NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors

Inclusion Criteria

• •1. Age ≥18, male \& female;
• •2. Patients with recurrent/refractory NKG2DL+ tumors diagnosis by pathological histology or cytology, focus on the inclusion of patients with hepatocellular carcinoma positive. (If recruit liver cancer patients, patients should with locally advanced or metastatic hepatocellular carcinoma (HCC), Barcelona clinic liver cancer (BCLC) staging system classification for B or C, for B, patients are not suitable for local treatment and/or surgery, or disease progression occurs after surgery and/or local treatment, or declined to surgery and/or local treatment);
• •3. Patients who fail first-line treatment or are unwilling to receive first-line treatment;
• •4. Disease progression occurred within 14 days before inclusion (RECIST criteria must be used as a basis for assessment of disease progression). According to RECIST V1.1, patients have at least one measurable lesion. Target lesions located within the field of previous therapeutic irradiation or within the area of local treatment (interventional or ablative treatment) are considered measurable if progress is confirmed;
• •5. The main organs function normally and meet the following requirements;
• •Blood routine examination shall be in accordance with (no blood transfusion within 14 days) :
• •1. HB≥90g/L
• •2. ANC ≥1.5×10\^9/L
• •3. PLT ≥75×10\^9/L
• •serum biochemicals examination shall be in accordance with:
• •1. BIL \<1.5 upper normal limit (ULN)
• •2. ALT and AST\<2.5×ULN; In the case of liver metastasis, ALT and AST\<5×ULN
• •3. Serum Cr≤1×ULN, endogenous creatinine clearance≥50ml/min(Cockcroft-Gault formula)；
• •6. ECOG physical condition score: 0-1;
• •7. Expected survival time ≥3 months;
• •8. Cardiac function well before inclusion, no myocardial infarction attack occurred within half a year, and hypertension and other coronary heart disease were under control at present;
• •9. No other uncontrollable benign diseases such as lung, kidney, liver infection before enrollment;
• •10. Women of childbearing age must undergo a negative pregnancy test (serum or urine) within 7 days of enrollment and voluntarily use an appropriate method of contraception during observation and within 8 weeks after the last administration; men should be surgically sterilized or agree to use an appropriate method of contraception during the observation period and within 8 weeks after the last administration;
• •11. Patients voluntarily participated in this trial and sign the informed consent form;
• •12. Patients with compliance and expected to follow up the efficacy and adverse reactions as required by the protocol；
• •13. CAR-T cells amplify successfully to the expected number.