| Eligibility |
Inclusion Criteria:
1. Age =18 and =80 years old, gender is not limited;
2. Life expectancy>3 months;
3. The Eastern Oncology Consortium (ECOG) performance status from 0 to 1;
4. Subjects with malignant solid tumors confirmed by pathological diagnosis(who have
failed or unable to tolerate in standard treatment(s), or haven't received standard
treatment),including:
1. Breast cancer: including hormone receptor positive and triple negative breast
cancer;
2. Non-small cell lung cancer, digestive system tumors (esophageal cancer, gastric
cancer, colorectal cancer, pancreatic cancer), urinary system tumors (urothelial
cancer, prostate cancer), gynecological tumors (cervical cancer, endometrial
cancer, ovarian cancer). And the TROP-2 expression rate of tumor tissue in IHC
(immuno-histochemistry) staining is = 50%.
5. The percentage of PD-1positive T lymphocytes in total T lymphocytes is more than 10%,
and subjects should voluntarily receive peripheral blood mononuclear cell (PBMCs)
apheresis collection.
6. At least one or more measurable lesions (CT slice thickness = 5 mm, maximal diameter =
10 mm, and lymph node with malignant metastasis minimal diameter of =15 mm) according
by RECIST 1.1.
7. No serious hematological, hepatic, and renal function abnormalities, adequate function
defined as :
1. Blood system (no blood transfusion or hematopoietic stimulating factor treatment
within 14 days): Neutrophil count (ANC) =1.5×109/L, Platelet (PLT) =75×109/L,
Hemoglobin (Hb) =80g/L, Lymphocyte count (LYM) = 60%×lower limit of normal value;
2. Hepatic function: Total bilirubin (TBIL) =1.5×ULN, Alanine aminotransferase (ALT)
=2.5×ULN,, Aspartate aminotransferase (AST) =5×ULN of patients with liver
metastasis, Creatinine =1.5×ULN or creatinine clearance (eGFR) =60 mL/min
(Cockcroft and Gault formula);
3. Blood coagulation function: Activated partial thrombin time (APTT) =1.5×ULN,
International normalized ratio (INR) =1.5×ULN;
8. Eligible subjects (male or female) must comply with effective contraception methods
(hormonal or barrier method or abstinence, etc.) during the trial period at least 90
days after T60c injection treatment; Female subjects of childbearing potential
(definition refers to appendix) must undergo a pregnancy test (blood or urine) and the
results must be negative within 7 days prior to first use of T60c injection.
9. Subjects must be able to understand the protocol and be willing to enroll the study,
sign the informed consent, and be able to comply with the study and follow-up
procedures.
Exclusion Criteria:
1. Subjects with symptomatic and/or untreated brain metastases (of any size and number);
However, subjects may be eligible if they received documented treatment, and the
intracranial lesion(s) remain stable for at least 2 months before starting screening;
2. Subjects suffered from other malignant tumors within two years prior screen or
concurrent malignancy, except for basal cell skin cancer that has been cured, and in
situ malignancies of cervical carcinoma or lung cancer;
3. Subjects received treatment with tislelizumab (excluding other PD-1 monoclonal
antibodies) or any PD-L1 monoclonal antibody within the first 12 weeks of screening;
4. Subjects received systemic chemotherapy, radiotherapy, immunotherapy and targeted
therapy within 2 weeks before screening; However, the restriction for Nitroso urea or
Mitomycin C are within 6 weeks before screening;
5. Subjects received chronic systemic sex hormone treatment for any reason within 12
weeks before screening; However, the use of low-dose glucocorticoid replacement
therapy due to adrenal cortex dysfunction is exempted.
6. Subjects received granulocyte Colony-stimulating factor (G-CSF) and
Granulocyte-macrophage colony-stimulating factor (GM-CSF) for leukocytosis within 12
weeks before screening;
7. Subjects received with Trop-2-targeted drug treatment previously;
8. Any active autoimmune disease or autoimmune disease in history, which is included but
not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis,
nephritis; and asthma requiring medical intervention by bronchiectasis, etc., except
for vitiligo, psoriasis and alopecia without systemic treatment, well controlled type
I diabetes, hypothyroidism with normal thyroid function after replacement therapy;
9. Recipients of any organ transplant, including allogeneic stem cell transplants, with
exception of transplants requiring no immunosuppression (e.g., corneal transplants,
hair transplants);
10. Subjects with any forms of primary immunodeficiency (e.g., severe combined
immunodeficiency disease (SCID) and acquired immunodeficiency syndrome (AIDS);
11. Presence of major acute or chronic infections, including:
1. Viral hepatitis, including hepatitis B (HBsAg positive and/or hepatitis B DNA
copy number higher than the lower detection threshold of the research center),
Hepatitis C, etc.; HIV antibody test positive; Patients with positive Treponema
pallidum antibodies;
2. Active bacterial or fungal infections that require systemic treatment;
3. Active tuberculosis infection with clinical symptoms, physical examination or
imaging, and laboratory findings;
12. Acute exacerbation of chronic obstructive pulmonary disease or other respiratory
diseases;
13. Cardiovascular/Cerebrovascular disease with clinical significance, such as
cerebrovascular accident/stroke (<6 months before enrollment), myocardial infarction
(<6 months before enrollment), unstable angina, congestive heart failure (= New York
Heart Association Class II) or severe arrhythmia;
14. Clinically uncontrollable serious cavity effusion which is judged by researchers as
unsuitable for inclusion;
15. Subjects received any genetically modified cell therapy in the past;
16. Subjects need anticoagulant treatment (Warfarin or heparin);
17. Subjects need long-term antiplatelet therapy (including but not limited to: aspirin
>300mg/d or clopidogrel >75mg/d, etc.);
18. Pregnant or lactating women;
19. Subjects with no/limited capacity for civil conduction, or mental disorders/ poor
compliance;
20. Alcoholic or drug abuse;
21. Subjects or its families are incapable to understand the content and objectives of
this clinical study;
22. Subjects with other serious or uncontrolled systemic diseases, or other conditions
deemed unsuitable for participation in this clinical trial as judged by the
investigator.
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