A Study Evaluating Temferon in Patients With Glioblastoma & Unmethylated MGMT (NCT03866109) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study Evaluating Temferon in Patients With Glioblastoma & Unmethylated MGMT
Italy27 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 range18 Years – 70 Years
SexALL
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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 \> …
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