Intervention of Bladder Cancer by CAR-T

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03185468
• Other study ID #: GIMI-IRB-17004
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 15, 2017
• Est. completion date: December 2020

Study information

• Verified date: September 2019
• Source: Shenzhen Geno-Immune Medical Institute
• Contact: Lung-Ji Chang, PhD
• Phone: 86-13671121909
• Email: c[@]szgimi.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase I/II and multicenter study designed to evaluate the efficacy and safety of 4SCAR-T cells in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have no further treatment available.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms
• Urothelial Carcinoma Bladder

Intervention

Genetic:
• 4SCAR-PSMA
PSMA-specific 4th Generation CART
• 4SCAR-FRa
FRa-specific 4th Generation CART

Locations

Country	Name	City	State
China	Shenzhen Geno-immune Medical Institute	Shenzhen	Guangdong
China	Shenzhen Second People Hospital	Shenzhen	Gongdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Geno-Immune Medical Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival rate after receiving 4SCART infusion	to determine the efficacy of 4SCAR T cells	1 year
Primary	Using CTCAE 4 standard to evaluate the level of adverse events after receiving 4SCART infusion	to evaluate the level of adverse events with CTCAE 4	3 months
Secondary	The expansion and persistence of 4SCAR T cells	The investigators will monitor the expansion and functional persistence of 4SCAR T cells in the peripheral blood of patients and the correlation with antitumor effects	1 year
Secondary	Immune responses after infusions	assessment of cytokine profile	3 months