γδ T-PD-1 Ab Cells in the Treatment of Advanced Solid Tumors

Inclusion Criteria:

1. The patient voluntarily signs the informed consent and can complete the follow-upexamination, 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, nohematopoietic stimulating factors, no albumin or blood products used within 14 daysprior 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 amountshould be <1g to be allowed to enter the group);

13. The serum pregnancy test of women of childbearing age in the 7 days prior toGamma-delta T-PD-1 Ab infusion is negative, and any fertile male and female subjectmust consent to the use of an effective contraceptive method throughout the studyand 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 childrenand having a normal sex life.

14. A hysterectomy or bilateral oophorectomy has been performed, or ovarian failure hasbeen medically confirmed, or post-menopause has been medically confirmed (menopausefor 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 planplanned for this study;

2. Metastasis of symptomatic central system;

3. Have received other cell therapies, including NK, CIK, DC, CTL, CAR-T, TCR-T, andstem cell therapy in the past 4 weeks;

4. Received systemic steroid therapy (> 10 mg/kg prednisone or equivalent) or any otherform of immunosuppressive medication within two weeks prior to the first dose;Corticosteroids (≤10mg oral prednisone or equivalent) were used in subjects withchronic obstructive pulmonary disease, saline corticosteroids (such ashydrohydrocortisone) were used in subjects with postural hypotension, and low-dosesupplemental 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 otherprimary solid tumor within 6.5 years, unless cured and no evidence of recurrence ofthe disease within 5 years. With the exception of cured basal cell carcinoma of theskin and cervical carcinoma in situ;

7. History of interstitial lung disease, non-infectious pneumonia or uncontrolleddisease, 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 replacementtherapy (such as thyroxine, insulin, or physiologic glucocorticoid replacementtherapy for renal or pituitary insufficiency); Bisphosphonates were administeredwithin 2 months prior to Γδ T-PD-1 Ab infusion.

9. Known subjects had systemic vasculitis, co-active or uncontrolled autoimmunedisease, 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 bythe 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) >5times 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), havea tendency to bleed, or are receiving thrombolytic or anticoagulant therapy.

14. The subject's heart meets any of the following conditions: Left ventricular ejectionfraction (LVEF) ≤45%; New York Heart Association (NYHA) Class III or IV congestiveheart failure; QTcB > 450 msec; Other heart conditions that the investigators judgedunsuitable 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 hematopoieticstimulating factors, such as colony-stimulating factor and erythropoietin, within 2weeks prior to treatment; Major surgical procedures (excluding diagnostic surgicalprocedures) 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 tissueinfection (e.g., fasciitis or osteomyelitis).

18. Participate in other interventional clinical investigators within 3 months prior toinfusion of γδ T-PD-1 AB-PD-1 Ab.

19. A known mental or substance abuse disorder may interfere with the requirement tocooperate in the completion of the trial.

20. Women who are pregnant or breastfeeding, or who plan to become pregnant or havechildren during the study period.

21. In the investigator's judgment, the subject has any serious acute or chronicphysical or mental illness, or laboratory abnormalities that could increase the riskof study participation, study administration, or possibly affect the interpretationof study results.