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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03815084
• Other study ID #: PD-1/DC-NK YNYY-01
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: February 1, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: January 2019
• Source: Allife Medical Science and Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• 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 .

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Allife Medical Science and Technology Co., Ltd.	Beijing Hospital, Henan Provincial Hospital, The First People's Hospital of Yunan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of treatment related adverse events	occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment.	1 year