MAGE-A4ᶜ¹º³²T for Multi-Tumor
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ClinicalTrials.gov Identifier: NCT03132922 |
Recruitment Status :
Active, not recruiting
First Posted : April 28, 2017
Last Update Posted : October 5, 2021
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Sponsor:
Adaptimmune
Information provided by (Responsible Party):
Adaptimmune
Tracking Information | |||||
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First Submitted Date ICMJE | April 25, 2017 | ||||
First Posted Date ICMJE | April 28, 2017 | ||||
Last Update Posted Date | October 5, 2021 | ||||
Actual Study Start Date ICMJE | July 5, 2017 | ||||
Estimated Primary Completion Date | September 2032 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
MAGE-A4c1032T cell trafficking in tumor lesion(s). [ Time Frame: 3.5 years ] Evaluation of post-infusion T-cell trafficking in irradiated vs non-irradiation lesions
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||
Brief Title ICMJE | MAGE-A4ᶜ¹º³²T for Multi-Tumor | ||||
Official Title ICMJE | Phase 1 Dose Escalation, Multi-tumor Study to Assess the Safety, Tolerability and Antitumor Activity of Genetically Engineered MAGE-A4ᶜ¹º³²T in HLA-A2+ Subjects With MAGE-A4 Positive Tumors | ||||
Brief Summary | This study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in subjects who have the appropriate HLA-A2 tissue marker and whose urinary bladder, melanoma, head and neck, ovarian, non-small cell lung, esophageal, gastric, synovial sarcoma, or myxoid/round call liposarcoma (MRCLS) tumor has the MAGE-A4 protein expressed. This study will take a subject's T cells and give them a T cell receptor protein that recognizes and attacks the tumors. This study has a substudy component that will investigate the safety and tolerability of MAGE-A4c1032T cell therapy in combination with low dose radiation in up to 10 subjects. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
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 |
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Study Arms ICMJE |
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Publications * | Sanderson JP, Crowley DJ, Wiedermann GE, Quinn LL, Crossland KL, Tunbridge HM, Cornforth TV, Barnes CS, Ahmed T, Howe K, Saini M, Abbott RJ, Anderson VE, Tavano B, Maroto M, Gerry AB. Preclinical evaluation of an affinity-enhanced MAGE-A4-specific T-cell receptor for adoptive T-cell therapy. Oncoimmunology. 2019 Nov 24;9(1):1682381. doi: 10.1080/2162402X.2019.1682381. eCollection 2020. | ||||
* 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 | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
52 | ||||
Original Estimated Enrollment ICMJE |
32 | ||||
Estimated Study Completion Date ICMJE | September 2035 | ||||
Estimated Primary Completion Date | September 2032 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
7. Subject has anticipated life expectancy > 6 months prior to leukapheresis and >3 months prior to lymphodepletion. Exclusion Criteria:
Additional Exclusion Criteria for the Radiation Substudy:
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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 | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03132922 | ||||
Other Study ID Numbers ICMJE | ADP-0044-001 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Adaptimmune | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Adaptimmune | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Adaptimmune | ||||
Verification Date | October 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |