treatment is still uncontrollable,and
biochemical indicators cannot meet the Exclusion Criteria of 11th), uncontrollable
diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or poorly
controlled hypertension (systolic pressure>160mmHg and/or diastolic pressure>90mmHg);
active cardiovascular and cerebrovascular diseases, such as acute stroke,myocardial
infarction,unstable angina,congestive heart failure rated as Grade II or above by the
New York Heart Association, severe cardiac arrhythmias that cannot be controlled with
medication,electrocardiograms show significant abnormalities (three consecutive times
with an interval of at least 5 minutes) which have been assessed by the investigator
that affect subsequent cellular treatment; mental illness and drug abuse, or any
situation that the investigator assessments may increase the risk of this study.
8. Subjects plan to receive glucocorticoid(the dose of prednisone or alternative drug is
more than 10mg per day) or other immunosuppressant within 4 weeks before the
administration of lymphocyte clearance.Tips: when there is no active autoimmune
disease, it is allowed to use prednisone or alternative drug with a dose less than 10
mg per day; Allowing subjects to use topical, ocular, intra articular, intranasal, and
inhaled glucocorticoids for treatment.
9. Subjects plan to receive immunomodulatory drugs (such as interferon, GM-CSF, thymosin,
gamma globulin, excluding IL-2) within 4 weeks before the administration of lymphocyte
clearance.
10. The investigator assessed that the subject was unable or unwilling to comply with the
requirements of the study protocol.
11. The genes correlated to functional defects in antigen presentation, antigen
recognition, and cell killing have been detected.
12. With a history of other malignant tumors within the past 5 years; Excluding basal cell
carcinoma, thyroid papillary carcinoma, cervical carcinoma in situ, or breast ductal
carcinoma in situ.
13. The subject has any disease or medical condition that may affect the safety or
effectiveness evaluation of the study treatment.
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