AUROCELL-TX for Muscle-invasive bladder cancer (MIBC)

Inclusion criteria

• {"criterion_text":"- Male and female patients aged 18 to 75 years."}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1."}
• {"criterion_text":"- A minimum life expectancy of at least one year."}
• {"criterion_text":"- Histologically confirmed diagnosis of bladder urothelial carcinoma prior to any treatment"}
• {"criterion_text":"- Disease confirmed as muscle invasive bladder cancer (MIBC) and staged from pT2cN0M0 to pT4acN0M0 according to Tumor, Node, Metastasis (TNM) Classification (2017, 8th edition)."}
• {"criterion_text":"- Eligible radical cystectomy followed by orthotopic ileal neobladder surgery"}
• {"criterion_text":"- Provision of signed Informed Consent."}

Exclusion criteria

• {"criterion_text":"- Diagnosis of upper tract urothelial carcinoma (UTUC) or presence of the following aggressive histological variants of urothelial carcinoma: 1.\tplasmacytoid, signet ring; 2.\tlymphoepithelioma-like; 3.\tgiant cell, diffuse, undifferentiated; 4.\tsarcomatoid urothelial carcinoma; 5.\tpure neuroendocrine carcinoma (including small and large cell NE carcinomas; 6.\tpure adenocarcinoma; 7.\tpure squamous carcinoma"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Poor cognitive function that might impair the patient’s ability to manage continence or self-catheterize if needed."}
• {"criterion_text":"- History of preoperative radiation therapy."}
• {"criterion_text":"- Breastfeeding or pregnant women and women seeking to become pregnant."}
• {"criterion_text":"- Presence of urethral stricture and urethral sphincter incontinence."}
• {"criterion_text":"- History of HIV-1, HIV-2, hepatitis B, or hepatitis C"}
• {"criterion_text":"- Another active malignant disease."}
• {"criterion_text":"- History of chronic inflammatory bowel disease."}
• {"criterion_text":"- Severely impaired liver or renal function 1.\tSevere renal impairment is defined as eGFR <50 mL/min/1.73 m². 2.\tSevere 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."}
• {"criterion_text":"- Detection of a mutation or combination of mutations in any of the 25 genes included in the bladder cancer assay kit"}

Primary endpoints

• {"endpoint_text":"- Proportion of patients with fatal event (death)","definition_or_measurement_approach":"Measured as the proportion of enrolled patients experiencing death during the study period."}
• {"endpoint_text":"- Proportion of patients with neobladder rejection","definition_or_measurement_approach":"Measured as the proportion of enrolled patients with documented neobladder rejection."}
• {"endpoint_text":"- Proportion of patients for whom revision surgery was required","definition_or_measurement_approach":"Measured as the proportion of enrolled patients requiring revision surgery."}
• {"endpoint_text":"- Proportion of patients who were free from the composite endpoint of death, neobladder rejection and need for revision surgery","definition_or_measurement_approach":"Measured as the proportion of enrolled patients without any of the composite events (death, neobladder rejection, revision surgery)."}
• {"endpoint_text":"- Peri-and post-surgical complications/SAEs","definition_or_measurement_approach":"Measured as incidence and proportion of participants experiencing peri- and post-surgical complications and serious adverse events (SAEs)."}

Secondary endpoints

• {"endpoint_text":"- 1.1 Device success, defined as successful delivery of the ATMP onto the neobladder according to the study protocol","definition_or_measurement_approach":"Defined explicitly in the endpoint: successful delivery of the ATMP onto the neobladder according to the study protocol."}
• {"endpoint_text":"- 1.2 Device adverse effects and deficiencies","definition_or_measurement_approach":"Measured as occurrence of device-related adverse effects and deficiencies."}
• {"endpoint_text":"- 1.3 Ease of use of the bioprinter","definition_or_measurement_approach":"Assessed as ease of use metrics for the bioprinter (not further defined in available data)."}
• {"endpoint_text":"- 2.1 Urinary continence","definition_or_measurement_approach":"Measured as assessment of urinary continence status post-reconstruction (method not detailed in available data)."}
• {"endpoint_text":"- 2.2 Absence of mucus","definition_or_measurement_approach":"Measured as absence/presence of mucus in neobladder (measurement approach not detailed)."}
• {"endpoint_text":"- 2.3 Metabolic imbalances and blood acidosis (blood)","definition_or_measurement_approach":"Measured via blood tests for metabolic imbalances and acidosis (specific biomarkers not detailed)."}
• {"endpoint_text":"- 2.4 Extent of coverage of the denuded intestinal tissue","definition_or_measurement_approach":"Measured as extent of ATMP coverage of denuded intestinal tissue (method not specified)."}
• {"endpoint_text":"- 2.5 Histological profile of regenerated urothelium","definition_or_measurement_approach":"Assessed by histological examination of regenerated urothelium."}
• {"endpoint_text":"- 2.6 Change from baseline in total score and in each specific domain of the Health-related quality of life (HRQoL) questionnaire EORTC QLQ-C30","definition_or_measurement_approach":"Measured as change from baseline in total and domain scores of EORTC QLQ-C30 questionnaire."}

Greece

Earliest CTIS Part Ii Submission Date

11-11-2025

Latest Decision Or Authorization Date

09-04-2026

Processing Time Days

149

Number Of Sites

2

Number Of Participants

6

Primary sponsor

Full Name

Phosprint P.C.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Greece

Contract research organisations

Name

Pharmassist Ltd.

Responsibilities

1,12,5,8

Third parties

• {"country":"Greece","full_name":"Genotypos Private Diagnostic Laboratory Of Molecular And Cytogenetic Analysis S.A.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Greece","full_name":"Pharmassist Ltd.","duties_or_roles":"1,12,5,8","organisation_type":"Pharmaceutical company"}