Clinical trial NCT03185468: Intervention of Bladder Cancer by CAR-T
Official title: Intervention of Advanced or Metastatic Urothelial Bladder Cancer by 4SCAR-T Cell Therapies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Bladder Cancer
Urothelial Carcinoma Bladder
Keywords: CAR T
Bladder
Lead sponsor: Shenzhen Geno-Immune Medical Institute
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall Survival rate after receiving 4SCART infusion
timeFrame: 1 year
measure: Using CTCAE 4 standard to evaluate the level of adverse events after receiving 4SCART infusion
timeFrame: 3 months
Secondary outcomes:
measure: The expansion and persistence of 4SCAR T cells
timeFrame: 1 year
measure: Immune responses after infusions
timeFrame: 3 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second People Hospital
state: Gongdong
city: Shenzhen
country: China
facility: Shenzhen Geno-immune Medical Institute
state: Guangdong
Study officials:
affiliation: Shenzhen Geno-Immune Medical Institute
name: Lung-Ji Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References: