ADCTA for Adjuvant Immunotherapy in Standard Treatment of Recurrent Glioblastoma Multiforme (GBM)

STATUS

Recruiting
participants needed

118
sponsor

Safe Save Medical Cell Sciences & Technology Co.,Ltd.

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Updated on 19 February 2024

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blood transfusion

neutrophil count

bevacizumab

karnofsky performance status

thromboplastin

blood urea nitrogen

aptt

renal function test

temozolomide

glioblastoma multiforme

recurrent glioblastoma

contrast-enhanced magnetic resonance imaging

adjuvant

glioma

supratentorial tumor

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.

Details

Condition	Glioblastoma Multiforme, Glioblastoma Multiforme
Age	18years - 70years
Treatment	Autologous Dendritic Cell/Tumor Antigen, ADCTA
Clinical Study Identifier	NCT04277221
Sponsor	Safe Save Medical Cell Sciences & Technology Co.,Ltd.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Specimen collection screening
	Karnofsky performance status (KPS) 60 at assessment prior to surgery
	and 70 years of age
	Subject has been diagnosed with GBM and has undergone resection surgery followed by standard brain RT + concurrent temozolomide and adjuvant temozolomide, and progression occurred. The foregoing progression is defined as when patients with primary GBM experience an image or clinical deterioration after receiving standard of care
	Contrast-enhanced MRI suspects recurrent GBM
	Supratentorial tumor
	Must voluntarily sign and date informed consent form for specimen acquisition and future use, for study screening, approved by an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any study-specific procedures
	Study screening
	Karnofsky performance status (KPS) 60 at randomization
	Submission of fresh tumor
	Post-operation contrast-enhanced MRI scan must be done after surgical resection, with the intent for cyto-reduction 80% of the contrast-enhancing tumor mass
	Histologically confirmed WHO grade IV glioma by pathology tissue screening
	Subjects receiving bevacizumab as standard of care for given indication
	Subject has adequate bone marrow, renal, and hepatic function prior to randomization as follow
	White blood cell (WBC) count 2,000/mm^3
	Absolute neutrophil count (ANC) 1,000/mm^3
	Platelets 100,000/mm^3
	Hemoglobin (Hgb) 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb 8.0 g/dL is acceptable.)
	Blood Urea Nitrogen (BUN) < 30 mg/dL
	Creatinine < 2 mg/dL
	Renal function: calculated creatinine clearance 30 mL/min
	Hepatic function: Total bilirubin 3 times upper limit of normal (ULN), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) 2 times ULN
	Prothrombin Time (PT) and activated partial thromboplastin time (PTT) 1.6 times ULN unless therapeutically warranted
	Subjects with recurrent GBM (Grade IV) are eligible for this protocol. An independent neuropathologist will review this diagnosis during the enrollment process
	Must voluntarily sign and date informed consent form, for study participation, approved by an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any study-specific procedures
Exclusion Criteria
	Specimen collection screening
	Multifocal GBM
	Prior invasive malignancy (except for non-melanomatous skin cancer; carcinoma in situ of breast, oral cavity or cervix) unless disease free for 2 years
	Subject has used bevacizumab or immune checkpoint blockade to treat GBM
	Lactating or pregnant female
	Positive viral serology for HIV or syphilis at time of screening
	Study screening
	Subjects having a biopsy only at surgery or tumor cell insufficiency at preparation
	Inability to undergo contrast-enhanced MRI scans
	Subjects receiving investigational study drug for any indication or immunological-based treatment for any reason (Filgrastim may be used for prevention of severe neutropenia)
	Inability to stop or decrease the use of corticosteroid doses to 4 mg/day prior to randomization
	Tumor progression documented according to modified RANO criteria prior to randomization (approximately 5 weeks after surgery)
	Severe, active comorbidity, defined as follow
	Subject with clinically defined Acquired Immune-Deficiency Syndrome (AIDS)-defining illness
	Subjects with acute hepatitis C or B infection
	Severe hepatic impairment (Child-Pugh category C or higher)
	Electrocardiogram (ECG) with evidence of acute cardiac ischemia prior to randomization
	Transmural myocardial infarction or ischemia prior to enrollment
	Any other major medical illnesses or psychiatric impairments that in the Investigator's opinion will prevent administration or completion of protocol therapy
	Subject used Gliadel wafer implant in surgery during screening process

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ADCTA for Adjuvant Immunotherapy in Standard Treatment of Recurrent Glioblastoma Multiforme (GBM)