Solid TumorEarly Phase 1NCT03815084

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

A Early Phase 1 study testing pd-1 and DC-NK cells in people with Solid Tumor, run by Allife Medical Science and Technology Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Solid Tumor
What is being tested?: pd-1 and DC-NK cells
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: No sites listed yet
Study dates: 1 Feb 2019to 1 Feb 2021
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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

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

About this study

Official title: Clinical Study on the Safety and Efficacy of PD1 Combined With DC-NK Cell in the Treatment of Solid Tumors

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

Conditions: Solid Tumor
Being tested: pd-1 and DC-NK cells

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pd-1 and DC-NK cellsDrug
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 .

Study groups in NCT03815084
Study group	Role	What they receive
PD-1 and DC-NK treatment group	Experimental	Not described Receives: Drug: pd-1 and DC-NK cells

What is being measured

The primary outcome is the main question the study is designed to answer.

occurrence of treatment related adverse events
occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20191 Feb 2021

First posted24 Jan 2019
Study start1 Feb 2019 (estimated)
Primary completion1 Feb 2020 (estimated)
Study completion1 Feb 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

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

IDs, dates and publications

ClinicalTrials.gov ID: NCT03815084
Sponsor's protocol ID: PD-1/DC-NK YNYY-01
Status last verified: Jan 2019
First submitted: 21 Jan 2019
Last updated: 30 Jan 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study on the Safety and Efficacy of PD1 Combined With DC-NK Cell in the Treatment of Solid Tumors
ClinicalTrials.gov ID: NCT03815084
Acronym / sponsor ID: PD-1/DC-NK YNYY-01
Conditions: Solid Tumor
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Allife Medical Science and Technology Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: The First People's Hospital of Yunnan, Henan Provincial People's Hospital, Beijing Hospital
Study start: 1 Feb 2019 (estimated)
Primary completion: 1 Feb 2020 (estimated)
Study completion: 1 Feb 2021 (estimated)
First posted: 24 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PD-1 and DC-NK treatment group	Experimental	Drug: pd-1 and DC-NK cells

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (16 listed)

Liver and kidney function:
Serological examination:
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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
pd-1 and DC-NK cellstotal 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 .	Drug	PD-1 and DC-NK treatment group

Primary outcome

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
Individual participant dataSharing planned: No

Related trials for Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing pd-1 and DC-NK cells in people with Solid Tumor, run by Allife Medical Science and Technology Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

occurrence of treatment related adverse events (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03815084.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.