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NCT03866109: TEM-GBM
A Study Evaluating Temferon in Patients With Glioblastoma & Unmethylated MGMT
Phase 1, PHASE2 trial testing Temferon in Glioblastoma Multiforme in 27 participants. Participants enrolled and being followed up; not accepting new ones.
30 June 2026
Quick facts
| Lead sponsor | Genenta Science |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 5 March 2019 |
| Primary completion | 30 June 2026 |
| Estimated completion | 30 June 2026 |
| Sites | 3 locations across Italy |
Drugs / interventions tested
- Temferon — full drug profile →
Conditions studied
- Glioblastoma Multiforme — all drugs for Glioblastoma Multiforme →
Sponsor
Genenta Science — full company profile →
Who can join
Adults 18 to 70, any sex, with Glioblastoma Multiforme. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Macrophages as tools and targets in cancer therapy.
Mantovani A, Allavena P, Marchesi F, Garlanda C. · · 2022 · cited 1279× · PMID 35974096 · DOI 10.1038/s41573-022-00520-5 -
Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7 -
Macrophages and microglia: the cerberus of glioblastoma.
Buonfiglioli A, Hambardzumyan D. · · 2021 · cited 184× · PMID 33766119 · DOI 10.1186/s40478-021-01156-z -
Exploiting innate immunity for cancer immunotherapy.
Yi M, Li T, Niu M, Mei Q, et al · · 2023 · cited 151× · PMID 38008741 · DOI 10.1186/s12943-023-01885-w -
Glioblastoma Immune Landscape and the Potential of New Immunotherapies.
Daubon T, Hemadou A, Romero Garmendia I, Saleh M. · · 2020 · cited 89× · PMID 33154756 · DOI 10.3389/fimmu.2020.585616 -
Targeting of TAMs: can we be more clever than cancer cells?
Kzhyshkowska J, Shen J, Larionova I. · · 2024 · cited 79× · PMID 39516356 · DOI 10.1038/s41423-024-01232-z -
Current Approaches for Glioma Gene Therapy and Virotherapy.
Banerjee K, Núñez FJ, Haase S, McClellan BL, et al · · 2021 · cited 70× · PMID 33790740 · DOI 10.3389/fnmol.2021.621831 -
Tumor-associated macrophage-related strategies for glioma immunotherapy.
Tang F, Wang Y, Zeng Y, Xiao A, et al · · 2023 · cited 57× · PMID 37598273 · DOI 10.1038/s41698-023-00431-7
Verify or expand the search:
- PubMed search for NCT03866109
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Temferon
Trials testing the same drug.
- NCT06716853 — A Clinical Gene Therapy Study With Hematopoietic Stem Cells for the Treatment, With Single Dose of Temferon, of Patients · Phase 1, PHASE2 · terminated
- NCT03875495 — A Phase I/II Study Evaluating Temferon in Multiple Myeloma Patients With Early Relapse After Front Line Therapy (TEM-MM) · Phase 1, PHASE2 · terminated
Other recruiting trials for Glioblastoma Multiforme
Currently open trials in the same condition.
- NCT06466031 — Application of FET-PET in Fusion With MRI in the Treatment of Glioblastoma Multiforme [TYR-GLIO] · NA · recruiting
- NCT06333899 — Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion · EARLY_PHASE1 · recruiting
- NCT05956821 — Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age · Phase 1, PHASE2 · recruiting
- NCT06496971 — A Prospective Pivotal Study to Evaluate the Efficacy and Safety of Avastin® Bevacizumab (BEV) With or Without Microbubbl · Phase 3 · recruiting
- NCT06329570 — Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multif · Phase 1, PHASE2 · recruiting
Other Genenta Science trials
Trials by the same sponsor.
- NCT06716853 — A Clinical Gene Therapy Study With Hematopoietic Stem Cells for the Treatment, With Single Dose of Temferon, of Patients · Phase 1, PHASE2 · terminated
- NCT03875495 — A Phase I/II Study Evaluating Temferon in Multiple Myeloma Patients With Early Relapse After Front Line Therapy (TEM-MM) · Phase 1, PHASE2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03866109 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Genenta Science
- Last refreshed: 9 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03866109.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing