Abdominal metastatic malignant tumor
Conditions
Interventions
Group 1 (1): Dose level 1 for patients with CAR-T cell therapy incremental dose:Intraperitoneal reinfusion of TX103 chimeric antigen receptor T cells 1.1×10^8 cells/kg
Group 1 (2): Dose level 1 for patients with CAR-T cell therapy decremental dose:Intraperitoneal reinfusion of TX103 chimeric antigen receptor T cells 9.0×10^7 cells/kg
Group 2 (1): Dose level 2 for patients with CAR-T cell therapy incremental dose:Intraperitoneal reinfusion of TX103 chimeric antigen receptor T cells 4.5×10^8 cells/kg
Group 2 (2): Dose level 2 for patients with CAR-T cell therapy decremental dose:Intraperitoneal reinfusion of TX103 chimeric antigen receptor T cells 3.0×10^8 cells/kg
Group 3(1): Dose level 3 for patients with CAR-T cell therapy incremental dose:Intraperitoneal reinfusion of TX103 chimeric antigen receptor T cells 1.0×10^9 cells/kg
Group 3(2): Dose level 3 for patients with CAR-T cell therapy decremental dose:Intraperitoneal reinfusion of TX103 chimeric antigen receptor T cells 8.0×10^8 cells/kg
Group 4(1): Dose level 4 for patients with CAR-T cell therapy incremental dose:Intraperitoneal reinfusion of TX103 chimeric antigen receptor T cells 2.0×10^9 cells/kg
Group 4(2): Dose level 4 for patients with CAR-T cell therapy incremental dose:Intraperitoneal reinfusion of TX103 chimeric antigen receptor T cells 1.5×10^9 cells/kg
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. male or female aged >=18 years old; 2. Women of childbearing age must be negative in serum or urine pregnancy test within 24 hours before administration; 3. subjects must agree to follow contraceptive instructions during treatment; 4. Women must be in a non-lactation state; 5. the subjects must be patients with abdominal metastasis of solid tumor who were positive for TX103 expression, failed standard treatment or could not tolerate standard treatment or refused standard treatment, including those with abdominal metastasis accompanied by distant metastasis of other organs and tissues. Documents proving abdominal metastasis may include laparoscopy or imaging reports, and the results of the examination 2 months before admission can be accepted; 6. subjects must have at least one lesion that can be measured or evaluated by CT or MRI according to RECIST 1.1, or at least one lesion that can be evaluated according to PCI score by laparoscopic exploration; 7. the ECOG physical status score 0-2; 8. 10-15 slices of tumor tissue or unstained tumor tissue sections for biomarker analysis and related pathological reports must be provided for biomarker evaluation; 9. the estimated survival time of the patient is at least 3 months; 10. Laboratory screening must meet the following criteria (see NCI CTCAE version 5); (1) WBC .=3000/ul; (2) neutrophils .=1500/ul; (3) platelets >=100x10^3/ul; (4) hemoglobin >=9.0g/dl; (5) Serum albumin >=3.0g/dl; (6) Serum creatinine <=1.5 ULN; (7) AST <=3.0 ULN (or <=5.0 ULN, if there is liver metastasis); (8) ALT <=3.0 ULN (or <=5.0 ULN, if there is liver metastasis); (9) Total bilirubin <=1.5 ULN (or <=2.5 ULN, if there is liver metastasis); 11) within one month, the left ventricular ejection fraction ((LVEF)) was more than 50% by color Doppler echocardiography; 12. the subject must sign a written informed consent form and indicate the date; 13. for the patients with abdominal metastasis of solid tumor whose TX103 status is unknown, the TX103 test should be performed in advance to participate in the clinical study, and the informed consent form of pre-screening should be signed. Except for those who have signed the informed consent form; 14. subjects must be voluntary and able to comply with scheduled treatment plans, laboratory tests, follow-up and other research requirements.
Exclusion criteria
Exclusion criteria: 1) except for patients with simple celiac lymph node metastasis; 2) subjects who could not control ascites through appropriate intervention; 3) subjects with known or suspected autoimmune diseases and immunodeficiency diseases; 4) subjects who need to use corticosteroids or other immunosuppressive drugs for systemic treatment during the treatment period; 5) subjects who have received other gene therapy in the past; 6) subjects with a history of organ transplant; 7) subjects with severe mental disorders; 8) participated in other clinical studies in the past month; 9) subjects who were clinically assessed to be unable to tolerate or unsuitable for laparoscopic exploration; 10) the researchers believe that it may increase the risk associated with participating in the study, the study of drug administration, or any serious or uncontrolled disease or active infection that affects the subject's ability to accept the drug in the study; 11) the subjects were tested for active hepatitis B and / or hepatitis C. (hepatitis B: HBV DNA > 500IU/ml or copy number > 2500 copies / ml; Hepatitis C: HCV antibody is positive and HCV- RNA level is higher than the lower limit of detection); 12) the subjects tested positive for HIV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity;Objective response rate;Progression-free?survival;Overall survival;Duration of response;Adverse event;Recommended phase 2 dose; | — |
Countries
China
Contacts
Public ContactPan Chi, Xiaoyan Lin, Gangxiong Huang
Fujian Medical University Union Hospital
Outcome results
None listed