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Glioblastoma MultiformePhase 1/2TCaPNCT06157541

T Cells and Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma

A Phase 1/2 study testing Allogeneic cytomegalovirus-specific T cells and Pembrolizumab in people with Glioblastoma Multiforme and Astrocytoma, Grade IV, run by Queensland Institute of Medical Research at 4 sites in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Allogeneic cytomegalovirus-specific T cells and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
4 sitesAustralia
Study dates
8 Feb 2024to Jan 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years of age on the day of signing informed consent, with histologically confirmed diagnosis of GBM or astrocytoma Grade 4^.
  • For participants with recurrent GBM or astrocytoma grade 4, histological confirmation of primary diagnosis is available i. First occurrence of disease progression with radiological confirmation ≥12 weeks from completion of radiation therapy.
  • Where surgical resection of recurrent disease occurred, histological confirmation of GBM or astrocytoma Grade 4 is required.
  • For participants with newly diagnosed GBM or astrocytoma Grade 4, histological confirmation of diagnosis is required i. Participant, in consultation with their treating clinicians, is willing to delay the commencement of standard of care adjuvant temozolomide until the completion of CMV-specific T cell therapy infusions.
  • ^Note: Histological confirmation using the 2016 or 2021 World Health Organization (WHO) Classification of Tumours of the central nervous system (CNS) is acceptable and classification edition will be noted.
  • Male participants: Must agree to use contraception during the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period.
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  • Female participants: Must not be pregnant or undergoing in vitro fertilisation or breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) OR
  • A WOCBP who agrees to follow contraceptive guidance during the treatment period and for at 120 days after the last dose of study treatment.
  • Provision of written informed consent for the trial. Approved interpreters will be used for patients who do not have sufficient understanding of English for informed consent to be obtained without an interpreter.
  • Participants who have AEs due to previous anti-cancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible. Participants with >Grade 1 adverse events (AEs) due to previous anti-cancer therapies may be allowed to enrol on a case-by-case basis in discussion with the study Sponsor, if it is determined that it will not put the participant at a higher risk of study-related AEs or interfere with the integrity of the study outcome.
  • In phase II of the trial, participants with disease progression must have measureable disease based on modified RANO criteria. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • CMV-positive serology
  • Provision of consent for the use of archival formalin-fixed, paraffin embedded or fresh tumour tissue obtained at the time of surgical resection or excisional biopsy.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
  • Have a life expectancy of at least 6 months.
  • Have adequate organ function. Specimens must be collected within 10 days prior to the start of study intervention.
  • Have availability of an human leukocyte antigen (HLA)-matched batch of allogeneic CMV-specific T cells.
  • Provision of consent to access to Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) patient/provider health information collected by Services Australia (phase II participants only).
  • Criteria for known hepatitis B and C positive participants:
  • Hepatitis B and C screening tests are not required unless:
  • Known history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • As mandated by local health authority
  • 14.1 Hepatitis B-positive participants:
  • Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks and have undetectable HBV viral load prior to enrolment.
  • Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention
  • 14.2 Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.
  • Participants must have completed curative anti-viral therapy at least 4 weeks prior to enrolment.

Who cannot join

  • A WOCBP who has a positive urine pregnancy test within 72 hours prior to the first dose of study intervention (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
  • Has received prior systemic anti-cancer therapy or investigational agents within 4 weeks prior to study intervention, with the exception of temozolomide, which is permitted during the trial.
  • Recurrent disease cohorts only: Has not yet recovered from all radiation-related toxicities not requiring corticosteroids other than dexamethasone, or has had radiation pneumonitis.
  • Note: A 1-week washout is permitted for palliative radiation of non-CNS disease (≤2 weeks of radiotherapy). Participants receiving dexamethasone must be clinically stable and receiving a stable or weaning dose of ≤2 mg/day 1-2 weeks prior to the commencement of pembrolizumab.
  • Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines is allowed.
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  • Has received in an investigational agent, or has used an investigational device within 4 weeks prior to the first dose of study intervention.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Known additional malignancy that is progressing or has required active treatment within the past 5 years.
  • Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, prostate cancer treated with radical prostatectomy, or carcinoma in situ, excluding carcinoma in situ of the bladder, who have undergone potentially curative therapy are not excluded. Participants with additional malignancy within the past 5 years may be allowed to enrol on a case-by-case basis, in discussion with the study Sponsor, if the malignancy is deemed of very low recurrence potential and the participant has completed curative intent therapy.
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid).
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has an active infection requiring systemic therapy.
  • Has a known history of human immunodeficiency virus (HIV) infection. Note: No HIV testing is required unless mandated by a local health authority.
  • Concurrent active hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.
  • Note: Hepatitis B and C screening tests are not required unless:
  • Known history of HBV and HCV infection
  • As mandated by local health authority
  • Has not adequately recovered from major surgery or has ongoing surgical complications.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance-abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
  • Has had an allogeneic tissue/solid organ transplant or stem cell transplant.
  • Has a baseline corrected QT interval (QTc) of >450 ms, assessed by ECG. If the participant's screening ECG records a QTc of >450 ms, the ECG is to be done in triplicate and the average of the QTc is to be recorded. If the QTc remains >450 ms, the participant will be excluded from enrolment.

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

  • Newro Foundation

    Bowen Hills, Queensland, 4006

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4006

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

About this study

Official title: Phase I/II Clinical Trial of Allogeneic Cytomegalovirus-specific T Cells in Combination With Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma Multiforme

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.

Read the detailed description

This is a multi-centre, non-randomised, open-label, dose escalation and expansion trial of allogeneic cytomegalovirus (CMV)-specific T cells as monotherapy and in combination with pembrolizumab in participants with recurrent and newly diagnosed glioblastoma multiforme (GBM)/astrocytoma grade 4. The trial will be conducted in two parts.

