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Temferon

Phase 1

Glioblastoma Multiforme | Small molecule | Oncology |Genenta Science S.p.A.|Last Updated: Feb 9, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03866109A Study Evaluating Temferon in Patients With Glioblastoma & Unmethylated MGMTPHASE1 ACTIVE NOT_RECRUITING 27 — — Mar 5, 2019Jun 30, 2026Feb 9, 20263 Italy
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Study Endpoints
Primary Endpoints
Tolerability and safety of Temferon over the first 90 days following administration as determined by the incidence of adverse events
90 days

Routine clinical and laboratory surveillance

Secondary Endpoints
Long term tolerability and safety of Temferon as determined by the incidence of adverse events
2 years
Proportion of patients achieving haematologic recovery by Day +30 (defined as the first of at least 3 consecutive days with a neutrophil count >0.5 x 10^9/L and platelet count >20 x 10^9/L)
30 days
Determine the maximum tolerated dose of Temferon
30 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TemferonEXPERIMENTALAutologous CD34+-enriched hematopoietic progenitor cells exposed in vitro to specific lentiviral vector encoding for the human interferon-alpha 2 gene. Its expression is tightly controlled by the human TIE2 enhancer/promoter sequence and by a post-transcriptional regulation layer represented by target miRNA sequences. This enables suppression of interferon-alpha2 expression in HSPCs, thereby further increasing the specificity of the delivery strategy for their Tie2 expressing myeloid cell progeny.
Interventions
NameTypeDescription
TemferonDRUGGenetically modified HSPCs
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites3

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. ...

Countries:Italy
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Recent Changes (Last 90 Days)
MEDIUMJun 7, 2026NCT03866109Phase: PHASE1/PHASE2 → PHASE1
MEDIUMJun 7, 2026NCT03866109Phase: PHASE1/PHASE2 → PHASE1
MEDIUMJun 7, 2026NCT03866109Phase: PHASE1/PHASE2 → PHASE1
MEDIUMJun 7, 2026NCT03866109Phase: PHASE1/PHASE2 → PHASE1
MEDIUMJun 7, 2026NCT03866109Phase: PHASE1/PHASE2 → PHASE1
MEDIUMJun 7, 2026NCT03866109Phase: PHASE1/PHASE2 → PHASE1
LOWMay 24, 2026NCT03866109studyFirstPostDate: changed