Condition or disease | Intervention/treatment | Phase |
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Advanced Hepatocellular Carcinoma | Drug: CAR-GPC3 T Cells | Phase 1 |
This is a phase I open-label, single and multiple infusion, dose escalation/cohort expansion study to evaluate the safety, cell pharmacokinetics, and preliminary efficacy of CAR-GPC3 T cells, infused intravenously in subjects who have been diagnosed with GPC3 positive advanced hepatocellular carcinoma and refractory or intolerant to current standard systemic treatment.
Primary objectives:
•To evaluate the safety and tolerability of CAR-GPC3 T cells infused intravenously at escalating doses in patients with advanced hepatocellular carcinoma.
Secondary objectives:
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Clinical Study of 4th Generation Chimeric Antigen Receptor T Cells Targeting Glypican-3 ( CAR-GPC3 T Cells) in Patients With Advanced Hepatocellular Carcinoma |
Actual Study Start Date : | July 23, 2019 |
Estimated Primary Completion Date : | June 30, 2021 |
Estimated Study Completion Date : | June 30, 2022 |
Arm | Intervention/treatment |
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Experimental: CAR-GPC3 T Cells
The subjects enrolled will be sequentially assigned to Part 1 at 3 dose levels via typical 3+3 dose escalation method and then Part 2, cohort expansion stage, 3 cohorts of CAR T therapy combination with currently available treatment for HCC. stage Part 1: Dose escalating: 3 dose level Part 2: 3 cohorts Cohort 1. Combination with tyrosine kinase inhibitors Cohort 2. Combination with PD-1 / PD-L1 monoclonal antibody Cohort 3. Combination with the drugs may benefit for patient at investigator's discretion
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Drug: CAR-GPC3 T Cells
Pretreatment with fludarabine and cyclophosphamide CAR-GPC3 T Cells infusion
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Adverse events occurring through18 weeks and 52weeks post infusion, such as abnormalities or changes in laboratory examinations, physical examinations, vital signs, etc.
Adverse events occurring through18 weeks and 52weeks post infusion, such as abnormalities or changes in laboratory examinations, physical examinations, vital signs, etc.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Weijia Fang | +86 15088681610 | weijiafang@zju.edu.cn | |
Contact: Qihan Fu | +86 15088681610 |
China, Zhejiang | |
First affiliated hospital, Zhejiang University | Recruiting |
Hangzhou, Zhejiang, China, 310006 | |
Contact: Weijia fang, MD | |
Principal Investigator: Tingbo Liang, MD |
Principal Investigator: | Tingbo Liang | The First Affiliated Hospital, Zhejiang University |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 2, 2019 | ||||||||
First Posted Date ICMJE | June 10, 2019 | ||||||||
Last Update Posted Date | October 15, 2019 | ||||||||
Actual Study Start Date ICMJE | July 23, 2019 | ||||||||
Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Dose limited toxicity and Maximum Tolerated Dose [ Time Frame: After 28 days of single infusion ] Safety and tolerability
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | 4th Generation Chimeric Antigen Receptor T Cells Targeting Glypican-3 | ||||||||
Official Title ICMJE | A Phase I Clinical Study of 4th Generation Chimeric Antigen Receptor T Cells Targeting Glypican-3 ( CAR-GPC3 T Cells) in Patients With Advanced Hepatocellular Carcinoma | ||||||||
Brief Summary | A Phase I Clinical Study of 4th generation Chimeric Antigen Receptor T Cells Targeting Glypican-3 ( CAR-GPC3 T Cells) in Patients with Advanced Hepatocellular Carcinoma | ||||||||
Detailed Description |
This is a phase I open-label, single and multiple infusion, dose escalation/cohort expansion study to evaluate the safety, cell pharmacokinetics, and preliminary efficacy of CAR-GPC3 T cells, infused intravenously in subjects who have been diagnosed with GPC3 positive advanced hepatocellular carcinoma and refractory or intolerant to current standard systemic treatment. Primary objectives: •To evaluate the safety and tolerability of CAR-GPC3 T cells infused intravenously at escalating doses in patients with advanced hepatocellular carcinoma. Secondary objectives:
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Hepatocellular Carcinoma | ||||||||
Intervention ICMJE | Drug: CAR-GPC3 T Cells
Pretreatment with fludarabine and cyclophosphamide CAR-GPC3 T Cells infusion
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||||||||
Study Arms ICMJE | Experimental: CAR-GPC3 T Cells
The subjects enrolled will be sequentially assigned to Part 1 at 3 dose levels via typical 3+3 dose escalation method and then Part 2, cohort expansion stage, 3 cohorts of CAR T therapy combination with currently available treatment for HCC. stage Part 1: Dose escalating: 3 dose level Part 2: 3 cohorts Cohort 1. Combination with tyrosine kinase inhibitors Cohort 2. Combination with PD-1 / PD-L1 monoclonal antibody Cohort 3. Combination with the drugs may benefit for patient at investigator's discretion
Intervention: Drug: CAR-GPC3 T Cells
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
36 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 30, 2022 | ||||||||
Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03980288 | ||||||||
Other Study ID Numbers ICMJE | CISLD-4 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | TingBo Liang, Zhejiang University | ||||||||
Study Sponsor ICMJE | Zhejiang University | ||||||||
Collaborators ICMJE | Carsgen Therapeutics, Ltd. | ||||||||
Investigators ICMJE |
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PRS Account | Zhejiang University | ||||||||
Verification Date | October 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |