A Study of PD1 Combined With Dc-cik in the Treatment of Solid Tumors (DC-CIK)

Clinical Study on the Safety and Efficacy of Pd-1 Combined With Dc-cik in the Treatment of Solid Tumors

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

Study Overview

• Status: Unknown
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: pd-1 and dc-cik cells

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PD-1 and dc-cik treatment group	Drug: 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 .

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Allife Medical Science and Technology Co., Ltd.
• Collaborators: Beijing Hospital; The First People's Hospital of Yunnan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital; Henan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: PD-1/DC CIK-YNYY-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No