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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAffiliated Hospital to Academy of Military Medical Sciences

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Consistent with the diagnosis of AML

Age≥18 years at time of consent

KPS(Karnofsky Performance Scale) ≥70

Patient's written informed consent

Disqualifiers

Serious dysfunction of vital organs(heart, liver or kidney)

Received organ transplantation

Patients with other malignancies or brain metastases

History of autoimmune diseases

Trial design

Design model

Single group

Treatments tested in this trial

  • Adenovirus-transfected DC + CIK

    Biological/Vaccine

    Adenovirus-transfected autologous DC vaccine plus CIK cells

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Adenovirus-transfected DC + CIKExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PFS/OS

Time frame
1 years after DC/CIK treatment

Secondary outcomes

1

Number of participants with adverse events

Time frame
3 days within DC/CIK treatment

Other outcomes

Sponsors and contacts

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