^
7d
TEM-GBM: A Study Evaluating Temferon in Patients With Glioblastoma & Unmethylated MGMT (clinicaltrials.gov)
P1/2, N=25, Terminated, Genenta Science | No safety concerns. Benefit-risk profile unchanged.
Trial termination
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MGMT (6-O-methylguanine-DNA methyltransferase)
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Temferon (Autologous CD34+ enriched HSPCs expressing interferon-alpha 2)
10d
Trial initiation date
|
cisplatin • Imfinzi (durvalumab) • gemcitabine • Adstiladrin (nadofaragene firadenovec-vncg)
17d
Tumor-targeted interferon-α gene therapy for glioblastoma: a phase 1 trial. (PubMed, Nat Med)
Twenty-four newly diagnosed patients with GBM and unmethylated MGMT promoter were treated across eight cohorts following surgical resection and radiotherapy, testing Temferon doses ranging from 0.5 × 106 to 4.0 × 106 CD34+ cells kg-1 and different conditioning regimens (BCNU or busulfan, with or without thiotepa). Temferon is a safe and tolerable immunotherapeutic strategy in patients with newly diagnosed GBM. ClinicalTrials.gov: NCT03866109 .
P1 data • Journal • First-in-human
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CD34 (CD34 molecule)
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thiotepa • busulfan • Temferon (Autologous CD34+ enriched HSPCs expressing interferon-alpha 2)
2ms
Trial completion
|
gemcitabine • Adstiladrin (nadofaragene firadenovec-vncg) • celecoxib oral
3ms
Enrollment change
|
Adstiladrin (nadofaragene firadenovec-vncg)
3ms
Trial initiation date
|
cisplatin • Imfinzi (durvalumab) • gemcitabine • Adstiladrin (nadofaragene firadenovec-vncg)
4ms
New P2/3 trial
|
Keytruda (pembrolizumab) • gemcitabine • docetaxel • Adstiladrin (nadofaragene firadenovec-vncg)
4ms
New P1/2 trial
|
Adstiladrin (nadofaragene firadenovec-vncg)
4ms
ABLE-41: ADSTILADRIN Early Utilization and Outcomes in the Real World Setting (clinicaltrials.gov)
P=N/A, N=202, Terminated, Ferring Pharmaceuticals | N=400 --> 202 | Trial completion date: Dec 2027 --> Jan 2026 | Recruiting --> Terminated | Trial primary completion date: Dec 2027 --> Jan 2026; An internal audit identified major inconsistencies and missing data in key registry fields, including primary outcomes. These issues mean we can no longer ensure the validity of the primary endpoints.
Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Real-world evidence
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Adstiladrin (nadofaragene firadenovec-vncg)
4ms
TEM-GU: A Clinical Gene Therapy Study With Hematopoietic Stem Cells for the Treatment, With Single Dose of Temferon, of Patients Suffering From Metastatic Renal Cell Carcinoma (clinicaltrials.gov)
P1/2, N=10, Terminated, Genenta Science | The decision to terminate the study was not based on any safety concerns. Benefit-risk profile of IP unchanged.
Trial completion date • Trial termination • Trial primary completion date
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Keytruda (pembrolizumab) • Cabometyx (cabozantinib tablet) • Temferon (Autologous CD34+ enriched HSPCs expressing interferon-alpha 2)
4ms
TEM-GBM: A Study Evaluating Temferon in Patients With Glioblastoma & Unmethylated MGMT (clinicaltrials.gov)
P1/2, N=27, Active, not recruiting, Genenta Science | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Dec 2025 --> Jun 2026
Enrollment closed • Trial completion date • Trial primary completion date
|
MGMT (6-O-methylguanine-DNA methyltransferase)
|
Temferon (Autologous CD34+ enriched HSPCs expressing interferon-alpha 2)
5ms
New P2 trial
|
cisplatin • Imfinzi (durvalumab) • gemcitabine • Adstiladrin (nadofaragene firadenovec-vncg)