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

June 28, 2024 updated by: Affiliated Hospital to Academy of Military Medical Sciences

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bin Zhang, M.D., Ph.D.
  • Phone Number: +86-010-6694-7125
  • Email: zb307ctc@163.com

Study Locations

  • China
      • Beijing, China, 100071
        • Recruiting
        • Department of Hematopoietic Stem Cell Transplantation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adenovirus-transfected DC + CIK
Adenovirus-transfected autologous DCs + CIK cells
Biological: Adenovirus-transfected DC + CIK
Adenovirus-transfected autologous DC vaccine plus CIK cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PFS/OS
Time Frame: 1 years after DC/CIK treatment
1 years after DC/CIK treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: 3 days within DC/CIK treatment
3 days within DC/CIK treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Investigators

  • Principal Investigator: Chen Hu, M.D., Ph.D., Affiliated Hospital to Academy of Military Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

July 9, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimated)

July 12, 2013

Study Record Updates

Last Update Posted (Actual)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 307-CTC-DC/CIK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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