A Study of PD1 Combined With DC-NK Cell in the Treatment of Solid Tumors

Study Overview
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Brief Summary
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clinical study on the safety and efficacy of PD1 combined with dc-Nk in the treatment of solid tumors

Official Title
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Clinical Study on the Safety and Efficacy of PD1 Combined With DC-NK Cell in the Treatment of Solid Tumors

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: pd-1 and DC-NK cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously receiving ≥ first-line regimen chemotherapy; Age over 3 years old and less than 14 years old; The expected survival period is more than 3 months; ECOG≤2; 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; Blood routine: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×109/L; There are measurable target lesions. Exclusion Criteria: 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 Serological examination: Absolute neutrophil count (ANC) <0.75x109/L Platelet count (PLT) <50x109/L Active hepatitis B (HBV-DNA > 1000 copies / ml), hepatitis C, or uncontrolled infection; 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; Active CNS disease (tumor cells in CSF); Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation; 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; The New York Heart Association (NYHA) is classified as Level III or higher; Uncontrolled diabetes; With other uncontrolled diseases, the investigator believes that it is not suitable for joining; Any situation that the investigator believes may increase the risk of the subject or interfere with the test results.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD-1 and DC-NK treatment group<br> | Drug: pd-1 and DC-NK cells<br>* 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 .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of treatment related adverse events | occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment. | 1 year |