A study to check whether adding RUTI® to standard BCG treatment for high-risk early-stage bladder cancer is safe and how it changes the body’s defenses, with participants randomly receiving RUTI® or a look-alike treatment.

Status Authorised, recruitment pending · 1 EU/EEA countries · 2 sites · Protocol RJ-RTV-01

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans

Status Authorised, recruitment pending

Participants planned 44

Countries 1

Sites 2

High-risk non-muscle invasive bladder cancer (NMIBC)

Key facts

Sponsor: Laboratorio Reig Jofre S.A.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]
Decision date (initial): 2026-06-18
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

High-risk non-muscle invasive bladder cancer (NMIBC)

Version	Level	Code	Term	System organ class
25.1	LLT	10087823	NMIBC	100000004848

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Laboratorio Reig Jofre S.A.

Sponsor organisation: Laboratorio Reig Jofre S.A.
Address: Avinguda Les Flors S/N
City: Sant Joan Despi
Postcode: 08970
Country: Spain

Scientific contact point

Organisation: Laboratorio Reig Jofre S.A.
Contact name: Alejandra Espinosa Guerrero

Public contact point

Organisation: Laboratorio Reig Jofre S.A.
Contact name: Alejandra Espinosa Guerrero

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
Spain	Authorised, recruitment pending	44	2
Rest of world	—	0	—

Investigational sites

Spain

2 sites · Authorised, recruitment pending

Hospital Germans Trias I Pujol

Urology, Carretera Canyet 1a Planta, 08916, Badalona

Bellvitge University Hospital

Urology, Carrer De La Feixa Llarga S/N, 08907, L'Hospitalet De Llobregat

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2026-04-22	Spain	Acceptable 2026-06-15	2026-06-18