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A Study to Evaluate the Efficacy and Safety of RAG-01 as Monotherapy and in Combination With Chemotherapy in Patients With Non-muscle Invasive Bladder Cancer (NMIBC).

NCT07777848 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2026-08-20

No results posted yet for this study

Summary

This is a randomized, controlled, multicenter clinical study to evaluate the efficacy and safety of RAG-01 monotherapy and in combination with chemotherapy in patients with NMIBC.

Conditions

  • Non-muscle Invasive Bladder Cancer (NMIBC)

Interventions

DRUG

RAG-01

The RAG-01 will be administered as a single agent for evaluation the efficiency in intermediate-risk NMIBC patients.

DRUG

RAG-01 and chemotherapy agent

To evaluate the safety, tolerability, and efficacy of RAG-01 as monotherapy and in combination with a chemotherapy agent in high-risk NMIBC patients, determine the recommended dose, and assess the efficacy of monotherapy and combination therapy.

Sponsors & Collaborators

  • Ractigen Therapeutics.

    lead OTHER

Principal Investigators

  • Dingwei Ye · 270 Dong'an Road, Xuhui District, Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-03-31
Completion
2029-03-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07777848 on ClinicalTrials.gov