DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With AML

NCT ID: NCT01898663

Last Updated: 2024-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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High-risk Soft Tissue Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adenovirus-transfected DC + CIK

Adenovirus-transfected autologous DCs + CIK cells

Group Type EXPERIMENTAL

Adenovirus-transfected DC + CIK

Intervention Type BIOLOGICAL

Adenovirus-transfected autologous DC vaccine plus CIK cells

Interventions

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Adenovirus-transfected DC + CIK

Adenovirus-transfected autologous DC vaccine plus CIK cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chen Hu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital to Academy of Military Medical Sciences

Locations

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Department of Hematopoietic Stem Cell Transplantation

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bin Zhang, M.D., Ph.D.

Role: CONTACT

+86-010-6694-7125

Facility Contacts

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Dan ho Wang, M.M.

Role: primary

+86-010-6694-7102

Other Identifiers

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307-CTC-DC/CIK

Identifier Type: -

Identifier Source: org_study_id

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