Actively Recruiting
Phase I/II Trial of Allogeneic CMV-specific T Cells With Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma Multiforme
Led by Queensland Institute of Medical Research · Updated on 2024-05-31
58
Participants Needed
4
Research Sites
91 weeks
Total Duration
On this page
Sponsors
Q
Queensland Institute of Medical Research
Lead Sponsor
C
CUREator
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a combined therapy using allogeneic cytomegalovirus (CMV)-specific T cells and pembrolizumab for patients with glioblastoma multiforme (GBM) or astrocytoma grade 4 brain cancer. This trial aims to find the best dose and study how well these treatments work alone or together in patients with either newly diagnosed or recurrent disease. The study is divided into two parts: dose escalation and expansion to assess safety and anti-tumor activity. The study includes a dose-escalation phase where participants receive increasing doses of CMV-specific T cells alone or with a fixed dose of pembrolizumab to determine recommended doses. After that, two groups of participants with either newly diagnosed or recurrent GBM/astrocytoma will receive the identified doses of T cells and pembrolizumab. Treatments involve four weekly infusions of the T cells followed by up to 18 infusions of pembrolizumab every six weeks. The study may explore additional groups depending on emerging safety and efficacy data. Participants will undergo screening and receive regular infusions over about 26 months. Their response to treatment will be monitored using MRI scans and survival rates, with assessments of progression-free survival, overall survival, and disease control. Safety will be closely tracked through the occurrence of adverse events, laboratory tests, vital signs, and ECGs. Researchers will also evaluate the duration of treatment response and document any confirmed tumor responses during the study.
CONDITIONS
Brief Title
T Cells and Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old with histologically confirmed glioblastoma multiforme or astrocytoma grade 4
- For recurrent cases, first progression confirmed radiologically at least 12 weeks after radiation therapy
- For newly diagnosed cases, willing to delay standard chemotherapy until after T-cell therapy
- Positive cytomegalovirus (CMV) serology
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy of at least 6 months
- Adequate organ function as assessed within 10 days before treatment
- Availability of HLA-matched allogeneic CMV-specific T cells
- Agree to use contraception during treatment and specified periods after
- Provide informed consent and consent for tissue use and health information access
- Recovered from previous cancer therapy side effects to grade 1 or baseline
- Hepatitis B or C positive participants must meet specific viral load and treatment criteria
You will not qualify if you...
- Positive pregnancy test or pregnancy in women of childbearing potential
- Prior therapy with anti-PD-1, anti-PD-L1, or similar immune checkpoint inhibitors
- Recent systemic anti-cancer therapy or investigational agents within 4 weeks, except temozolomide
- Unresolved radiation-related toxicities or radiation pneumonitis for recurrent disease participants
- Received live vaccines within 30 days before treatment
- Immunodeficiency or ongoing immunosuppressive therapy exceeding specified doses
- Active infections requiring systemic therapy
- Known HIV infection or concurrent active hepatitis B and C infections
- Additional progressing malignancies requiring treatment within past 5 years
- Severe hypersensitivity to pembrolizumab or its components
- Active autoimmune diseases requiring recent systemic treatment
- History or presence of pneumonitis or interstitial lung disease requiring steroids
- Inadequate recovery from major surgery or ongoing surgical complications
- Psychiatric or substance abuse disorders interfering with trial participation
- Pregnant, breastfeeding, or planning conception during the study period
- Previous allogeneic tissue, solid organ, or stem cell transplant
- Baseline corrected QT interval over 450 ms on ECG screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 months
Participants receive four weekly infusions of allogeneic CMV-specific T cells followed by up to 18 infusions of pembrolizumab administered every 6 weeks.
4 weekly visits for T-cell infusions and up to 18 visits every 6 weeks for pembrolizumab infusions
Duration - Up to 26 months total participation
Participants are monitored for efficacy and safety outcomes including survival, disease progression, and response duration for up to 26 months from treatment start.
Visits according to clinical and imaging assessments schedule
Trial Site Locations
Total: 4 locations
1
Newro Foundation
Bowen Hills, Queensland, Australia, 4006
Actively Recruiting
2
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4006
Not Yet Recruiting
3
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Not Yet Recruiting
4
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Not Yet Recruiting
Research Team
M
Michelle Neller, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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