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

• Sponsor: Allife Medical Science and Technology Co., Ltd. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03815630
• Collaborator: The First People's Hospital of Yunnan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital (Other), Henan Provincial People's Hospital (Other), Beijing Hospital (Other)
• Enrollment: 100
• Arm: 1
• Anticipated Duration (Months): 24

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Drug: pd-1 and dc-cik cells	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Clinical Study on the Safety and Efficacy of Pd-1 Combined With Dc-cik in the Treatment of Solid Tumors
• Anticipated Study Start Date: Feb 1, 2019
• Anticipated Primary Completion Date: Feb 1, 2020
• Anticipated Study Completion Date: Feb 1, 2021

Arms and Interventions

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 .

Outcome Measures

Primary Outcome Measures

1. occurrence of treatment related adverse events [1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Serological examination:

• Absolute neutrophil count (ANC) <0.75x109/L

• Platelet count (PLT) <50x109/L

1. Active hepatitis B (HBV-DNA > 1000 copies / ml), hepatitis C, or uncontrolled infection;

2. 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;

3. Active CNS disease (tumor cells in CSF);

4. Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;

5. 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;

6. The New York Heart Association (NYHA) is classified as Level III or higher;

7. Uncontrolled diabetes;

8. With other uncontrolled diseases, the investigator believes that it is not suitable for joining;

9. Any situation that the investigator believes may increase the risk of the subject or interfere with the test results.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allife Medical Science and Technology Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03815630
• Other Study ID Numbers: PD-1/DC CIK-YNYY-01
• First Posted: Jan 24, 2019
• Last Update Posted: Jan 30, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Jan 30, 2019