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Intervention of Bladder Cancer by CAR-T

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ClinicalTrials.gov Identifier: NCT03185468
Recruitment Status : Unknown
Verified September 2019 by Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute.
Recruitment status was:  Recruiting
First Posted : June 14, 2017
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Overall Survival rate after receiving 4SCART infusion [ Time Frame: 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 [ Time Frame: 3 months ]
    to evaluate the level of adverse events with CTCAE 4


Secondary Outcome Measures :
  1. The expansion and persistence of 4SCAR T cells [ Time Frame: 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 [ Time Frame: 3 months ]
    assessment of cytokine profile


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185468


Contacts
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Contact: Lung-Ji Chang, PhD 86-13671121909 c@szgimi.org
Contact: Aifa Tang, PhD tangaifa2004@163.com

Locations
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China, Gongdong
Shenzhen Second People Hospital Recruiting
Shenzhen, Gongdong, China
Contact: AiFa Tang, Ph. D       tangaifa2004@163.com   
China, Guangdong
Shenzhen Geno-immune Medical Institute Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Lung-Ji Chang, PhD    86-13671121909    c@szgimi.org   
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
Investigators
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Principal Investigator: Lung-Ji Chang, PhD Shenzhen Geno-Immune Medical Institute
More Information
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Responsible Party: Lung-Ji Chang, President, Shenzhen Geno-Immune Medical Institute
ClinicalTrials.gov Identifier: NCT03185468    
Other Study ID Numbers: GIMI-IRB-17004
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute:
CAR T
Bladder
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases