Safety and Therapeutic Efficacy of DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With AML: a Phase Ⅰ/Ⅱ Study

Who is this study for? Patients with High-risk Soft Tissue Sarcoma
What treatments are being studied? Adenovirus-Transfected Dendritic Cells+Cytokine-Induced Killer
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Department of Hematopoietic Stem Cell Transplantation
RECRUITING
Beijing
Contact Information
Primary
Bin Zhang, M.D., Ph.D.
zb307ctc@163.com
+86-010-6694-7125
Time Frame
Start Date: 2013-06
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 30
Treatments
Experimental: Adenovirus-transfected DC + CIK
Adenovirus-transfected autologous DCs + CIK cells
Related Therapeutic Areas
Sponsors
Leads: Affiliated Hospital to Academy of Military Medical Sciences

This content was sourced from clinicaltrials.gov