A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer

NCTID	NCT06545955 (View at clinicaltrials.gov)
Description	The pivotal phase 3 trial (rAd-IFN-CS 003) evaluating the efficacy of nadofaragene firadenovec showed that 55 (53.4%) of 103 subjects with CIS ± high-grade Ta/T1 achieved a complete response (CR) at 3 months. In this trial, the safety and efficacy of intravesical instillation of nadofaragene firadenovec alone or in combination with chemotherapy or immunotherapy will be evaluated in participants with NMIBC CIS (± high-grade Ta/T1). (Show More)
Development Status	Approved
Indication	Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
Disease Ontology Term	DOID:7371; DOID:9053
Compound Name	ADSTILADRIN
Compound Alias	nadofaragene firadenovec
Compound Description	rAd-IFNα/Syn3
Sponsor	Ferring Pharmaceuticals
Funder Type	Industry
Recruitment Status	Recruiting (Click here for study contact information)
Enrollment Count	150
Results Posted	Not Available

Target Gene/Variant	IFNa2b
Therapy Type	Gene transfer
Therapy Route	In-vivo
Mechanism of Action	Overexpression of protective allele/gene
Route of Administration	Intravesicular
Drug Product Type	Viral vector
Target Tissue/Cell
Delivery System	Viral transduction
Vector Type	Ad5
Editor Type
Dose 1	Dose: 3E11 vp/ml, volume: 75ml, frequency: every 3 months
Dose 2
Dose 3
Dose 4
Dose 5

No.of Trial Sites	10
Locations	United States

Has US IND	True
FDA Designations
Recent Updates	FDA approved on 12/16/22 for the treatment of adult patients with high-risk Bacillus Calmette-GuÃÂÃÂÃÂÃÂ©rin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.