| Eligibility |
Inclusion Criteria:
1. Voluntarily sign a written informed consent.
2. Age =18 years old, =70 years old, male and female.
3. Expected survival = 3 months.
4. The Eastern Cancer Collaboration (ECOG) physical fitness score was 0-1.
5. Biopsy specimen or pathological wax section test (within 3 years before the signing of
informed consent): Target protein test is positive.
6. At least one measurable lesion according to RECIST v1.1 solid tumor evaluation
criteria.
7. Patients with recurrent/metastatic refractory digestive tract tumors (esophageal,
gastric, pancreatic, or colorectal cancer) who have previously received second-line or
above standard treatment failure or intolerance.
8. It is possible to establish a vein access for simple or intravenous blood collection,
and there are no other contraindications for blood cell separation.
9. having adequate organ and bone marrow function, as defined below: Blood routine
examination Neutrophil count (NEU #) =1.0×10^9/L Platelet count (PLT) =80×10^9/L
Hemoglobin concentration =90g/L Liver function: subjects without liver metastases
Aspartate aminotransferase (AST) =2.5× Upper Limit of Normal (ULN) Alanine
aminotransferase (ALT) =2.5× Upper Limit of Normal (ULN) Total bilirubin (TBIL)
=1.5×ULN Liver function: Subjects with liver metastases Aspartate aminotransferase
(AST) =5× Upper limit of normal (ULN) Alanine aminotransferase (ALT) =5× Upper limit
of normal (ULN) Liver function: Subjects with liver metastases or Gilbert syndrome
Total bilirubin (TBIL) =2×ULN renal function Creatinine clearance (CCR) =50 mL/min
Coagulation function International Standardized ratio (INR) =1.5×ULN Activated partial
thromboplastin time (APTT) =1.5×ULN
10. Toxic side effects left over from previous anti-tumor therapy (radiotherapy,
chemotherapy, targeted therapy, etc.) = grade 1 (CTCAE 5.0).
11. During the study period and for 6 months after the end of dosing, fertile subjects
(both male and female) must use effective medical contraception. For female subjects
of reproductive age, a pregnancy test should be performed within 72 hours before the
first dose and the result are negative.
Exclusion Criteria:
1. Active central nervous system metastases (except those stable after treatment).
2. HIV positive, HBsAg positive, HBV DNA copy number positive (quantitative detection
=1000cps/ml), HCV antibody positive and HCV RNA positive.
3. Patients with mental or mental illness who cannot cooperate with treatment and
efficacy evaluation.
4. Subjects with severe autoimmune diseases and long-term use of immunosuppressants.
5. Active or uncontrolled infections requiring systemic treatment during the 14 days
prior to enrollment.
6. Any unstable systemic disease (including but not limited to):
Active infections (except local infections); unstable angina pectoris; cerebral
ischemia or cerebrovascular accident (within 6 months prior to screening); myocardial
infarction (within 6 months before screening); Congestive heart failure (New York
Heart Association [NYHA] classification =III); Severe arrhythmias requiring medical
treatment; have a heart condition that requires treatment or uncontrolled hypertension
after treatment (blood pressure > 160mmHg/100 mmHg).
7. dysfunction of important organs such as lung, brain and kidney.
8. The subject has undergone major surgery or severe trauma within 4 weeks prior to
receiving cell therapy or is expected to undergo major surgery during the study
period.
9. Received any systemic chemotherapy, immunotherapy, or small molecule targeted therapy
within 1-2 weeks prior to an apheresis or within 5 half-lives, whichever is shorter.
10. The subject currently has or has had other malignant tumors that cannot be cured
within 3 years, except cervical carcinoma in situ or basal cell carcinoma of the skin,
and other malignant tumors with disease-free survival of more than 5 years.
11. Received chimeric antigen receptor modified T cells (including CAR-T, TCR-T) within
six months.
12. Graft-versus-host disease (GVHD).
13. Participants who were receiving systemic steroid therapy prior to screening and who
were determined by the investigator to require long-term use of systemic steroid
therapy during treatment (except for inhalation or topical use); And subjects treated
with systemic steroids within 72 h prior to cell transfusion (except for inhalation or
topical use).
14. Severe allergies or history of allergies.
15. Subjects requiring anticoagulation therapy.
16. Pregnant or breastfeeding women, or have a pregnancy plan within six months (for both
men and women)
17. Researchers believe that there are other reasons for not being included in the
treatment.
|
