A FIH study to investigate the safety and preliminary efficacy of expanded autologous urothelial cells bioprinted during orthotopic neobladder surgery

Other illness

• History of preoperative radiation therapy.
• History of HIV-1, HIV-2, hepatitis B, or hepatitis C
• Another active malignant disease.
• History of chronic inflammatory bowel disease.
• Detection of a mutation or combination of mutations in any of the 25 genes included in the bladder cancer assay kit

Lab values

• Any medical condition or laboratory abnormality during the Screening Period that, in the opinion of the Investigator, is clinically significant and could interfere with the participant's ability to be included in the study.
• Severely impaired liver or renal function 1. Severe renal impairment is defined as eGFR <50 mL/min/1.73 m². 2. Severe hepatic impairment is defined as the presence of any of the following: total bilirubin >2.5 mg/dL, albumin <3.5 g/dL, INR or prothrombin time >1.7, presence of ascites, or presence of hepatic encephalopathy.

Other

• Diagnosis of upper tract urothelial carcinoma (UTUC) or presence of the following aggressive histological variants of urothelial carcinoma: 1. plasmacytoid, signet ring; 2. lymphoepithelioma-like; 3. giant cell, diffuse, undifferentiated; 4. sarcomatoid urothelial carcinoma; 5. pure neuroendocrine carcinoma (including small and large cell NE carcinomas; 6. pure adenocarcinoma; 7. pure squamous carcinoma
• Poor cognitive function that might impair the patient’s ability to manage continence or self-catheterize if needed.
• Breastfeeding or pregnant women and women seeking to become pregnant.
• Presence of urethral stricture and urethral sphincter incontinence.

• Male and female patients aged 18 to 75 years.
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
• A minimum life expectancy of at least one year.
• Histologically confirmed diagnosis of bladder urothelial carcinoma prior to any treatment
• Disease confirmed as muscle invasive bladder cancer (MIBC) and staged from pT2cN0M0 to pT4acN0M0 according to Tumor, Node, Metastasis (TNM) Classification (2026, 9th edition).
• Eligible radical cystectomy followed by orthotopic ileal neobladder surgery
• Provision of signed Informed Consent.