^
    11d
    ABLE-32: Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P3, N=454, Recruiting, Ferring Pharmaceuticals | N=296 --> 454
    Enrollment change
    |
    Adstiladrin (nadofaragene firadenovec-vncg)
    16d
    Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle Invasive Bladder Cancer, TRIFECTA Trial (clinicaltrials.gov)
    P2, N=33, Not yet recruiting, University of Washington | Initiation date: Mar 2026 --> Jun 2026
    Trial initiation date
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • Adstiladrin (nadofaragene firadenovec-vncg)
    1m
    000434: A study to learn about nadofaragene firadenovec given alone or together with gemcitabine and docetaxel or, pembrolizumab in adults with non-muscle invasive bladder cancer and no response to treatment with Bacillus Calmette-Guerin (2024-512177-27-01)
    P2/3, N=143, Recruiting, Ferring Pharmaceuticals A/S
    New P2/3 trial
    |
    Keytruda (pembrolizumab) • gemcitabine • docetaxel • Adstiladrin (nadofaragene firadenovec-vncg)
    1m
    000425: Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to the Renal Pelvis (LUNAR) (2024-514360-70-00)
    P1/2, N=5, Not yet recruiting, Ferring Pharmaceuticals A/S
    New P1/2 trial
    |
    Adstiladrin (nadofaragene firadenovec-vncg)
    1m
    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
    |
    Adstiladrin (nadofaragene firadenovec-vncg)
    2ms
    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
    |
    Keytruda (pembrolizumab) • Cabometyx (cabozantinib tablet) • Temferon (Autologous CD34+ enriched HSPCs expressing interferon-alpha 2)
    2ms
    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)
    3ms
    Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle Invasive Bladder Cancer, TRIFECTA Trial (clinicaltrials.gov)
    P2, N=33, Not yet recruiting, University of Washington
    New P2 trial
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • Adstiladrin (nadofaragene firadenovec-vncg)
    3ms
    The PINNACLE study: A multicentre phase II trial of nilotinib in combination with pegylated interferon-α2b in newly diagnosed chronic phase chronic myeloid leukaemia. (PubMed, Br J Haematol)
    We evaluated the tolerability and efficacy of pegylated interferon alfa-2B (peg-IFNα; PegIntron, MSD) combined with nilotinib in the Australasian Leukaemia and Lymphoma Group CML11 (Pinnacle) study. CML11 demonstrated that peg-IFNα with nilotinib leads to high rates of molecular response, with tolerability similar to prior studies. Trial registration ANZCTRN12612000851864.
    P2 data • Journal
    |
    ABL1 (ABL proto-oncogene 1) • IFNA1 (Interferon Alpha 1)
    |
    nilotinib • ViraferonPeg (peginterferon-α-2b)
    4ms
    TR-002 for the Treatment of Advanced, Unresectable or Metastatic Solid Tumors and Unresectable or Metastatic, Refractory Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P1, N=52, Recruiting, University of California, Davis | Not yet recruiting --> Recruiting | Trial completion date: Dec 2030 --> Feb 2030
    Enrollment open • Trial completion date
    |
    Adstiladrin (nadofaragene firadenovec-vncg)
    4ms
    Gene Therapy for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: Current Evidence and Future Directions. (PubMed, Cancers (Basel))
    Nadofaragene firadenovec, a recombinant adenovirus delivering interferon alpha-2b (IFNα2b), is the first FDA-approved gene therapy for BCG-unresponsive NMIBC with carcinoma in situ (CIS)...Cretostimogene grenadenorepvec (CG0070), an oncolytic vector, demonstrated a 47% 6-month CR rate in a phase II study (NCT02365818). Detalimogene voraplasmid (EG-70), a nonviral gene therapy, demonstrated a 47% 6-month CR in a phase I/II study (NCT04752722). Future advances are likely to focus on patient selection, novel vectors, and combination strategies to improve treatment outcomes. Gene therapy represents a significant addition to the bladder cancer treatment landscape by offering bladder-sparing alternatives where conventional therapies are limited.
    Review • Journal
    |
    IFNA1 (Interferon Alpha 1)
    |
    Adstiladrin (nadofaragene firadenovec-vncg) • cretostimogene grenadenorepvec (CG0070) • detalimogene voraplasmid (EG-70)
    5ms
    iinnovate-1: A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=272, Terminated, Takeda | Completed --> Terminated; Terminated by the sponsor for strategic reasons
    Trial termination
    |
    dexamethasone injection • modakafusp alfa (TAK-573)