CEA+ Advanced Metastatic Solid Tumor
Conditions
Interventions
Treatment group:Infusion of anti-CEA/CD30 CAR T cells
Sponsors
Hubei Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Understand and sign the informed consent form and voluntarily participate in clinical research; 2. Aged 18-70 years, gender is not limited; 3. Subjects with locally advanced and/or metastatic solid tumors with cytoplasmic and/or membranous high CEA expression in tumor tissue are required (participants without detectable archived tumor tissue must have biopsiable lesions) ; 4. The subjects is in a tumor recurrence or tumor persistent/refractory state, and has received at least 2 or more lines of systemic standard therapy (SOC) before with disease progression, is intolerant to SOC, or is not adapted to SOC; It is difficult to accept standard (treatment intent) surgery and radiotherapy, and there is currently no effective treatment. Advanced/metastatic pancreatic cancer with no indication for surgery/postoperative recurrence, pancreatic cancer patients who failed the first-line standard treatment or refused standard treatment, can be enrolled in this trial; Definition of Treatment Failure: (1) Disease progression during treatment or tumor recurrence and metastasis after treatment, or intolerable toxicity; (2) Each line of treatment for advanced disease includes one or more chemotherapy drugs for >=1 cycle or longer; early adjuvant/neoadjuvant therapy is allowed. If tumor recurrence and metastasis occur during adjuvant/neoadjuvant therapy or within = 12 weeks; 7. The patient's Eastern Cooperative Oncology Group (ECOG) performance status score must be 0-2; 8. All types of toxic effects from any prior radiotherapy, chemotherapy, or surgery, except alopecia (any grade) and grade 2 peripheral neuropathy, must resolve to = 1.0 x 10^9/L; (2) Hemoglobin >= 80 g/L (without red blood cell transfusion within 14 days); (3) Platelets >= 75 x 10^9/L; (4) Absolute lymphocytes (ALC) >= 0.5 x 10^9/L; 10. Sufficient liver function: serum total bilirubin = 60 mL/Min (using Cockcroft Gault formula); 12. There is no evidence that the subject has difficulty breathing at rest, and the measured value of the pulse blood sample when breathing room air is > 90%; 13. Have sufficient venous access (for apheresis), and no other contraindications for blood cell separation; 14. The serum pregnancy test for women of childbearing age must be negative. All subjects must agree to take effective contraceptive methods at the same time from signing the informed consent to 6 months after the last dose of the study drug.
Exclusion criteria
Exclusion criteria: 1. Those who have previously used any CAR-T cell product or other genetically modified T cell therapy; 2. Patients who have a history of allogeneic stem cell or solid organ transplantation or are waiting for organ transplantation; 3. Acute or uncontrolled active infection, including but not limited to active tuberculosis; 4. Hepatitis B (positive for hepatitis B virus surface antigen and/or positive for hepatitis B core antibody and hepatitis B DNA >10^3 copies/mL) and hepatitis C (positive for hepatitis C antibody test); syphilis, human immunodeficiency (HIV) infection (HIV positive); 5. Patients with hyponatremia and/or hypokalemia, serum sodium = 50%, or the tumor thrombus of the main portal vein (occupying >= 50% of the vessel diameter), or the tumor thrombus invades the mesenteric vein/inferior vena cava; 8. There is currently clinically significant pleural effusion and ascites, defined as: pleural effusion and ascites requiring non-drug intervention (such as paracentesis) or increased drug intervention to maintain symptom control; 9. Patients who have received continuous systemic steroids (prednisone > 5mg/day or equivalent doses of other hormones) or other immunosuppressants within 14 days before apheresis, except for recent or current use of inhaled steroids; 10. Received systemic chemotherapy within 2 weeks or 5 half-lives before apheresis, or the toxicity of previous anti-tumor therapy has not recovered (> CTCAE version 5.0 grade 1), except for alopecia and pigmentation; 11. Before apheresis and lymphore pretreatment, received antibody therapy in the past, and within 4 weeks; 12. Previously received any inhibitory/stimulatory immune checkpoint molecular therapy (anti-PD-1/PD-L1 monoclonal antibody, OX40 agonist, 4-1BB agonist) prior to apheresis and lymphadenectomy , and within 3 half-lives; 13. Use of immunostimulatory or immunosuppressive therapy within 28 days before apheresis (such as interferon-alpha, interferon-beta, IL-2, etanercept, infliximab, tacrolimus, cyclosporine, or mycophenolic acid); 14. Use short-acting targeted therapy (such as tyrosine kinase inhibitors) within 72 hours before apheresis and infusion; 15. Radiation therapy within the last 28 days before apheresis, except for limited local palliative radiation therapy; 16. Past or present with other malignant tumors (except skin basal cell carcinoma, breast/cervical carcinoma in situ and other malignant tumors that have been effectively controlled without treatment within the past five years); 17. Patients with previous history or clinical evidence of primary or metastatic tumors of the species nervous system (CNS) including meningeal metastasis, unless previously treated for brain metastases, currently asymptomatic, and not requiring steroid or enzyme-inducing antiepileptic drug therapy in the last 14 days prior to screening; 18. Patients with any other existing central nervous system diseases (such as epilepsy, cerebrovascular ischemia/bleeding, dementia, etc.); 19. Uncontrolled hypertension
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 ContactHu Sheng
Outcome results
None listed