CCT301-38 CAR-T in Patients With Relapsed or Refractory AXL Positive Sarcomas

Inclusion Criteria:

1. Patients with willingness to be in the study and follow all study procedures, andcapable of providing informed consent

2. Male or female aged 18-70 years;

3. Patients with unresectable, locally advanced or metastatic relapse/refractorysarcomas that have failed at least the front line standard treatment confirmed byhistology or cytology;

4. At least one measurable lesion, i.e. the length of non-lymph node lesions examinedaccording to CT cross-sectional scanning or magnetic resonance imaging (MRI), or theshort diameter of the lymph node lesions is ≥15 mm according to RECIST 1.1, and theFDG PET signal from the measurable lesion is > 3 SUV;

5. Tumors with AXL positive (IHC 1+ or greater) in ≥50% of all tumor cells. A newbiopsy is required if the sample is over one year.

6. ECOG Performance Status 0-1;

7. Expected survival greater than 12 weeks;

8. Adequate organ and hematopoietic system functions to meet the followingrequirements:

• Hemoglobin (HGB) s 90 g/L, no blood transfusions within two weeks;

• White blood cell (WBC) count≥2.5×109/L；

• Absolute Neutrophil Count (ANC) ≥1.5×109/L;

• Platelet (PLT) count ≥80×109/L;

• Total bilirubin (TBIL) ≤3.0ng/dL or ≤5 ULN;

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

• Creatinine (Cr) ≤1.5 x ULN; or creatinine removal rate (CrCl) ≥50 mL/min;

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

10. Normal language, recognition and consciousness assessed by investigator duringscreening phase;

11. Capable of receiving treatment and follow-up, including treatment in the clinicalcenter;

Exclusion Criteria:

1. Females with pregnancy or in lactation period;

2. Subjects with active hepatitis B, or active hepatitis C. Subjects with undetectableHBV DNA or HCV RNA after anti-virus treatment can be enrolled;

3. HIV positive;

4. Other active infections of clinical significance;

5. Subjects with the following previous or accompanying diseases:

• Subjects diagnosed as severe autoimmune diseases that require long term (more than 2 months) treatment with systemic immunosuppressants (steroids), or diseases withimmune-mediated symptoms, including ulcerative colitis, Crohn's disease, rheumatoidarthritis, systemic lupus erythematosus (SLE), and autoimmune vasculitis (e.g.Wegena granuloma);

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

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

8. Patients with any mental illness, including dementia, mental changes, which maycause difficulties understanding the informed consent and related questionnaires;

9. Patients with serious uncontrollable diseases, which may interfere with thetherapies in this study;

10. Patients with other active malignancies in the past 5 years excluding those withcompletely cured basal or squamous skin cancers, superficial bladder cancers orprimary breast cancers without need of follow-up treatment;

11. Subjects receiving systemic steroids or steroid inhalants;

12. Patients who have received tumor immunotherapy (including monoclonal antibodyagainst PD-1, PD-L1, PD-L2, CD137 or CTLA-4, or cell therapy) in the past 4 weeks;

13. Subjects allergic to immunotherapies or related drugs;

14. Patients with metastatic lesions in meninges or central nervous system, or clearevidence of central nervous system diseases with continuous significant symptoms inthe last 6 months;

15. Patients with NYHA class II heart failure, or hypertension incontrollable bystandard care, or medical history of myocarditis, or heart attack within a year;

16. Subjects who have received or are going to receive organ transplantation;

17. Patients with active bleeding;

18. Patients with incontrollable pleural or abdominal fluid that needs clinicaltreatment or intervention;

19. Patients as determined by the investigators to be inappropriate for the study.