Solid Tumor
Conditions
Brief summary
clinical study on the safety and efficacy of PD1 combined with dc-Nk in the treatment of solid tumors
Interventions
DRUGpd-1 and DC-NK cells
total dose of 10ml KEYTRUDA® (pembrolizumab) will be administered at day0, 60million DC cells and 3 billion NK at day1, 3 billion NK cells at day2, 3 billion NK cells at day3 .
Sponsors
The First People's Hospital of Yunan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital
Henan Provincial People's Hospital
Beijing Hospital
Allife Medical Science and Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Previously receiving ≥ first-line regimen chemotherapy; 2. Age over 3 years old and less than 14 years old; 3. The expected survival period is more than 3 months; 4. ECOG≤2; 5. Vital organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥ 50%, no obvious abnormality in ECG; blood oxygen saturation ≥ 90%; creatinine clearance calculated by Cockcroft-Gault formula ≥ 40ml/min; ALT and AST ≤ 3 times the normal range, total bilirubin ≤ 2.0 mg / dl; 6. Blood routine: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×109/L; There are measurable target lesions.
Exclusion criteria
1. Liver and kidney function: * Total bilirubin \> 2 x ULN (Gilbert syndrome \> 3 x ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 3 × ULN * Serum creatinine clearance \>60mL/min 2. Serological examination: * Absolute neutrophil count (ANC) \<0.75x109/L * Platelet count (PLT) \<50x109/L 3. Active hepatitis B (HBV-DNA \> 1000 copies / ml), hepatitis C, or uncontrolled infection; 4. The number of days of chemotherapy medication and the administration of hormones below 5mg is ≤3, and the number of days of withdrawal of hormones greater than 5mg is ≤5; 5. Active CNS disease (tumor cells in CSF); 6. Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation; 7. creatinine \> 1.5 times the upper limit of normal or ALT / AST \> 3 times the upper limit of normal or bilirubin \> 2 times the upper limit of normal; 8. The New York Heart Association (NYHA) is classified as Level III or higher; 9. Uncontrolled diabetes; 10. With other uncontrolled diseases, the investigator believes that it is not suitable for joining; 11. Any situation that the investigator believes may increase the risk of the subject or interfere with the test results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| occurrence of treatment related adverse events | 1 year | occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment. |
Outcome results
None listed