A Study of PD1 Combined With DC-NK Cell in the Treatment of Solid Tumors

Allife Medical Science and Technology

Status and phase: Unknown; Early Phase 1

Conditions: Solid Tumor

Treatments: Drug: pd-1 and DC-NK cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03815084

PD-1/DC-NK YNYY-01

Details and patient eligibility

About

clinical study on the safety and efficacy of PD1 combined with dc-Nk in the treatment of solid tumors

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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; 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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

PD-1 and DC-NK treatment group

Experimental group

Treatment:

Drug: pd-1 and DC-NK cells