A phase I/IIa dose escalation study evaluating the safety and efficacy of autologous CD34+-enriched hematopoietic progenitor cells genetically modified with a lentiviral vector encoding for the human interferon-a2 in patients with glioblastoma multiforme who have an unmethylated O-6- methylguanine-DNA methyltransferase gene promoter - TEM-GBM

GENENTA SCIENCE SR0 sites21 target enrollmentJune 12, 2019

DrugsMOZOBIL - 20 MG/ML - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) - 24 MG/1.2 ML 1 FLACONCINO MYELOSTIM - 13 1 FLAC LIOF 13.4 MIU + SIR SOLV 1 ML Carmustine TEPADINA -

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: GENENTA SCIENCE SR
Enrollment: 21
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 12, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

GENENTA SCIENCE SR

Eligibility Criteria

Inclusion Criteria

•Inclusion Criteria at Screening:
•Patients aged between 18 and \=70\.
•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.

Exclusion Criteria

•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), 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, immune\-mediated 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.