Recruiting NCT03185468
Intervention of Bladder Cancer by CAR-T
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 4SCAR-PSMA, 4SCAR-FRa.
- Who it may be relevant to
- Registry conditions: Bladder Cancer, Urothelial Carcinoma Bladder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intervention of Advanced or Metastatic Urothelial Bladder Cancer by 4SCAR-T Cell Therapies
Overview
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.
Interventions
- Genetic 4SCAR-PSMA
PSMA-specific 4th Generation CART - Genetic 4SCAR-FRa
FRa-specific 4th Generation CART
Primary outcome measures
- Overall Survival rate after receiving 4SCART infusion [Time frame: 1 year]
- Using CTCAE 4 standard to evaluate the level of adverse events after receiving 4SCART infusion [Time frame: 3 months]
Secondary outcome measures (2)
- The expansion and persistence of 4SCAR T cells [Time frame: 1 year]
- Immune responses after infusions [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra)
- Representative tumor specimens as specified by the protocol
- Adequate hematologic and end organ function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than or equal to (>/=) 12 weeks
- Measurable disease, as defined by RECIST v1.1
Exclusion criteria
- Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
- 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
- Leptomeningeal disease
- Malignancies other than UBC within 5 years prior to Cycle 1, Day 1
- Pregnant and lactating women
- Significant cardiovascular disease
- Severe infections within 4 weeks prior to infusion
- Major surgical procedure other than for diagnosis within 4 weeks
- 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
- History of autoimmune disease
- Prior allogeneic stem cell or solid organ transplant
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
- Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shenzhen Geno-immune Medical Institute — Shenzhen
Identifiers
NCT: NCT03185468 · GIMI-IRB-17004