Advanced recurrent or refractory malignant solid tumors
Conditions
Interventions
Case series:anti PD-1 expression meso CAR-T cells
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with relapsed or refractory advanced solid malignancies (diagnosed by histology or cytology detection); 2. Progressive disease and no response after at least second-line therapy; 3. Aged 18 years to 80 years; 4. Life expectancy>=3 months; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 6. Adequate venous access for peripheral blood mononuclear cell (PBMC) apheresis, and no other contraindications; 7. Immunohistochemistry (IHC) score of MESO on tumor tissue >=1+; 8. Adequate hepatic function, renal function and bone marrow function (withhin 7 days before enrollment): white blood cell (WBC)>=3.0x10^9/L; platelet>=100x10^9/L; hemoglobin>=90 g/L; lymphocyte >=0.7x10^9/L; total bilirubin <=2 ULN; alanine aminotransferase and aspartate transaminase (ALT and AST) <=2.5 ULN; serum creatinine <=1.5 ULN. 9. No other treatments (chemotherapy, radiotherapy, etc.) within four weeks before enrollment; 10. at least one measurable tumor lesion; 11. Patients have adequate ability to understand, sign informed consents and take part in the clinical research voluntarily; 12. Female patients in child bearing period must have evidence of negative pregnancy test, and agree to take effective contraceptive measures until 4 months after cells infusion.
Exclusion criteria
Exclusion criteria: 1. Patients with two or more kinds of tumors; 2. Patients with active viral or bacterial infection, and have failed to be controlled by anti-infective treatment; 3. Patients with seropositive reponse of Human immunodeficiency virus (HIV) and syphilis, or fail to control the hepatitis B virus or hepatitis C virus infection; 4. Patients with active rheumatic diseases, organ transplantation and other diseases affecting the immune system seriously; 5. Patients with severe heart and lung dysfunction; 6. Patients with severe chronic diseases of kidney, liver and other important organs; 7. Patients with any other serious illnesses that the investigators consider it will may affect the patient's treatments, follow-up or assessment, including any uncontrolled clinically significant neurological or psychiatric disorders, immunoregulatory diseases, metabolic diseases, infectious diseases and so on; 8. Patients who take part in clinical trials of other drugs or biological therapy at present or within 30 days before enrollment; 9. Patients who need long-term use of immunosuppressive drugs or patients who are undergoing treatment of autoimmune diseases; 10. Patients who need long-term use of glucocorticoid; 11. Women patients in gestation period or suckling period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of infusion of autologous PD-1 antibodies expressing MESO-targeted CAR-T cells;The efficacy of the treatment using PD-1 antibodies expressing MESO-CAR-T cells for advanced solid tumors; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival;Change of life quality;Proliferation and persistence of MESO specific CAR-T cells in peripheral blood of the patients after treatment;PD-1 antibodies level in peripheral blood of the patients after treatment; | — |
Countries
China
Contacts
Public ContactQing Xu
Shanghai Tenth People's Hospital
Outcome results
None listed