A Study Evaluating Temferon in Patients With Glioblastoma & Unmethylated MGMT (NCT03866109) | Clinical Trial Compass
TerminatedPhase 1/2
A Study Evaluating Temferon in Patients With Glioblastoma & Unmethylated MGMT
Stopped: LVLP (pt GBM-01034) took place on 27may2026. The 2 remaining slots allocated by the protocol for the additional cohort to generate safety data prior to study Part B will not be filled. No safety concerns. Benefit-risk profile unchanged.
Italy25 participantsStarted 2019-03-05
Plain-language summary
This is a non-randomized, open label, phase I/IIa, dose-escalation study, involving a single injection of Temferon, an investigational advanced therapy consisting of autologous CD34+-enriched hematopoietic stem and progenitor cells exposed to transduction with a lentiviral vector driving myeloid specific interferon-alpha2 expression, which will be administered to up to 27 patients affected by GBM who have an unmethylated MGMT promoter. Part A will evaluate the safety and tolerability of 5 escalating doses of Temferon and 3 different conditioning regimens in up to 27 patients, following first line treatment.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed, newly diagnosed supratentorial glioblastoma with unmethylated MGMT gene promoter.
* Patients have undergone complete or partial tumor resection.
* Able and willing to provide written informed consent and comply with the study protocol and procedures.
* Eligible for radiotherapy.
* Life expectancy of 6 months or more at Screening.
* Women of child-bearing potential enrolled in the study must have a negative pregnancy test at screening and agree to use acceptable methods of contraception during the trial.
* Men enrolled in the study with partners who are women of child-bearing potential, must be willing to use an acceptable barrier contraceptive method during the trial or have undergone successful vasectomy at least 6 months prior to entry into the study. Successful vasectomy needs to have been confirmed by semen analysis.
* Karnofsky performance score (KPS)≥70.
Additional inclusion criteria to be assessed within 20 days of Temferon administration:
* Adequate cardiac, renal, hepatic and pulmonary function as evidenced by:
* Left ventricular ejection fraction (LVEF) ≥ 45% by echo and normal electrocardiogram (ECG) or presence of abnormalities not significant for cardiac disease.
* Absence of severe pulmonary hypertension;
* Diffusing capacity of the lung for carbon monoxide (DLCO) \>50% and forced expiratory volume in 1 sec (FEV1) and forced expiratory vital capacity (FVC) \> 60% predicted (if non cooperative: pulse oximetry \> …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — do you know why it was stopped, and what that means for what we actually learned about Temferon's safety and effectiveness in glioblastoma with unmethylated MGMT?
2Since this was a Phase 1/2 trial focused on measuring tolerability and safety over the first 90 days, does the limited safety data that was collected tell us anything useful about whether Temferon could still be pursued through other studies or expanded access?
3My tumor has unmethylated MGMT, which I know can make standard temozolomide chemotherapy less effective — given that this trial specifically targeted that subgroup, what treatment options do you think are best suited for my situation now that this study is no longer enrolling?
4Are there any other active clinical trials or experimental approaches targeting unmethylated MGMT glioblastoma that you'd recommend I look into, given that this one is no longer an option?
5Since the trial was terminated, is there any published data or investigator report from the Temferon study I should be aware of, and does it change your thinking at all about my treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tolerability and safety of Temferon over the first 90 days following administration as determined by the incidence of adverse events