Intervention of Bladder Cancer by CAR-T

• Sponsor: Shenzhen Geno-Immune Medical Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03185468
• Collaborator: (none)
• Enrollment: 20
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 42.6
• Patients Per Site: 10
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer; Urothelial Carcinoma Bladder	Genetic: 4SCAR-PSMA; Genetic: 4SCAR-FRa	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intervention of Advanced or Metastatic Urothelial Bladder Cancer by 4SCAR-T Cell Therapies
• Actual Study Start Date: May 15, 2017
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 4SCAR-PSMA 4SCAR PSMA-modified T cells can recognize and kill tumor cells through the recognize of PSMA .This study will evaluate the side effects and effective doses of 4SCAR-PSMA T cells in treating refractory and recurrent solid tumors.	Genetic: 4SCAR-PSMA; PSMA-specific 4th Generation CART
Experimental: 4SCAR-FRa 4SCAR FRa-modified T cells can recognize and kill tumor cells through the recognize of FRa .This study will evaluate the side effects and effective doses of 4SCAR-FRa T cells in treating refractory and recurrent solid tumors.	Genetic: 4SCAR-FRa; FRa-specific 4th Generation CART

Outcome Measures

Primary Outcome Measures

1. Overall Survival rate after receiving 4SCART infusion [1 year]

   to determine the efficacy of 4SCAR T cells

2. Using CTCAE 4 standard to evaluate the level of adverse events after receiving 4SCART infusion [3 months]

   to evaluate the level of adverse events with CTCAE 4

Secondary Outcome Measures

1. The expansion and persistence of 4SCAR T cells [1 year]

   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

2. Immune responses after infusions [3 months]

   assessment of cytokine profile

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shenzhen Second People Hospital	Shenzhen	Gongdong	China
2	Shenzhen Geno-immune Medical Institute	Shenzhen	Guangdong	China	518000

Sponsors and Collaborators

• Shenzhen Geno-Immune Medical Institute

Investigators

• Principal Investigator: Lung-Ji Chang, PhD, Shenzhen Geno-Immune Medical Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lung-Ji Chang, President, Shenzhen Geno-Immune Medical Institute
• ClinicalTrials.gov Identifier: NCT03185468
• Other Study ID Numbers: GIMI-IRB-17004
• First Posted: Jun 14, 2017
• Last Update Posted: Sep 19, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lung-Ji Chang, President, Shenzhen Geno-Immune Medical Institute: CAR T; Bladder
• Additional relevant MeSH terms: Urinary Bladder Neoplasms

Study Results

No Results Posted as of Sep 19, 2019