CAR-T treatment for advanced urothelial (bladder) cancer

Intervention of Advanced or Metastatic Urothelial Bladder Cancer by 4SCAR-T Cell Therapies

Try 4SCAR-T cell therapy in people with locally advanced or metastatic urothelial bladder cancer who have no standard treatment options left.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shenzhen Geno-Immune Medical Institute (Academic / other)
• Drugs / interventions: atezolizumab
• Locations: 2 sites (Shenzhen, Gongdong and 1 other locations)
• Trial ID: NCT03185468 on ClinicalTrials.gov

What this trial studies

This multicenter Phase I/II trial tests 4SCAR-T cells (4SCAR-PSMA and 4SCAR-FRa) in participants with locally advanced or metastatic urothelial bladder cancer who have exhausted standard therapies. Eligible patients must have histologically confirmed disease, measurable tumors by RECIST v1.1, ECOG 0–1, and adequate organ function. Participants will receive the CAR-T product and undergo close monitoring for safety, adverse events, and anti-tumor responses over scheduled follow-up visits. The trial is designed to characterize both the tolerability and preliminary anti-cancer activity of the 4SCAR-T approaches in this population.

Who should consider this trial

Good fit: Adults with histologically or cytologically confirmed locally advanced or metastatic urothelial carcinoma (including renal pelvis, ureters, bladder, or urethra), measurable disease, ECOG performance status 0–1, adequate organ function, and available tumor specimens are eligible.

Not a fit: Patients with active or untreated CNS metastases or leptomeningeal disease, recent other anti-cancer therapy or investigational treatment, other malignancies within five years, or poor performance status are unlikely to qualify or benefit from this trial.

Why it matters

Potential benefit: If successful, the therapy could shrink tumors or produce durable responses in patients who have no other standard treatment options.

How similar studies have performed: CAR-T therapies have achieved major success in blood cancers but have shown limited and inconsistent results in solid tumors to date, so this approach remains largely experimental for bladder cancer.

Eligibility criteria

Inclusion Criteria:

1. Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra)
2. Representative tumor specimens as specified by the protocol
3. Adequate hematologic and end organ function
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Life expectancy greater than or equal to (\>/=) 12 weeks
6. Measurable disease, as defined by RECIST v1.1

Exclusion Criteria:

1. Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
2. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
3. Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
4. Leptomeningeal disease
5. Malignancies other than UBC within 5 years prior to Cycle 1, Day 1
6. Pregnant and lactating women
7. Significant cardiovascular disease
8. Severe infections within 4 weeks prior to infusion
9. Major surgical procedure other than for diagnosis within 4 weeks
10. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
11. History of autoimmune disease
12. Prior allogeneic stem cell or solid organ transplant
13. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
14. Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis

Where this trial is running

Shenzhen, Gongdong and 1 other locations

• Shenzhen Second People Hospital — Shenzhen, Gongdong, China (Recruiting)
• Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Lung-Ji Chang, PhD — Shenzhen Geno-Immune Medical Institute
• Study coordinator: Lung-Ji Chang, PhD

Conditions Bladder Cancer; Urothelial Carcinoma Bladder; CAR T; Bladder