Part 1 is a single-arm, sequential 3+3 dose-escalation of allogeneic CMV-specific T cells as a monotherapy and in combination with a fixed dose of pembrolizumab to determine the recommended dose(s) for future exploration. Up to 18 participants will be recruited for part 1. Part 2 will involve two arms and will examine the clinical impact of the CMV-specific T cells as monotherapy and in combination with pembrolizumab. Forty participants will be recruited for part 2 - 20 with newly diagnosed GBM/astrocytoma grade 4 and 20 with recurrent GBM/astrocytoma grade 4.

Part 2 will only be initiated if the data and safety monitoring board (DSMB) determines that the proposed dose level(s) for future exploration are safe and well tolerated. Additional groups may be explored depending on emergent safety, pharmacodynamics and/or clinical efficacy data.

Following screening and enrolment, each participant will receive four weekly infusions (Q1W) of allogeneic CMV-specific T cells, followed by up to 18 infusions of pembrolizumab. Pembrolizumab infusions will commence seven days (±3 days) after the final T-cell infusion, and be administered every 6 weeks (Q6W). The total duration of participation for each participant is approximately 26 months.

Efficacy of the combination therapy will be evaluated according to the modified Response Assessment in Neuro-Oncology (RANO) and immunotherapy (i)RANO criteria, through radiographic imaging. For group A and group B the appropriate measures for progression-free survival (PFS), overall survival (OS), disease control rate and duration of response will be assessed.

Being tested
Allogeneic cytomegalovirus-specific T cells, Pembrolizumab
Keywords
immunotherapy, T cells, pembrolizumab, glioblastoma
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allogeneic cytomegalovirus-specific T cellsBiological

    Also called CYT-101

    Allogeneic cytomegalovirus (CMV)-specific T cells generated from the blood of healthy CMV-seropositive donors

  • PembrolizumabDrug

    Also called Keytruda

    A humanised immunoglobulin G4 (IgG4) monoclonal antibody (mAb) specific for the programmed cell death 1 (PD-1) receptor

Study groups in NCT06157541
Study groupRoleWhat they receive
Part 1ExperimentalPatients with recurrent disease. Interventions: * allogeneic CMV-specific T cells (cell suspension for infusion), dose cohorts: 2 × 10^7 cells, 4 × 10^7 cells, 8 × 10^7 cells; 4 infusions; administered weekly * pembrolizumab 400 mg (solution for injection); 18 infusions; administered every 6 weeks
Receives: Biological: Allogeneic cytomegalovirus-specific T cells; Drug: Pembrolizumab
Part 2 Group AExperimentalPatients with recurrent disease. Interventions: * allogeneic CMV-specific T cells (cell suspension for infusion), maximum-tolerated dose identified in phase I; 4 infusions; administered weekly * pembrolizumab 400 mg (solution for injection); 18 infusions; administered every 6 weeks
Receives: Biological: Allogeneic cytomegalovirus-specific T cells; Drug: Pembrolizumab
Part 2 Group BExperimentalPatients with newly diagnosed disease. Interventions: * allogeneic CMV-specific T cells (cell suspension for infusion), maximum-tolerated dose identified in phase I; 4 infusions; administered weekly * pembrolizumab 400 mg (solution for injection); 18 infusions; administered every 6 weeks
Receives: Biological: Allogeneic cytomegalovirus-specific T cells; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose-limiting toxicities

    Part 1 - Primary Endpoint 1

    Measured: Within 49 days of receiving the first dose of study drug

  2. Incidence of adverse events and clinically significant changes in laboratory parameters, vital signs, and electrocardiograms (ECGs)

    Part 1 - Primary Endpoint 2

    Measured: Within 49 days of the first dose of study drug

  3. Percentage of participants with confirmed complete response (CR) or partial response (PR)

    Part 2 - Primary Endpoint 1

    Measured: Within 25 months of the first dose of study drug

  4. Percentage of participants with confirmed complete response (CR), partial response (PR), or stable disease (SD)

    Part 2 - Primary Endpoint 2

    Measured: Within 25 months of the first dose of study drug

  5. Duration of response

    Part 2 - Primary Endpoint 3

    Measured: Within 25 months of the first dose of study drug

  6. Overall survival (percentage of participants alive)

    Part 2 - Primary Endpoint 4

    Measured: 6 months

  7. Progression-free survival (percentage of participants with no evidence of further disease progression)

    Part 2 - Primary Endpoint 5

    Measured: 6 months

Secondary outcomes (3)

  1. Overall survival (percentage of participants alive)

    Part 1 - Secondary Endpoint 1

    Measured: 6 months

  2. Progression-free survival (percentage of participants with no evidence of further disease progression)

    Part 1 - Secondary Endpoint 2

    Measured: 6 months

  3. Incidence of adverse events and clinically significant changes in laboratory parameters, vital signs, and ECGs

    Part 2 - Secondary Endpoint 1

    Measured: Within 25 months of the first dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2023
  2. Study start8 Feb 2024
  3. Primary completion2 Oct 2025
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Phase I of the trial is a 3+3 dose escalation study involving 9-18 participants. Phase II will recruit two cohorts of 20 participants.
Masking
None (open label)
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06157541
Sponsor's protocol ID
P3894 / MSD-MK3475-E78
Acronym
TCaP
Status last verified
Jun 2026
First submitted
26 Nov 2023
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Allogeneic cytomegalovirus-specific T cells and Pembrolizumab in people with Glioblastoma Multiforme and Astrocytoma, Grade IV, run by Queensland Institute of Medical Research at 4 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicities (time frame: Within 49 days of receiving the first dose of study drug). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06157541.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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