Overview

This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC729 in the treatment of advanced malignant solid tumors.

Condition or disease:advanced malignant solid tumors. Intervention/treatment:Biological: CD70 CAR-NKT cells. Phase:I

Eligibility

Inclusion Criteria:

• Age 18 to 75 years.
• ECOG 0-1 points.
• The expected survival time is more than 3 months.
• Patients with advanced advanced malignant solid tumor confirmed by histology or cytology to be recurrent or metastatic after at least second-line treatment.
• IHC: CD70 positive.
• At least one measurable lesion at baseline per RECIST version 1.1.
• The functions of important organs are basically normal:Hematopoietic function:

        neutrophils 1.5×109/L, platelets 75×109/L, hemoglobin 80g/L;Renal function: creatinine
        clearance of ≥60 mL/min.;Liver function: ALT and AST ≤2.5×ULN (≤5 × ULN for patients with
        liver metastases);Total bilirubin ≤1.5×ULN.Prothrombin time (PT) : INR < 1.7.
          -  Pregnancy tests for women of childbearing age shall be negative, Both men and women
             agreed to use effective contraception.
          -  Subjects or their guardians agree to participate in this clinical trial and sign the
             ICF, indicating that they understand the purpose and procedures of this clinical trial
             and are willing to participate in the research.
        Exclusion Criteria:
          -  Use of cell therapy within the previous one month.
          -  Risk of severe bleeding in esophageal cancer
          -  Subjects with other malignant tumors within the past 2 years, except basal or squamous
             skin cancer, superficial bladder cancer, and breast cancer in situ, have been
             completely cured and do not need follow-up treatment.
          -  Patients with leptomeningeal metastasis or central nervous system metastasis, and
             definite central nervous system underlying diseases with significant symptoms in the
             past 6 months.
          -  Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2
             weeks before cell infusion.
          -  Active hepatitis B, HIV positive and HCV positive
          -  Active infection or uncontrollable infection.
          -  Subjects with NYHA heart failure class ≥2 or hypertension uncontrolled by standard
             therapy requiring special treatment, previous history of myocarditis, or myocardial
             infarction within 6 months.
          -  Unstable respiratory diseases, including interstitial pneumonia.
          -  Uncontrolled ascites and pleural effusion
          -  Known to have active or uncontrolled autoimmune diseases, such as Crohns disease,
             rheumatoid arthritis, systemic lupus erythematosus, etc. .
          -  Subjects who are using systemic steroids or steroid inhalers for treatment.
          -  Pregnant or lactating female subjects.
          -  Other investigators deem it unsuitable to participate in the study.