A Study of PD1 Combined With Dc-cik in the Treatment of Solid Tumors

NCT ID: NCT03815630

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

This is a single center、single arm、open-label, to investigate the safety and efficacy of PD-1 and DC-CIK with anti-solid tumor

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-cik treatment group

Group Type: EXPERIMENTAL

pd-1 and dc-cik cells

Intervention Type: DRUG

Total dose of 10ml Keytruda will be administered at day0, 60million DC cells and 1.5 billion CIK at day1, 1.5 billion CIK cells at day2, 1.5 billion CIK cells at day3 .

Interventions

pd-1 and dc-cik cells

Total dose of 10ml Keytruda will be administered at day0, 60million DC cells and 1.5 billion CIK at day1, 1.5 billion CIK cells at day2, 1.5 billion CIK 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;

7. 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 Yunnan 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 CIK-YNYY-01

Identifier Type: -

Identifier Source: org_study_id