Safety and Efficacy of CCT301 CAR-T in Adult Subjects With Recurrent or Refractory Stage IV Renal Cell Carcinoma

Inclusion Criteria:

1. Men or women aged 18~70 years old.

2. Patients are diagnosed as refractory / recurrent, Stage IV renal cell carcinoma byhistological method with FDG PET signal > 3 SUV in measurable metastatic lesion.

3. Patients with at least two metastatic lesions, including one measurable metastatictumor lesion >10 mm measurable by CT.

4. Tumor tissues samples confirmed CCT301 target positive IHC. Patient withhistological biopsy.

• tumor tissue with greater than or equal to 50% positive staining by IHC methodfor ROR2 ;

• tumor tissue with greater than or equal to 50% positive staining by IHC methodfor AXL that is ROR2 negative.

5. Expected survival ≥12 weeks.

6. ECOG 0-1

7. Adequate organ function as documented by:

• ANC≥1.9X10^9/L

• PLT≥100x10^9/L

• Hb≥9.0g/dL

• rCCR≥50ml/min

• ALT and AST≤2.5ULN; for liver metastasis, ALT and AST ≤5ULN

• Serum TBiL≤3.0mg/dL, TBiL≤2.5ULN

8. PT: INR < 1.7 or extended PT to normal value < 4s

9. Adequate venous access for venous blood collection, and no other contraindication ofblood cell separation

10. Patients with willingness to be in this study and able to provide informed consent

11. Capable of receiving treatment and follow up, included patients are required toreceive treatment in the enrolled centre

12. Women of childbearing age are required to take acceptable measures to minimize thepossibility of pregnancy during whole session. Women of childbearing age must havenegative results of serum or urine tests within 24 hours prior to infusion. Womenpatients must not be in lactation;

13. Immunological detection

Exclusion Criteria:

14. Pregnant women or women in lactation.

15. Active HBV or HCV infection.

16. HIV/AIDS infection.

17. Active infection

18. Previously suffered from diseases or concurrent diseases as follows:

19. Patients confirmed as severe autoimmune diseases in long-term (over 2 months) needof systemic immune inhibitors (steroid) or as immune-mediated symptomatic diseasesincluding ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupuserythematosus (SLE), autoimmune vasculitis (for example, Wegener's granulomatosis)

20. Patients with previous diagnosis as motor neuron disease caused by autoimmunity

21. Patients previously suffered from toxic epidermal necrolysis (TEN)

22. Patients with any mental diseases including dementia, mental status change that mayimpinge the understanding and performance of informed consent and relatedquestionnaire

23. Patients with severe, uncontrollable diseases judged by investigator that may hinderthem receiving this treatment

24. Patients with other previously active malignant tumors including basal or squamousskin cancer, superficial bladder cancer, and in situ breast carcinoma within 5 yearswho had been completely cured without the need of follow-up treatment are notexcluded.

25. Ongoing treatment using systemic steroid or steroid inhalants.

26. Previous treatment used gene/cell therapy products.

27. Previous experience of immunotherapies including CIK, DC, DC-CIK, LAK for thetreatment of cancer.

28. Allergic to immunotherapies or related drugs

29. Patients in need of treatment for heart failure with ≥2 NYHA or for poor controlledhypertension.

30. Patients with unstable or active peptic ulcer or alimentary tract hemorrhage.

31. Patients with previous organ transplantation or ready for organ transplantation.

32. Patients in need of anticoagulant therapy treatment (warfarin or heparin)

33. Patients judged by investigators as not appropriate for this study.