Intervention of Bladder Cancer by CAR-T

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

Tracking Information

• First Submitted Date: June 10, 2017
• First Posted Date: June 14, 2017
• Last Update Posted Date: September 19, 2019
• Actual Study Start Date: May 15, 2017
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 10, 2017)

• Overall Survival rate after receiving 4SCART infusion [ Time Frame: 1 year ]
  to determine the efficacy of 4SCAR T cells
• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 10, 2017)

• 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
• Immune responses after infusions [ Time Frame: 3 months ]
  assessment of cytokine profile

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Intervention of Bladder Cancer by CAR-T
• Official Title: Intervention of Advanced or Metastatic Urothelial Bladder Cancer by 4SCAR-T Cell Therapies
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Bladder Cancer
• Urothelial Carcinoma Bladder

Intervention

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

Study Arms

• 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.
  Intervention: Genetic: 4SCAR-PSMA
• 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.
  Intervention: Genetic: 4SCAR-FRa

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 10, 2017): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03185468
• Other Study ID Numbers: GIMI-IRB-17004
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Shenzhen Geno-Immune Medical Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Shenzhen Geno-Immune Medical Institute
• Verification Date: September 2019