Actively Recruiting
Safety, Tolerability, and Preliminary Efficacy of KD01 Via Intravesical Instillation in Bladder Cancer (BC)
Led by Tongji Hospital · Updated on 2026-01-22
29
Participants Needed
1
Research Sites
216 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Recombinant oncolytic adenovirus injection (KD01) is an oncolytic virus product. Its main component is a conditionally replicative recombinant human type 5 adenovirus, where part of the E3 region has been replaced with the gene encoding the tBid apoptotic protein.AK104 is a humanized bispecific antibody co-targeting PD-1 (Programmed Cell Death Protein 1) and CTLA-4 (Cytotoxic T-Lymphocyte-Associated Antigen 4)-two key immune checkpoint receptors. It is designed as a novel tetrameric construct that preferentially binds to tumor-infiltrating lymphocytes (TILs) co-expressing PD-1 and CTLA-4 in the tumor microenvironment (with higher avidity than in peripheral tissues).This is a Phase I clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of intravesical instillation of recombinant oncolytic adenovirus injection (KD01) in patients with bladder cancer.This study consists of Phase Ia and Phase Ib, where Phase Ia is a dose-escalation stage.The Phase Ia will include histopathologically confirmed non-muscle-invasive bladder cancer (NMIBC) patients with high-risk stratification (including extremely high-risk).The Phase Ib study will include two independent cohorts: Cohort A comprises high-risk non-muscle-invasive bladder cancer (NMIBC) patients (carcinoma in situ \[CIS\], with or without Ta/T1 stage lesions) who have shown no response to BCG. Cohort B will include T2-4aN0-1M0 stage bladder cancer patients (clinically localized muscle-invasive bladder urothelial carcinoma).
CONDITIONS
Official Title
Safety, Tolerability, and Preliminary Efficacy of KD01 Via Intravesical Instillation in Bladder Cancer (BC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed non-muscle-invasive bladder cancer (NMIBC) patients with high-risk stratification, including carcinoma in situ (CIS), stage T1, tumor diameter >3 cm, multiple tumors, or recurrent tumors for Phase Ia.
- BCG unresponsive NMIBC patients with CIS, with or without Ta/T1 lesions for Phase Ib Cohort A.
- Histopathologically confirmed muscle-invasive bladder cancer (cT2-4aN0-1M0) patients for Phase Ib Cohort B.
- Medically ineligible for radical cystectomy or declined the procedure (except Phase Ib Cohort B).
- Age between 18 and 75 years inclusive.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1.
- Estimated survival time of 2 years or more.
- No major organ dysfunction including adequate hematopoietic, cardiac, pulmonary, hepatic, and renal function.
- Premenopausal patients must have a negative pregnancy test and agree to reliable contraception during the trial and for 6 months after last dose.
- Patients must provide informed consent and sign a written consent form before participation.
You will not qualify if you...
- Evidence of metastatic disease or multiple regional lymph node involvement at screening.
- Pelvic external beam radiation therapy within the past 5 years.
- Prior treatment with adenovirus-based therapies.
- Symptomatic urinary tract infection or bacterial cystitis (unless treated).
- Significant unexplained elevation of liver or kidney function tests.
- Pregnant or breastfeeding women or those refusing contraception; males unwilling to use effective contraception.
- History of other malignancies within 5 years that may interfere with study.
- Inability to tolerate intravesical instillation for 1 hour or bladder surgery.
- Anti-tumor treatments within 4 weeks before first study drug administration (specific drugs have longer exclusion periods).
- Severe cardiovascular or cerebrovascular diseases including severe arrhythmias, recent serious heart events, uncontrolled hypertension.
- Autoimmune diseases, immune dysfunction, or organ transplantation.
- Active infection requiring systemic therapy or unexplained fever >38.5°C.
- Positive HIV or active hepatitis B or C infections not controlled.
- Uncontrolled seizures, CNS disorders, or psychosis.
- Unresolved severe adverse reactions from prior anti-tumor treatments.
- Current or recent antiviral therapy within 2 weeks before trial drug use.
- Live virus vaccine within 4 weeks before study drug administration.
- Recent systemic glucocorticoids or immunosuppressive treatments within 14 days (with exceptions).
- Severe allergy history or allergic constitution.
- History of allogeneic hematopoietic stem cell or organ transplantation.
- Other conditions deemed unsuitable by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430074
Actively Recruiting
Research Team
Z
Zheng Liu, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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