High-risk Soft Tissue SarcomaPhase 1/2NCT01898663
DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With AML
A Phase 1/2 study testing Adenovirus-transfected DC + CIK in people with High-risk Soft Tissue Sarcoma, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
The aim of this Phase Ⅰ/Ⅱ study is to evaluate the safety and efficacy of dendritic cells (DCs) vaccine combined with cytokine-induced killer (CIK) cells in patients with AML. Experimental recombinant adenovirus-transfected DCs, which engineered to express MUC1 and Survivin are used for DCs-based immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-risk Soft Tissue Sarcoma
- What is being tested?
- Adenovirus-transfected DC + CIK
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to 30 Dec 2024
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consistent with the diagnosis of AML
- Age≥18 years at time of consent
- KPS(Karnofsky Performance Scale) ≥70
- Patient's written informed consent
- No steroid therapy within 4 weeks of first DC vaccination
- Stable disease, complete response and partial response(WHO, RECIST)
- Predicted survival≥3 months
Who cannot join
- Serious dysfunction of vital organs(heart, liver or kidney)
- Received organ transplantation
- Patients with other malignancies or brain metastases
- History of autoimmune diseases
- Pregnant and breast-feeding patient
- Active or chronic infectious diseases
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- History of allergy or hypersensitivity to study product excipients
- Currently participating in another clinical trial
- Received chemotherapy, radiotherapy, immune inhibitor (such as corticosteroid) or other immunotherapy (such as vaccine) during prior 4 weeks
- Unfit for participating in this clinical trial in investigators' opinions
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hematopoietic Stem Cell Transplantation
Beijing, 100071
Dan ho Wang, M.M., +86-010-6694-7102, wangdh307@sina.com
About this study
Official title: Safety and Therapeutic Efficacy of DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With AML: a Phase Ⅰ/Ⅱ Study
The aim of this Phase Ⅰ/Ⅱ study is to evaluate the safety and efficacy of dendritic cells (DCs) vaccine combined with cytokine-induced killer (CIK) cells in patients with AML. Experimental recombinant adenovirus-transfected DCs, which engineered to express MUC1 and Survivin are used for DCs-based immunotherapy. Based on the results of our previously performed preclinical study with DCs vaccine combined with CIK cells, the investigators plan to perform the clinical trial.
- Conditions
- High-risk Soft Tissue Sarcoma
- Being tested
- Adenovirus-transfected DC + CIK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenovirus-transfected DC + CIKBiological
Adenovirus-transfected autologous DC vaccine plus CIK cells
| Study group | Role | What they receive |
|---|---|---|
| Adenovirus-transfected DC + CIK | Experimental | Adenovirus-transfected autologous DCs + CIK cells Receives: Biological: Adenovirus-transfected DC + CIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS/OS
Measured: 1 years after DC/CIK treatment
Secondary outcomes (1)
Number of participants with adverse events
Measured: 3 days within DC/CIK treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJun 2013
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk Soft Tissue SarcomaStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Hu, M.D., Ph.D., Principal investigator, Affiliated Hospital to Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898663
- Sponsor's protocol ID
- 307-CTC-DC/CIK
- Status last verified
- Jun 2024
- First submitted
- 9 Jul 2013
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Therapeutic Efficacy of DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With AML: a Phase Ⅰ/Ⅱ Study
- ClinicalTrials.gov ID
- NCT01898663
- Acronym / sponsor ID
- 307-CTC-DC/CIK
- Conditions
- High-risk Soft Tissue Sarcoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 12 Jul 2013 (estimated)
- 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.
The aim of this Phase Ⅰ/Ⅱ study is to evaluate the safety and efficacy of dendritic cells (DCs) vaccine combined with cytokine-induced killer (CIK) cells in patients with AML. Experimental recombinant adenovirus-transfected DCs, which engineered to express MUC1 and Survivin are used for DCs-based immunotherapy. Based on the results of our previously performed preclinical study with DCs vaccine combined with CIK cells, the investigators plan to perform the clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adenovirus-transfected DC + CIK | Experimental | Biological: Adenovirus-transfected DC + CIKAdenovirus-transfected autologous DCs + CIK cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Consistent with the diagnosis of AML
- Age≥18 years at time of consent
- KPS(Karnofsky Performance Scale) ≥70
- Patient's written informed consent
- No steroid therapy within 4 weeks of first DC vaccination
Key exclusion criteria (10 listed)
- Serious dysfunction of vital organs(heart, liver or kidney)
- Received organ transplantation
- Patients with other malignancies or brain metastases
- History of autoimmune diseases
- Pregnant and breast-feeding patient
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 |
|---|---|---|
| Adenovirus-transfected DC + CIKAdenovirus-transfected autologous DC vaccine plus CIK cells | Biological | Adenovirus-transfected DC + CIK |
Primary outcome
PFS/OS
Time frame: 1 years after DC/CIK treatment
1 secondary outcome
Number of participants with adverse events
Time frame: 3 days within DC/CIK treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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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.
Chen Hu, M.D., Ph.D. principal investigator
Affiliated Hospital to Academy of Military Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Adenovirus-transfected DC + CIK in people with High-risk Soft Tissue Sarcoma, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
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 7 inclusion and 10 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 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Bin Zhang, M.D., Ph.D. (+86-010-6694-7125, zb307ctc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS/OS (time frame: 1 years after DC/CIK treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2024.