Solid tumor
Conditions
Interventions
Experimental group:RT201
Sponsors
Jilin Provincial Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age=18 years old, regardless of sex; 2.The patient himself voluntarily signed the "informed consent form"; 3.Patients with advanced malignant tumor confirmed by histology or cytology have failed in standard treatment, or there is no standard treatment plan, or standard treatment is not applicable at this stage; 4.ECOG=2 5.Physical condition is good: KPS=70; 6.The estimated survival time is =3 months; 7.Have not received any treatment that may affect the evaluation of curative effect in the past 3 months; 8.The functions of liver, kidney and bone marrow are basically normal: HCT > 25%, white blood cell range 3.5-9.5×109/L, hemoglobin (Hb)=90g, lymphocyte+monocyte > 20%; Blood Cr=1.5×UNL (the upper limit of normal) and blood BIL = 1.5× UNL; ALT and AST=1.5×UNL (for patients with liver metastasis, ALT and ast = 5.0× UNL); 9.Women of childbearing age (15-49 years old) must have a pregnancy study within 7 days before starting treatment and the results are negative; Fertile patients must agree to use effective contraceptive measures to ensure that they are not pregnant during the study period and within 3 months after stopping treatment.
Exclusion criteria
Exclusion criteria: 1.Patients with central nervous system (CNS) metastasis or active CNS injury (i.e., imaging instability and symptomatic injury) (except patients with a single metastatic focus who are stable after treatment); 2.Within 4 weeks before the start of cell infusion, those who have received other anti-tumor treatments, taken corticosteroids (or analogues) or used systemic treatments that affect the immune system; 3.Blood pregnancy test positive or lactating female patients; 4.Patients who need anticoagulant therapy (warfarin or heparin); 5.The patient was allergic to naproxen, ibuprofen, trimetazidine/sulfamethoxazole and ampicillin. 6.Have a history of bone marrow transplantation or organ transplantation. 7.Patients who have previously used gene therapy drugs; 8.Patients with the following previous diseases or accompanying diseases:a) Patients who have been diagnosed as serious autoimmune diseases need systemic immunosuppressants (steroids) for a long time (more than 2 months) or immune-mediated symptomatic diseases, including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE) and autoimmune vasculitis (for example, Wegener's granulomatosis;b) Patients previously diagnosed with motor neuron disease caused by autoimmune disease; c) Patients with toxic epidermal necrolysis (TEN) in the past; d) Patients suffering from any mental illness, including dementia and mental state changes, which may affect informed consent and the understanding and performance of relevant questionnaires;e) It is determined that patients with serious uncontrollable diseases may be affected by this study; f) Patients with active malignant tumors such as basal or squamous skin cancer, superficial bladder cancer and breast cancer in situ in the past 5 years who have been completely cured and do not need follow-up treatment are not included; 9.Patients who have used immunotherapy for cancer in the past 6 months include: CIK, DC, DC-CIK, LAK and other lymphocyte-based immunotherapy patients; 10.Active/chronic human immunodeficiency virus (HIV), syphilis serological positive, active hepatitis B (hepatitis B surface antigen (HBsAg) positive and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) > 500IU/ml or the lower detection limit of the research center [only when the lower detection limit of the research center is higher than 500 iu/ml]), or hepatitis C virus antibody positive; 11.Have a clear history of drug allergy or an allergic constitution; 12.Patients participating in other clinical trials at the same time 13.Other circumstances in which the researcher thinks that the patient should not participate in this experimental study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival(PFS);Overall survival (OS);Disease control rate (DCR);Remission duration (DOR); | — |
Countries
China
Contacts
Public ContactCheng Ying
Jilin Provincial Tumor Hospital
Outcome results
None listed