Malignant melanoma, lung or colorectal cancer
Conditions
Interventions
Experimental group:TAA06 Cells for Infusion
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years (including the threshold value), gender is not limited; 2. The expected survival time exceeds 12 weeks; 3. ECOG score 0-2 points; 4. Pathologically diagnosed as any of the following tumor types: malignant melanoma, lung cancer or colorectal cancer, and the positive rate of TAA06 expression in tumor tissue by immunohistochemical detection is >=1%; 5. Patients with ineffective standard treatment (eg: recurrence after surgery, progression after chemotherapy, radiotherapy, targeted drugs); 6. According to the efficacy evaluation criteria for solid tumors (RECIST 1.1), at least one measurable lesion (the longest diameter of solid lesions >=10mm, or the short diameter of lymph node lesions >=15mm); 7. Normal function of major organs: (white blood cell count >=3x10^9/L, neutrophil count >=1.5x10^9/L, hemoglobin >=8.5g/dL, platelet count >= 80x10^9/L, lymphocyte count between 1x10^9/L (inclusive)-4x10^9/L (inclusive)); 8. Liver and kidney function, cardiopulmonary function meet the following requirements: (1) Urea and serum creatinine=50%; (3) Baseline blood oxygen saturation >= 94%; (4) Total bilirubin<=1.5xULN; ALT and AST<=2.5xULN; 9. The patient himself or his legal representative can fully understand the significance and risks of this trial and has signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of immunodeficiency or autoimmune diseases (including but not limited to rheumatoid joint disease, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes, etc.); patients with graft-versus-host disease (GVHD) or need to use immunosuppressants; 2. There is a history of other second malignant tumors within 5 years before screening; 3. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer quantitative detection is not within the normal reference range; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis positive; 4. Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association [NYHA] classification >= grade III), severe arrhythmia; 5. Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment; 6. Within 7 days before screening, there is active infection or uncontrollable infection requiring systemic treatment (except mild urogenital infection and upper respiratory tract infection); 7. Pregnant or lactating patients, and female patients who plan to become pregnant within 1 year after cell reinfusion or male patients whose partners plan to become pregnant within 1 year after cell reinfusion; 8. Received CAR-T therapy or other gene-modified cell therapy before screening; 9. Patients who are receiving systemic steroid therapy within 7 days before screening or who are judged by the investigator to require long-term use of systemic steroid therapy during treatment (except inhalation or topical use); 10. With more than moderate amount of ascites, or after conservative medical treatment (such as diuresis, sodium restriction, excluding drainage of ascites) for 2 weeks, the ascites still shows a progressive increase; 11. According to the judgment of the researcher, it does not meet the situation of cell preparation; 12. Other researchers think that it is not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness; | — |
Countries
China
Contacts
Public ContactWang Zhiyu
Outcome results
None listed