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

Early Phase 1

• Conditions: Solid Tumor
• Interventions: Drug: pd-1 and dc-cik cells

• Registration Number: NCT03815630
• Lead Sponsor: Allife Medical Science and Technology Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-01-23
• Study First Posted: 2019-01-24
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-30
• Study Start: 2019-02-01
• Primary Completion: 2020-02-01
• Study Completion: 2021-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD-1 and dc-cik treatment group	pd-1 and dc-cik cells	-

Primary Outcome Measures

Name	Time	Method
occurrence of treatment related adverse events	1 year	occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment.