High-risk Soft Tissue Sarcoma
Conditions
Brief 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.
Interventions
BIOLOGICALAdenovirus-transfected DC + CIK
Adenovirus-transfected autologous DC vaccine plus CIK cells
Sponsors
Affiliated Hospital to Academy of Military Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS/OS | 1 years after DC/CIK treatment |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | 3 days within DC/CIK treatment |
Countries
China
Contacts
Primary ContactBin Zhang, M.D., Ph.D.
Outcome results
None listed