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

Affiliated Hospital to Academy of Military Medical Sciences

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

High-risk Soft Tissue Sarcoma

Treatments

Biological: Adenovirus-transfected DC + CIK

Study type

Interventional

Funder types

Other

Identifiers

NCT01898663

307-CTC-DC/CIK

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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