malignant solid tumors
Conditions
Interventions
Experimental group:TIL therapy
Sponsors
Zhejiang Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years, male or female; 2. The expected survival time is greater than 3 months; 3. ECOG score 0-1 points; 4. Patients with locally advanced unresectable or advanced solid tumors, who have received at least 1 line of standard therapy in the past with poor response, or relapsed after remission, and there is no standard therapy plan; or those who cannot or refuse to receive standard therapy for various reasons; 5. There is a measurable lesion at baseline. If the subject has only one measurable lesion at baseline, the lesion area must have not received radiotherapy before, or there is evidence that the lesion has progressed significantly after the end of radiotherapy; 6. Bone marrow function and coagulation function meet the following criteria (subjects are not allowed to receive blood transfusion or growth factors due to neutrophil count, platelet or hemoglobin lower than study requirements within 7 days before laboratory test): (1) Hemoglobin>= 9.0 g/dL; (2) Absolute neutrophil count >=1.5 x 10^9/L; (3) Platelet count >= 100 x 10^9/L (platelet count >= 75 x 10^9/L in patients with liver cancer); (4) INR or PT = 50 mL/min. 9. Cardiac left ventricular ejection fraction > 50%; 10. The venous access required for collection can be established, and the collection of peripheral blood mononuclear cells (PBMC) can be carried out according to the judgment of the investigator; 11. The subjects can understand the informed consent form, participate voluntarily and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects with hepatitis B surface antigen (HBsAg) or core antibody (HBcAg) positive and peripheral blood HBV DNA titer >= 102 iu/ml; hepatitis C anti (HCV) body positive and peripheral blood HCV RNA positive; human immunodeficiency HIV (HIV) antibody positive; syphilis test positive; 2. Subjects with untreated symptomatic brain metastases; if the subject's brain metastases have been treated, and the metastases are stable (brain imaging studies show stable lesions at least 4 weeks before the first dose, and there are no new lesions); Patients with neurological symptoms, or neurological symptoms have returned to baseline levels), and no evidence of new or enlarged brain metastases, are allowed to enroll; 3. Participated in any other interventional clinical trials within 28 days before administration of this trial; 4. Received other anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter but at least 2 weeks) before administration of this trial; 5. Received radical radiotherapy within 3 months before administration of this trial; palliative radiotherapy is allowed 2 weeks before administration, and the dose of radiotherapy meets the local diagnosis and treatment standards for palliative care, and the coverage of radiotherapy is less than 30% of the bone marrow area; 6. The toxicity of previous anti-tumor therapy has not recovered to CTCAE <= grade 1 (NCI-CTCAE v5.0) or baseline level, except for alopecia (any grade allowed) and peripheral neuropathy (required to recover to <= grade 2); 7. Past history of allogeneic bone marrow or organ transplantation; 8. Pregnant and/or lactating women; 9. Conditions that other investigators believe will affect the safety or compliance of the treatment in this study, including but not limited to psychiatric diseases, uncontrolled massive serous effusion, or those requiring repeated drainage (recurrence within 2 weeks after intervention). Moderate to large amount of serous effusion such as pleural effusion, pericardial effusion, ascites, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;progression-free survival; | — |
Countries
China
Contacts
Public ContactWu Guoqing
Zhejiang Provincial People's Hospital
Outcome results
None listed