Status:
RECRUITING
A Study Evaluating Temferon in Patients with Glioblastoma & Unmethylated MGMT
Lead Sponsor:
Genenta Science
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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 hematopo...
Detailed Description
This is a non-randomized, open label, multicenter, phase I/IIa, therapeutic-exploratory, dose escalation, prospective study, involving a single injection of Temferon, an investigational ATMP consistin...
Eligibility Criteria
Inclusion
- 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 \> 95% in room air);
- Serum creatinine \< 2x upper limit normal and estimated glomerular filtration rate (eGFR) ≥ 30ml/min/1.73m\^2;
- Alkaline phosphatase (ALP), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN), and total bilirubin ≤ 2.0 mg/dl.
- Hemoglobin ≥10 g/dL, platelet count ≥100000/mm\^3, absolute neutrophil count \>1500/mm\^3.
Exclusion
- Use of other investigational agents or procedures within 4 weeks prior to study enrolment (within 6 weeks if use of long-acting agents) or participation in a previous gene therapy study.
- Known hypersensitivity to carmustine (or any other nitrosurea), busulfan, thiotepa, lenograstim, plerixafor, or any excipients used in these products.
- Receipt of any oral or parenteral chemotherapy or immunotherapy within 2 years of Screening.
- Previous allogeneic bone marrow transplantation, kidney or liver transplant.
- Clinical evidence of persistent raised intracranial pressure following surgical resection.
- Clinically relevant active viral, bacterial, or fungal infection at eligibility evaluation.
- Active autoimmune disease or a relevant history of important autoimmune manifestations, in particular psoriasis, systemic lupus erythematosus (SLE), rheumatoid arthritis, vasculitis, immunemediated peripheral neuropathies.
- History of sarcoidosis.
- History or current evidence of neuropsychiatric illness including depression, schizophrenia, bipolar disorders, impaired cognitive function, dementia or suicidal tendency.
- History of severe cardiovascular disease such as prior stroke, coronary artery disease requiring intervention or unresolved arrhythmias in the past 6 months.
- Evidence of any hematological neoplasm.
- Positivity for human immunodeficiency virus type 1 or 2 (HIV-1, HIV-2) (serology or RNA), and/or Hepatitis B Virus Surface Antigen (HbsAg) and/or Hepatitis B Virus (HBV) DNA and/or Hepatitis C virus (HCV) RNA (or negative HCV RNA but on antiviral treatment) and/or Treponema Pallidum or Mycoplasma active infection.
- Active alcohol or substance abuse within 6 months of the study.
- Current pregnancy or lactation.
- Known bleeding diathesis or history of abnormal bleeding, or any other known coagulation abnormalities that would contraindicate lumbar puncture for CSF or future surgery.
- Use of immunosuppressants with the exception of steroids. The maximum permitted dexamethasone (or equivalent) dose is 4 mg per day.
Key Trial Info
Start Date :
March 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 9 2025
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03866109
Start Date
March 5 2019
End Date
December 9 2025
Last Update
January 6 2025
Active Locations (3)
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1
Ospedale San Raffaele
Milan, Italy, 20132
2
Fondazione IRCCS Istituto Neurologico "Carlo Besta"
Milan, Italy, 20133
3
Policlinico Universitario Fondazione Agostino Gemelli
Rome, Italy