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NCT03132922 · ClinicalTrials.gov registry record · Phase 1
MAGE-A4ᶜ¹º³²T for Multi-Tumor
A Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, sponsored by Adaptimmune.
- Active
- Registry status
- Phase 1
- Development phase
- 71
- Enrollment target
- 11
- Study locations
NCT03132922: Active Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, sponsored by Adaptimmune.
NCT03132922 is a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer that is active but no longer recruiting, run by Adaptimmune. The registered enrollment target is 71 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (89% lower). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03132922, a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, is active but no longer recruiting, sponsored by Adaptimmune.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 71 participants
- Enrollment target
- 11
- Study locations
Study 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.
Primary Outcome
An AE was defined as any untoward medical occurrence in a clinical study participant who received a pharmaceutical product, regardless of causality. An AE was , therefore, any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with AEs (including SAEs) are presented.
Conditions Studied
Interventions
- GENETIC Autologous genetically modified MAGE-A4ᶜ¹º³²T cells
- RADIATION Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation
Study Locations (11)
Florida
- University of Miami - Miami
- Moffitt Cancer Center - Tampa
Missouri
- Washington University School of Medicine - St Louis
- Washington University - St Louis
New York
- Roswell Park Cancer Institute - Buffalo
North Carolina
- Duke University Medical Center, Duke Cancer Institute - Durham
Ohio
- Ohio State University Wexner Medical Center - Columbus
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Tennessee
- Tennessee Oncology - Sarah Cannon Research Institute - Nashville
Texas
- M.D. Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2017-05-15 |
| Est. Completion | 2032-09 |
| Phase | Phase 1 |
What the registry record for NCT03132922 still lists
NCT03132922 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (89% lower).
The record links to 10 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Autologous genetically modified MAGE-A4ᶜ¹º³²T cells is the first listed.
NCT03132922 lists 11 locations in 9 states (Florida, Missouri, New York).
Frequently Asked Questions
What is clinical trial NCT03132922 about?
NCT03132922 is a clinical study titled "MAGE-A4ᶜ¹º³²T for Multi-Tumor". 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 (M...
What is the current status of trial NCT03132922?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2017-05-15. Estimated completion is 2032-09.
What conditions does trial NCT03132922 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Ovarian Cancer, Melanoma, Head and Neck Cancer, Gastric Cancer.
What interventions are being tested in trial NCT03132922?
The interventions under investigation include: Autologous genetically modified MAGE-A4ᶜ¹º³²T cells (GENETIC), Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation (RADIATION).
Who is sponsoring clinical trial NCT03132922?
This trial is sponsored by Adaptimmune, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03132922 being conducted?
This trial has 11 study locations across Florida, Missouri, New York, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03132922's enrollment target sits among peer trials
71 286th of 454 higher than 167 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
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