Clinical trial NCT04388033: Clinical Study of an Dendritic and Glioma Cells Fusion Vaccine With IL-12 for Treatment-naïve GBM Patients.
Official title: Clinical Study of an Dendritic and Glioma Cells Fusion Vaccine With IL-12 for Treatment-naïve GBM Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Glioblastoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms
Neoplasms, Nerve Tissue
Vaccines
Immunologic Factors
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Hangzhou Medical Biotechnology Co., Ltd
name: CyTIX.Inc
First posted: 2020-05-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A multi-center, open-label, single-arm, phase I/II clinical study is designed to test the safety and immunogenicity of an investigational Dendritic and Glioma Cells Fusion vaccine given with IL-12 for treatment-naïve patients after resection of glioblastoma.

Detailed description: This clinical trail includes two phases: basic treatment phase and immunotherapy phase. In basic treatment phase, patients will receive concomitant radiation and TMZ-chemotherapy. In immunotherapy phase, besides maintenance chemotherapy with TMZ, Fusion cells will be administered with IL-12 to enhance the immunity of patients.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years; Male or Female.
2. Treatment-naïve patients after Resection of Glioblastoma.
3. Histologically confirmed Glioblastoma.
4. KPS ≥ 60
5. White blood cell count (WBC) ≥ 3.0 x 109/L; peripheral blood lymphocyte (PBL) ≥ 25%.
6. Echocardiographic assessment of left ventricular ejection fraction (LVEF) ≥ 40% within 1 month of enrollment.
7. Patients must be able to understand the investigational nature of the study and provide informed consent.

Exclusion Criteria:

1. Those who are allergic constitution, or allergic to biological products, or have contraindications to CT and MRI1 contrast agents.
2. Those with severe autoimmune diseases or immunodeficiency diseases.
3. Those who are expected to take systemic corticosteroids within three months.
4. Those who needs long-term usage of immunosuppressive agents.
5. Those with infectious diseases, including syphilis, AIDS, hepatitis B, hepatitis C, etc.
6. Those who plan to receive any other anti-tumor treatment during the trial.
7. Combined with serious primary diseases of cardiovascular, liver and kidney, and liver function (ALT, AST, Y-GT) exceeding 1.5 times of the upper limit: BUN or Cr exceeding 1.5 times of the upper limit of normal value.
8. Patients with other malignant tumors.
9. Those with active infections, etc.
10. Suspected or confirmed a history of alcohol and drug abuse.
11. Psychiatric illness, intellectual and language disabilities that compromise the informed consent process, at the discretion of the investigator.
12. Women who are pregnant or nursing.
13. Women of childbearing age who refuse to contraception.
14. Active participation in another clinical treatment trials.
15. According to the judgment of the investigator, other conditions that the plan cannot be followed.

Primary outcomes:
measure: Adverse Events (AE) / Serious Adverse Events (SAE)
timeFrame: 2-3 years
measure: Progression free survival (PFS) at 6 months
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Secondary outcomes:
measure: Immunological Assays
timeFrame: 2-3 years
measure: Overall survival (OS) time
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Hong Shen, MD
role: STUDY_CHAIR
References: