| Eligibility |
Inclusion Criteria:
1. The patient voluntarily signs the informed consent and can complete the follow-up
examination, evaluation and treatment;
2. Age 18-80 years old, gender is not limited;
3. The histopathological diagnosis was malignant solid tumor;
4. Clinical or pathological was stage IV according to AJCC 8th edition stage;
5. Subjects with advanced solid tumors without standard treatment options;
6. ECOG score 0-1;
7. Expected survival =6 months;
8. Have at least one evaluable lesion according to RECIST 1.1 criteria;
9. Organ function level requirements (no blood transfusion or blood products, no
hematopoietic stimulating factors, no albumin or blood products used within 14 days
prior to the first dose);
10. Bone marrow function: absolute value of neutrophils (ANC) =1.5×109, platelets =75×109,
and hemoglobin (Hb) =90g/L;
11. Liver function: total bilirubin =1.5 times the upper limit of normal (ULN); Aspartate
aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 times ULN (5.0 times
ULN if liver metastasis is present), alkaline phosphatase < 5 × ULN;
12. Renal function: serum creatinine level =2 ULN, creatinine clearance > 50mL/min
(according to Cockcroft-Gault formula); Urine protein <2+(If urine protein =2+, urine
protein measurement should be collected for 24 hours, and the total amount should be
<1g to be allowed to enter the group);
13. The serum pregnancy test of women of childbearing age in the 7 days prior to
Gamma-delta T-PD-1 Ab infusion is negative, and any fertile male and female subject
must consent to the use of an effective contraceptive method throughout the study and
for at least 12 weeks after the last study administration. In the researchers'
judgment, a subject is fertile: he/she is biologically capable of having children and
having a normal sex life.
14. A hysterectomy or bilateral oophorectomy has been performed, or ovarian failure has
been medically confirmed, or post-menopause has been medically confirmed (menopause
for at least 12 consecutive months without pathological or physiological causes).
Exclusion Criteria:
1. Intolerance or allergy to any ingredient or similar drug in the treatment plan planned
for this study;
2. Metastasis of symptomatic central system;
3. Have received other cell therapies, including NK, CIK, DC, CTL, CAR-T, TCR-T, and stem
cell therapy in the past 4 weeks;
4. Received systemic steroid therapy (> 10 mg/kg prednisone or equivalent) or any other
form of immunosuppressive medication within two weeks prior to the first dose;
Corticosteroids (=10mg oral prednisone or equivalent) were used in subjects with
chronic obstructive pulmonary disease, saline corticosteroids (such as
hydrohydrocortisone) were used in subjects with postural hypotension, and low-dose
supplemental corticosteroids were used in subjects with adrenal insufficiency.
5. Plan to use any other form of systemic antitumor therapy during the study period;
6. History of known hematological malignancy, primary brain tumor or sarcoma, or other
primary solid tumor within 6.5 years, unless cured and no evidence of recurrence of
the disease within 5 years. With the exception of cured basal cell carcinoma of the
skin and cervical carcinoma in situ;
7. History of interstitial lung disease, non-infectious pneumonia or uncontrolled
disease, including pulmonary fibrosis and acute lung disease;
8. Active autoimmune diseases within the past 2 years requiring systemic treatment (such
as glucocorticoids or immunosuppressive drugs), and related replacement therapy (such
as thyroxine, insulin, or physiologic glucocorticoid replacement therapy for renal or
pituitary insufficiency); Bisphosphonates were administered within 2 months prior to
Gd T-PD-1 Ab infusion.
9. Known subjects had systemic vasculitis, co-active or uncontrolled autoimmune disease,
primary or secondary immune deficiency, graft-versus-host disease (GvHD).
10. Hepatitis B infection, hepatitis C infection, human immunodeficiency virus (HIV)
infection, Treponema pallidum (TP) infection.
11. Had undergone major surgery within 4 weeks prior to screening that was assessed by the
investigator as unsuitable for enrollment.
12. Acute infection and gastrointestinal bleeding occurred in 4 weeks.
13. Major organ dysfunction: absolute value of neutrophils (ANC) < 1.5×109, platelets <
75×109, and hemoglobin (Hb) < 90g/L; Serum albumin < 28g/L, total bilirubin >51µmol/L,
alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times the upper
limit of normal, creatinine > 1.5 times the upper limit of normal; Have abnormal
coagulation function (INR > 1.5 or PT >1.2 ULN or PTT >1.2 ULN), have a tendency to
bleed, or are receiving thrombolytic or anticoagulant therapy.
14. The subject's heart meets any of the following conditions: Left ventricular ejection
fraction (LVEF) =45%; New York Heart Association (NYHA) Class III or IV congestive
heart failure; QTcB > 450 msec; Other heart conditions that the investigators judged
unsuitable for inclusion.
15. People with a history of epilepsy or other active central nervous system diseases.
16. Received live vaccine within 6 weeks prior to screening, and received hematopoietic
stimulating factors, such as colony-stimulating factor and erythropoietin, within 2
weeks prior to treatment; Major surgical procedures (excluding diagnostic surgical
procedures) within 4 weeks before the start of treatment;
17. Evidence of uncontrolled and severe active infection at the time of screening (e.g.,
sepsis, bacteremia, fungemia), or a recent (within 4 months) history of deep tissue
infection (e.g., fasciitis or osteomyelitis).
18. Participate in other interventional clinical investigators within 3 months prior to
infusion of ?d T-PD-1 AB-PD-1 Ab.
19. A known mental or substance abuse disorder may interfere with the requirement to
cooperate in the completion of the trial.
20. Women who are pregnant or breastfeeding, or who plan to become pregnant or have
children during the study period.
21. In the investigator's judgment, the subject has any serious acute or chronic physical
or mental illness, or laboratory abnormalities that could increase the risk of study
participation, study administration, or possibly affect the interpretation of study
results.
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