CELL INTELLIGENCE · 肿瘤细胞治疗研究

Inclusion Criteria:

1. Male or female patients aged from 18 to 70 years old;
2. The patient's ECOG score is ≤ 2;
3. Patients with advanced or metastatic renal cell carcinoma:

(1) have received first-line and second-line targeted therapy in the past; (2) Previous immunization with PD-1/L1 and ≤2 regimens; (3) Unable to tolerate targeted therapy or immunotherapy. 4.There are measurable or evaluable lesions; 5.The main tissues and organs of patients function well:

1. liver function: ALT/AST\< 3 times the upper limit of normal value (ULN);
2. Renal function: creatinine \< 220 μmol/L;
3. Lung function: indoor oxygen saturation ≥ 95%;
4. Cardiac function: Left ventricular ejection fraction (LVEF)≥40% 6.Patients or their legal guardians voluntarily participate and sign informed consent.

Exclusion Criteria:

1. Infectious diseases (such as HIV, active hepatitis B or C infection, active tuberculosis, etc.);
2. Feasibility assessment and screening showed that the transfection of targeted lymphocytes was less than 10% or the amplification was insufficient (\< 5 times) under the co-stimulation of CD3/CD28.
3. The vital signs are abnormal, and those who cannot cooperate with the examination;
4. Those who have mental or psychological diseases can not cooperate with treatment and efficacy evaluation;
5. Highly allergic constitution or severe allergic history, especially those who are allergic to IL-2;
6. Subjects with systemic infection or severe local infection who need anti-infection treatment;
7. Complicated with dysfunction of heart, lung, brain, liver, kidney and other important organs;
8. Patients with other tumors;
9. Doctors believe that there are other reasons that can not be included in the treatment.

主要终点：Safety evaluation:Incidence and severity of adverse events · To evaluate the incidence and severity of possible adverse events within one month after targeted CAIX CAR-T infusion, including cytokine release syndrome and on-target toxicity. · First 1 month after CAR-T cells infusion；Effectiveness evaluation · In order to observe the efficacy of CAR-T cells after infusion, total remission rate (ORR), complete remission (CR), partial remission (PR), disease stability (SD) or progression (PD) will be used for evaluation. · 3 months after CAR-T cells infusion
次要终点：Progression-free survival (PFS)；Overall survival (OS)

• CAR-T cell immunotherapy · EXPERIMENTAL · The registered patients will received CAR-T cell immunotherapy for the new specific chimeric antigen receptor of CAIX antigen by infusion.

This is an experimental study to evaluate the safety and efficacy of CAR T cells targeting CAIX in the treatment of advanced renal cancer.