gynecological cancer
Conditions
Interventions
1:CAR-T-meso adoptive cell therapy
2:NK-92 adoptive cell therapy
3:CAR-T adoptive cell therapy
4:CAR-T+CAR-NK adoptive cell therapy
5:CAR-T with the inhibitory receptor knockout adoptive cell therapy
6:CAR-T with the inhibitory receptor knockout+CAR-NK adoptive cell therapy
Sponsors
Nanjing Maternity and Child Health Care Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Metastatic or unresectable measurable gynecological cancers that express 2 of the 4 tumor associated antigen (mesothelin,EPCAM,L1CAM, Muc-16, one of the TAA positive cells must accounts for more than 50% of the tumor cells as assessed by immunohistochemistry); 2) Patients must have previously received at least one systemic standard care (or effective salvage chemotherapy regimens) for metastatic or unresectable disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred; 3) Greater than or equal to 18 years of age and less than or equal to 70 years of age; 4) Willing to sign a durable power of attorney; 5) Able to understand and sign the Informed Consent Document; 6) Clinical performance status of ECOG 0 or 1; 7) Life expectancy of greater than three months; 8) Serology: Seronegative for HIV antibody. Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus. 9) Hematology: Absolute neutrophil count greater than 1000/mm(3) without the support of filgrastim. WBC (> 3000/mm(3)). Platelet count greater than 100,000/mm(3). Hemoglobin greater than 8.0 g/dl. 10) Chemistry: Serum ALT/AST less or equal to 2.5 times the upper limit of normal. Serum creatinine less than or equal to 1.6 mg/dl. Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert s Syndrome who must have a total bilirubin less than 3.0 mg/dl.
Exclusion criteria
Exclusion criteria: 1. Neither of the antigen expressed on the tumor cells or all the TAA positive cells accounts for less than 50% of the tumor cells as assessed by immunohistochemistry; 2. Participated in any other trial in which receipt of an investigational study drug occurred within 28 days prior to enrollment and anticipated treatment with another investigational product while on study; 3. Active invasive cancer other than the one of the three cancers in this study; 4. Active autoimmune disease; 5. Patients with ongoing or active infection; 6. Prior therapy with gene modified cells; 7. Previous experimental therapy with chimeric antibodies; 8. History of allergy to murine proteins; 9. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40); 10. Any clinically significant pericardial effusion; CHF (NY Heart Association Grade II-IV) or cardiovascular condition that would preclude assessment of mesothelin induced pericarditis or that may worsen as a result of toxicities expected for this study. This determination will be made by a cardiologist; 11. Any clinically significant pleural or peritoneal effusion that cannot be drained with standard approaches. 12. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The tumor volume decreased or the tumor disapperaed; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival of patients;Overall survival of patient;Rate of response and rate of progression at the end of treatment;Quality of life; | — |
Countries
China
Contacts
Public ContactXuemei Jia
Nanjing Maternity and Child Health Care Hospital
Outcome results
None listed