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

NCT ID: NCT03815084

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2021-02-01

Brief Summary

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

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

PD-1 and DC-NK treatment group

Group Type: EXPERIMENTAL

pd-1 and DC-NK cells

Intervention Type: DRUG

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 .

Interventions

pd-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 .

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First People's Hospital of Yunan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital

UNKNOWN

Sponsor Role: collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role: collaborator

Allife Medical Science and Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PD-1/DC-NK YNYY-01

Identifier Type: -

Identifier Source: org_study_id