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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04277221
Other study ID # ADCTA-SSI-G1
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 19, 2019
Est. completion date December 31, 2022

Study information

Verified date March 2020
Source Safe Save Medical Cell Sciences & Technology Co.,Ltd.
Contact Wen-Kuang Yang, PhD
Phone +886-3-5506696
Email wkyang@safesavecell.com.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To confirm the result of previous Phase I/II and phase II clinical trials, this trial is to test the efficacy and safety of ADCTA immunotherapy plus the standard therapy in comparison with standard therapy alone in patients with recurrent GBM.


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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Autologous Dendritic Cell/Tumor Antigen, ADCTA
ADCTA is an individualized cell immunotherapy co-culturing autologous dendritic cells derived from peripheral blood mononuclear cells (PBMNCs) with autologous tumor cell as antigen in order to evoke specific immune response.

Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital, Chiayi branch Chiayi City
Taiwan Chang Gung Memorial Hospital, Kaohsiung branch Kaohsiung City
Taiwan Chang Gung Memorial Hospital, Keelung branch Keelung
Taiwan Taichung Veterans General Hospital Taichung City
Taiwan Chi Mei Medical Center Tainan City
Taiwan National Cheng Kung University Hospital Tainan City
Taiwan Chang Gung Memorial Hospital, Linkou branch Taoyuan City

Sponsors (1)

Lead Sponsor Collaborator
Safe Save Medical Cell Sciences & Technology Co.,Ltd.

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Chang CN, Huang YC, Yang DM, Kikuta K, Wei KJ, Kubota T, Yang WK. A phase I/II clinical trial investigating the adverse and therapeutic effects of a postoperative autologous dendritic cell tumor vaccine in patients with malignant glioma. J Clin Neurosci. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival (OS) The duration will be calculated from the date of randomization until the date of death from any cause, assessed up to 60 months.
Secondary Progression-free Survival (PFS) The duration will be calculated from the date of randomization until the date of first documented progression according to the modified RANO or date of death from any cause, whichever came first,assessed up to 60 months.
Secondary Progression-free Survival at 6 months (PFS6) The duration will be calculated from the date of randomization to the date of the sixth month.
Secondary 1 and 2-year Survival Rate The duration will be calculated from the date of randomization to the date of the first year and the second year.
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