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Clinical Trial Report

Gene Therapy Trial Report

Summary

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
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
Enrollment Count 150
Results Posted Not Available

Therapy Information


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

Study Record Dates


Current Stage Phase2
Submit Date 2024-08-06
Completion Date 2030-12-31
Last Update 2025-04-23

Participation Criteria


Eligible Age >=18 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

Locations


No.of Trial Sites 10
Locations United States

Regulatory Information


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-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Resources/Links