CClinicalTrials.gg
Status unknownNCT03815084Updated Jan 30, 2019

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

An Early Phase 1 interventional study of pd-1 and DC-NK cells in Solid Tumor, sponsored by Allife Medical Science and Technology Co., Ltd.. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-01-30.

Sponsored by Allife Medical Science and Technology Co., Ltd. · Early Phase 1, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
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Study summary

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

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Conditions studied

  • Solid Tumor

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Allife Medical Science and Technology Co., Ltd. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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; There are measurable target lesions.

Exclusion criteria

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    PD-1 and DC-NK treatment group

    Drug: pd-1 and DC-NK cells

Interventions

  • Drugpd-1 and DC-NK cells

    total dose of 10ml KEYTRUDA® (pembrolizumab) will be administered at day0, 60million DC cells and 3 billion NK at day1, 3 billion NK cells at day2, 3 billion NK cells at day3 .

06

What researchers measure

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.

    Time frame: 1 year

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03815084
Lead sponsor
Allife Medical Science and Technology Co., Ltd.
Collaborators
The First People's Hospital of Yunan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital, Henan Provincial People's Hospital, Beijing Hospital
Responsible party
Sponsor
First posted
Jan 24, 2019
Start date
Feb 1, 2019 (estimated)
Primary completion
Feb 1, 2020 (estimated)
Completion
Feb 1, 2021 (estimated)
Last update
Jan 30, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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