Safety & Efficacy of DC Vaccine and TMZ for the Treatment of Newly-diagnosed Glioblastoma After Surgery

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

July 30, 2021

Primary Completion Date

April 30, 2024

Study Completion Date

December 31, 2028

Conditions
Glioblastoma Multiforme of Brain
Interventions
BIOLOGICAL

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

DRUG

Temozolomide adjuvant chemotherapy

Temozolomide is administered as the standard-of-care adjuvant chemotherapy, in combination with the DC vaccines to treat the enrolled patients.

Trial Locations (1)

100730

Beijing Tiantan Hospital, Beijing

All Listed Sponsors
collaborator

ZhongSheng BioTech Inc.

UNKNOWN

lead

Beijing Tiantan Hospital

OTHER

NCT04968366 - Safety & Efficacy of DC Vaccine and TMZ for the Treatment of Newly-diagnosed Glioblastoma After Surgery | Biotech Hunter | Biotech Hunter