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

NCT03815630 | Unknown Early Phase 1

• 1 other identifier: PD-1/DC CIK-YNYY-01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• occurrence of treatment related adverse events

  occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment.

  1 year

Study Arms (1)

PD-1 and dc-cik treatment group

EXPERIMENTAL

Drug: pd-1 and dc-cik cells

Interventions

pd-1 and dc-cik cells 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 .

PD-1 and dc-cik treatment group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

MeSH Terms

Interventions

alpha-Synuclein

Intervention Hierarchy (Ancestors)

Synucleins; Nerve Tissue Proteins; Proteins; Amino Acids, Peptides, and Proteins; Parkinson Disease Associated Proteins

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: January 24, 2019
• Study Start: February 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2021
• Last Updated: January 30, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share