CAR-T Cell Immunotherapy in MUC1 Positive Solid Tumor
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ClinicalTrials.gov Identifier: NCT02617134 |
Recruitment Status : Unknown
Verified July 2016 by PersonGen BioTherapeutics (Suzhou) Co., Ltd..
Recruitment status was: Recruiting
First Posted : November 30, 2015
Last Update Posted : December 6, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | November 26, 2015 | |||
First Posted Date ICMJE | November 30, 2015 | |||
Last Update Posted Date | December 6, 2016 | |||
Study Start Date ICMJE | November 2015 | |||
Estimated Primary Completion Date | November 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Adverse events attributed to the administration of the anti-MUC1 CAR-T cells [ Time Frame: 2 years ] Determine the toxicity profile of the MUC1 targeted CAR-T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Objective Response Rate [ Time Frame: Safety follow-up is 100 days from last CAR-T infusion. ] The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline.
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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 | CAR-T Cell Immunotherapy in MUC1 Positive Solid Tumor | |||
Official Title ICMJE | Immunotherapy With Chimeric Antigen Receptor-Modified T Cells for MUC1 Positive Advanced Refractory Solid Tumor | |||
Brief Summary | The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in patients with MUC1 positive relapsed or refractory solid tumor. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Biological: anti-MUC1 CAR-T cells
Other Name: anti-MUC1-CAR transduced autologous T cells
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Study Arms ICMJE | Experimental: CAR-T cell immunotherapy
Enrolled patients will receive CAR-T cell immunotherapy with a novel specific chimeric antigen receptor targeting MUC1 antigen by infusion.
Intervention: Biological: anti-MUC1 CAR-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 | Unknown status | |||
Estimated Enrollment ICMJE |
20 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | November 2018 | |||
Estimated Primary Completion Date | November 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: Male and female subjects with MUC1+ malignancies in patients with no available curative treatment options who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02617134 | |||
Other Study ID Numbers ICMJE | PG-021-002 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | PersonGen BioTherapeutics (Suzhou) Co., Ltd. | |||
Study Sponsor ICMJE | PersonGen BioTherapeutics (Suzhou) Co., Ltd. | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | PersonGen BioTherapeutics (Suzhou) Co., Ltd. | |||
Verification Date | July 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |