11
Participants
Start Date
July 30, 2021
Primary Completion Date
April 30, 2024
Study Completion Date
December 31, 2028
Autologous dendritic cells pulsed with multiple neoantigen peptides.
Each dosage of Dendritic Cells (DC) vaccine contains 2-10 million DC cells, loaded with 5-20 tumor neoantigen peptides. DC vaccine will be administered (i.d) around lymph nodes of the groin and Axillary at 2nd, 3rd, 4th, 7th and 11th week after the completion of concurrent Temozolomide chemoradiation. After 5 injections, the investigator will review subject's tolerance and compliance; and, decide whether to administer more DC vaccines up to 8 injections. For certain patients with good tolerance and clinical response of the DC vaccine, peripheral blood is extracted after completion of Temozolomide adjuvant chemotherapy to assess the patient's immune response. According to the result, investigators will decide whether to perform 1-2 more treatment cycles (5-8 injections/cycle) to strengthen the effectiveness
Temozolomide adjuvant chemotherapy
Temozolomide is administered as the standard-of-care adjuvant chemotherapy, in combination with the DC vaccines to treat the enrolled patients.
Beijing Tiantan Hospital, Beijing
ZhongSheng BioTech Inc.
UNKNOWN
Beijing Tiantan Hospital
OTHER