an exploratory clinical study of the efficiency and safety of th027 in the treatment of relapsed/refractory solid tumors

Conditions: Solid Tumors

Summary: this is a phase l, open-label, dose-escalation study to evaluate the safety, tolerabilityand antitumor activity of th027 car-t cell lnjection (th-cart-027) in subjects with relapsed or refractory solid tumors.


Eligibility criteria:
inclusion criteria: * 1.the patients were aged from 18 to 75 years old (including the cut-off value), and the gender was not limited; * 2.the expected survival time was more than 12 weeks; * 3.ecog score was 0-2; * 4.one of the following tumor types was confirmed by pathology: osteosarcoma, neuroblastoma, gastric cancer or lung cancer, and the positive rate of cd276 expression in tumor tissue was more than 30% by immunohistochemistry; * 5.patients with ineffective standard treatment methods (such as postoperative recurrence, chemotherapy, radiotherapy, and progression after targeted drugs); * 6.according to recist 1.1, there was at least one measurable lesion (the longest diameter of solid lesion \>=10 mm, or the short diameter of lymph node lesion \>=15 mm); * 7.the function of main organs was normal (white blood cell count \>= 3 × 10\^9 / l, neutrophil count \>= 1.5 × 10\^9 / l, hemoglobin \>= 8.5g/dl, platelet count \>= 80 × 10\^9 / l and lymphocyte count at 1 × 10\^9 / l (including) \~ 4 × 10\^9 / l (inclusive); * 8.the liver and kidney function and cardiopulmonary function meet the following requirements: * urea and serum creatinine \<= 1.5 × uln； * left ventricular ejection fraction \>= 50%; * baseline oxygen saturation \>= 94%; * total bilirubin \<= 1.5 × uln； alt and ast \<= 2.5 × uln； * 9.the patient or legal representative can fully understand the significance and risk of this trial and has signed the informed consent. exclusion criteria: * 1.patients with history of immune deficiency or autoimmune diseases (including but not limited to rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes, etc.); patients with graft-versus-host disease (gvhd) or need immunosuppressive agents; * 2.there was a history of other second malignancies in 5 years before screening; * 3.hepatitis b surface antigen (hbsag) or hepatitis b core antibody (hbcab) were positive, and the peripheral blood hbv dna titer was not within the normal reference value; hcv antibody and hcv rna in peripheral blood were positive; hiv antibody positive patients; syphilis was positive; * 4.severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (nyha classification \>= iii), severe arrhythmia; * 5.unstable systemic diseases judged by researchers: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment; * 6.within 7 days before screening, there were active or uncontrollable infections requiring systemic treatment (except mild urogenital infection and upper respiratory tract infection); * 7.pregnant or lactating women, female subjects who plan to conceive within one year after cell transfusion, or male subjects whose partners plan to conceive within one year after cell transfusion; * 8.patients who had received car-t therapy or other gene modified cell therapy before screening; * 9.the subjects who were receiving systemic steroid treatment within 7 days before the screening or who needed long-term systemic steroid treatment (except inhalation or local use) were determined by the researchers; * 10.the ascites increased gradually after 2 weeks of conservative treatment (such as diuresis, sodium restriction, excluding ascites drainage); * 11.according to the judgment of the researcher, it does not conform to the situation of cell preparation; * 12.other researchers think that it is not suitable for inclusion.