Actively Recruiting
T Cells and Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma
Led by Queensland Institute of Medical Research · Updated on 2024-05-31
58
Participants Needed
4
Research Sites
203 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
The goal of this clinical trial is to test a combined therapy approach (allogeneic cytomegalovirus \[CMV\]-specific T cells and pembrolizumab) in patients with brain cancer. The type of brain cancer being studied is glioblastoma multiforme/astrocytoma grade 4. The purpose of part 1 of this study is to determine the maximum-tolerated dose and/or recommended dose(s) for future exploration of allogeneic CMV-specific T cells as monotherapy or in combination with pembrolizumab in patients with recurrent GBM/astrocytoma grade 4. Part 2 of the study aims to investigate the anti-tumour activity of allogeneic CMV-specific T cells as monotherapy or in combination with pembrolizumab, assessed by magnetic resonance imaging and survival, in patients with recurrent or newly diagnosed GBM/grade 4 astrocytoma.
CONDITIONS
Official 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 confirmed diagnosis of glioblastoma multiforme or astrocytoma grade 4
- For recurrent cases, first disease progression confirmed by imaging at least 12 weeks after radiation therapy
- For newly diagnosed cases, willing to delay standard chemotherapy until after T-cell therapy
- Male participants agree to contraception during treatment and 180 days after last dose
- Female participants must not be pregnant or breastfeeding and follow contraceptive guidance if of childbearing potential
- Provide written informed consent
- Recovery to Grade 1 or baseline from previous anti-cancer therapy side effects
- First measurable disease progression based on modified RANO criteria
- Positive CMV serology
- Consent for use of tumor tissue samples
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy of at least 6 months
- Adequate organ function within 10 days before treatment
- Availability of HLA-matched allogeneic CMV-specific T cells
- Consent to access Medicare and Pharmaceutical Benefits Scheme data (phase II only)
- For hepatitis B positive, must be on antiviral therapy with undetectable viral load
- For hepatitis C history, must have undetectable viral load and completed treatment at least 4 weeks prior
You will not qualify if you...
- Female participants who test positive for pregnancy within 72 hours before treatment
- Prior treatment with anti-PD-1, anti-PD-L1, or similar agents
- Systemic anti-cancer or investigational therapy within 4 weeks before study treatment, except temozolomide
- Not recovered from radiation-related toxicities or radiation pneumonitis (recurrent cohort only)
- Live vaccine within 30 days before treatment
- Investigational agent or device within 4 weeks before treatment
- Immunodeficiency or on high-dose steroids or immunosuppressive therapy within 7 days before treatment
- Active progressing malignancy requiring treatment within past 5 years (exceptions apply)
- Previous recurrence of GBM or astrocytoma grade 4 with further progression
- Severe hypersensitivity to pembrolizumab or its excipients
- Active autoimmune disease requiring systemic treatment in past 2 years (except replacement therapy)
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- Known HIV infection
- Concurrent active hepatitis B and C infection
- Not recovered from major surgery or ongoing surgical complications
- Conditions or therapies interfering with study participation or results
- Psychiatric or substance-abuse disorders interfering with study cooperation
- Pregnant, breastfeeding, or planning to conceive/father children during study and 120 days after
- History of allogeneic tissue/solid organ or stem cell transplant
- Baseline corrected QT interval (QTc) over 450 ms on ECG screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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