CEA+ Advanced Metastatic Solid Tumor (Colorectal Cancer, stomach cancer, pancreatic cancer and so on)
Conditions
Interventions
Treatment:Inject anti CEA/CD30 CAR T cells
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Patients understand and sign the informed consent form (ICF), and voluntarily participate in clinical study; 2.Patients aged >= 18 and = 1 cycle or longer; Early adjuvant/neoadjuvant therapy is allowed. If tumor relapse and metastasis occur during adjuvant/neoadjuvant therapy or within = 12 weeks; 7.The patient's Eastern Cooperative Oncology Group (ECOG) physical status score must be 0-2; 8.Except for hair loss (any level) and grade 2 peripheral neuropathy, all toxic effects caused by any previous radiotherapy, chemotherapy or surgery must be resolved to = 1.0 x 10^9/L; (2) Hemoglobin >= 80 g/L (without red blood cell transfusion within 14 days); (3) Platelets in patients without bone marrow involvement >= 75 x 10^9/L; (4) Absolute lymphocyte (ALC) >= 0.5 x 10^9/L; 10.Patients with adequate liver function: serum total bilirubin = 60 mL/Min (using Cockcroft Gault formula); 12.Patients with no evidence of difficulty breathing at rest, and the measured pulse oximetry value when breathing room air is > 90%; 13.Patients with sufficient venous access (for apheresis) and no other contraindications to blood cell separation; 14.Women of childbearing age must have a negative serum pregnancy test, and they must agree to take effective contraceptive methods at the same time from the signing of the informed consent form to 6 months after the last administration of the study drug.
Exclusion criteria
Exclusion criteria: 1.Patients received any CAR-T cells product or any other genetically modified T cell therapy in the past; 2.Patients with previous history of allogeneic stem cell or solid organ transplantation or waiting for organ transplantation 3.Acute or uncontrolled active infections, including but not limited to active tuberculosis; 4.Patients with Hepatitis B (positive hepatitis B virus surface antigen and/or positive hepatitis B core antibody and hepatitis B DNA > 10^3 copies/mL) and Hepatitis C (positive hepatitis C antibody test); Patients infected with syphilis, human immunodeficiency virus (HIV positive); 5.Patients with hyponatremia and/or hypokalemia, blood sodium = 50%, or the main portal vein tumor thrombus (occupies >= 50% of the vessel diameter), or the tumor thrombus invades the mesenteric vein/inferior vena cava; 8.There are currently clinically significant pleural effusions and ascites, which are defined as: pleural effusions and ascites that require non-pharmacological intervention (such as puncture) or increased drug intervention to maintain symptom control; 9.Patients who have received continuous systemic steroids (prednisone > 5 mg/day or equivalent doses of other hormones) or other immunosuppressive agents within 14 days before apheresis, except those who have recently or currently used inhaled steroids; 10.Patients received systemic chemotherapy within 2 weeks or 5 half-life before apheresis, or the toxicity of previous anti-tumor therapy has not recovered ( > CTCAE 5.0 grade 1), except for hair loss and pigmentation; 11.Patients received anti-tumor antibody treatments within 4 weeks before apheresis and lymphodepletion; 12.Patients received any previous inhibitory/stimulatory immune checkpoint molecular therapy (anti-PD-1/PD-L1 monoclonal antibody, OX40 agonist, 4-1BB agonist) before apheresis and lymphodepletion, and within 3 half-lives; 13.Patients received immunostimulatory or immunosuppressive therapy (such as IFN-a, IFN-ß, IL-2, etanercept, infliximab, tacrolimus, cyclosporine or mycophenolic acid) within 28 days before apheresis; 14.Patients received short-acting targeted therapy (such as tyrosine kinase inhibitors) before apheresis and within 72 hours before infusion; 15.Patients received radiotherapy within 28 days before apheresis, except for limited local palliative radiotherapy; 16.Patients suffering with other malignant tumors at past or present (except for skin basal cell carcinoma, breast/cervix carcinoma in situ and other malignant tumors that have not been treated and effectively controlled in the past five years); 17.Patients with a history or clinical evidence of primary or metastatic central nervous system (CNS) tumors, including meningeal metastases, are currently asymptomatic, and do not require steroids or enzyme-induced antiepileptic drugs in the last 14 days before screening unless they have previously received treatment for brain metastases; 18.Patients with any other central nervous system disease (such as seizures, cerebral ischemia/hemorrha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Remission Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Duration of Response (DOR);Progression Free Survival (PFS);Overall Survival (OS);Safety; | — |
Countries
China
Contacts
Public ContactZhang Yi
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed