None listed
Conditions
Brief summary
This study is assessing the safety and tolerability of using T cell therapy targeting human cytomegalovirus (CMV) in treating brain cancer (glioblastoma multiforme). Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with primary glioblastoma multiforme, and have human cytomegalovirus (CMV)-positive serology or positive staining for CMV in tumour tissue. Study details A blood sample will be taken from patients in order to grow the cells for the experimental therapy. These cells, known as T cells (a type of white blood cell) will be grown in the laboratory from each patient’s blood sample. Following generation of the T cell therapy, the participants will commence T cell infusions. The specific timing of each infusion will be dependent on the participants’ chemotherapy regimen. Treatment consists of 2 to 6 infusions (each taking 5-15 min) of T cells, and patients are monitored for 12 months afterwards to see if the treatment is safe. It is hoped that the development of an immunotherapy as an adjuvant to standard chemotherapy and radiotherapy will reduce the rate of tumour recurrence in patients with glioblastoma multiforme.
Interventions
Participants who meet the trial eligibility criteria following screening and review of blood test results will donate a 250-300 mL blood sample.
The investigational product is autologous CMV-specific T cells, stimulated with autologous peripheral blood mononuclear cells (PBMC) coated with synthetic CMV epitopes. Approximately 200-400mL will be collected from eligible participants in order to generate the investigational product.
GBM patients will be given up to six infusions every 2 - 4 week
Participants who meet the trial eligibility criteria following screening and review of blood test results will donate a 250-300 mL blood sample. The investigational product is autologous CMV-specific T cells, stimulated with autologous peripheral blood mononuclear cells (PBMC) coated with synthetic CMV epitopes. Approximately 200-400mL will be collected from eligible participants in order to generate the investigational product. GBM patients will be given up to six infusions every 2 - 4 weeks of 1-2 × 10^7/m^2 autologous CMV-specific T cells. The timing of adoptive transfers will be at the discretion of the clinical investigator, based on the patient’s chemotherapy schedule, and the number of cells infused is based on the height and weight of the patient and the number of cells grown. The cells will be thawed into 20 mL saline, and will be administered to patients intravenously. The T cells will be administered to the patient over 5–15 min by Prof Walker or an appropriately trained delegate. This will allow the slow administration of T cells into the blood. Participants will be followed up to 1 year from the final cell infusion.
Sponsors
QIMR Berghofer Medical Research Institute
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or above 2. Ability to provide informed consent. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at time of screening 4. Life expectancy of at least 6 months 5. Histological diagnosis of primary GBM (WHO grade IV) 6. CMV-positive serology or positive staining for CMV in tumour tissue
Exclusion criteria
1. Markers of active HBV, HCV, HIV, HTLV I and II or syphilis infection* (presence of HbsAg, HCV antibody, HIV antibody, antibodies to HTLV I and II and positive serological test for syphilis, or positive nucleic acid testing [NAT] for HIV, HBV or HCV) 2. Significant non-malignant disease (e.g. severe cardiac or respiratory dysfunction) 3. Psychiatric, addictive or any conditions that may compromise the ability to participate in this trial, as assessed by the Clinical Investigator 4. Prior cancers, except those diagnosed >5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of <5%, or successfully treated non-melanoma skin cancer, or carcinoma in situ of the cervix. 5. Receiving immunosuppressive therapy, except dexamethasone as given for normal management of symptoms related to the brain tumour and its treatment 6. Women who are pregnant, lactating, or unwilling to use adequate contraception * N.B. Positive serology for HBV indicating previous but cleared infection with HBV is not an exclusion criterion.
Outcome results
None listed