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RAG-01 Monotherapy and Combination in NMIBC
NCT07777848Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Sep 2026
- Primary completion
- Mar 2029
- Countries
- 1
- Sponsor
- Ractigen Therapeutics
- Drugs
- RAG-01
- Conditions
- non-muscle-invasive bladder cancer (NMIBC)
01
Overview
Phase 2, randomised trial of RAG-01 in non-muscle-invasive bladder cancer (NMIBC) (4 cohorts), sponsored by Ractigen Therapeutics. Primary endpoint: Efficacy of RAG-01 at 24 months. Planned start Sep 2026; status: not yet recruiting.
02
Design
4 arms- Study design
- Randomized
Cohort A: Safety Lead-in
High-risk NMIBC patients receiving RAG-01 monotherapy or combination in a safety lead-in phase.
Cohort A: RAG-01 Monotherapy
High-risk NMIBC patients randomized to receive RAG-01 monotherapy.
Cohort A: RAG-01 + Chemotherapy
High-risk NMIBC patients randomized to receive RAG-01 plus a chemotherapy agent.
Cohort B: RAG-01 Monotherapy
Intermediate-risk NMIBC patients receiving RAG-01 monotherapy.
03
Who it enrols
Adults with intermediate or high-risk NMIBC (predominantly urothelial carcinoma), BCG-intolerant/ineligible/unwilling, ECOG <= 1, adequate organ function. Excludes low/very high-risk NMIBC, T2+ tumors, recent antitumor therapy, prior specific targeted therapies, recent major surgery, active infections, and severe cardiovascular/renal/pulmonary diseases.
04
Endpoints
Primary
Efficacy of RAG-01
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