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Clinical Trial Finder

Search Results

MAGE-A4ᶜ¹º³²T for Multi-Tumor

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subject is ≥18 to 75 years of age at the time of signing the study informed consent. 2. Subject has histologically confirmed diagnosis of any one of the indicated tumor types. 3. Subject is HLA-A*02 positive. (This determination will be made under screening protocol ADP-0000-001). 4. Subject's tumor shows expression of the MAGE-A4 RNA or protein. (This determination will be made under screening protocol ADP-0000-001). 5. Adequate organ function as indicated in the study protocol. 6. Subject has measurable disease according to RECIST v1.1 criteria prior to lymphodepletion. 7. Subject meets disease-specific requirements per protocol. 7. Subject has anticipated life expectancy > 6 months prior to leukapheresis and >3 months prior to lymphodepletion.

Exclusion Criteria:

1. Subject does not express appropriate HLA-A genotype. 2. Subject is receiving excluded therapy/treatment per protocol. 3. Subject has symptomatic CNS metastases. 4. Subject has any other active malignancy besides the tumor under study within 3 years prior to Screening. Subject has uncontrolled intercurrent illness. 5. Subject has active infection with HIV, HBV, HCV or HTLV. 6. Subject is pregnant or breastfeeding. Additional Exclusion Criteria for the Radiation Substudy:
  • - Subject does not meet eligibility criteria for the main study (ADP-0044-001).
  • - Subject does not have at least one target lesion amenable to radiation.
  • - Certain radiation therapy within 6 months of clinical trial are an exclusion.
  • - Metastatic disease impinging on the spinal cord or threatening spinal cord compression.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03132922
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Adaptimmune
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David Hong, MD
Principal Investigator Affiliation M.D. Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Urinary Bladder Cancer, Melanoma, Head and Neck Cancer, Ovarian Cancer, Non-Small Cell Lung Cancer, Esophageal Cancer, Gastric Cancer, Synovial Sarcoma, Myxoid Round Cell Liposarcoma, Gastroesophageal Junction
Arms & Interventions

Arms

Experimental: Autologous genetically modified MAGE-A4ᶜ¹º³²T cells

Experimental: Radiation Sub-Study: Autologous genetically modified MAGE-A4c1

Interventions

Genetic: - Autologous genetically modified MAGE-A4ᶜ¹º³²T cells

Infusion of autologous genetically modified MAGE-A4ᶜ¹º³²T on Day 1

Radiation: - Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation

Up to 10 subjects will be considered for Radiation sub-study. Radiation with an intensity of 1.4Gy for 5 days before infusion of MAGE-A4c1032T cells

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Miami, Miami, Florida

Status

Address

University of Miami

Miami, Florida, 33136

Moffitt Cancer Center, Tampa, Florida

Status

Address

Moffitt Cancer Center

Tampa, Florida, 33612

Washington University School of Medicine, Saint Louis, Missouri

Status

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Washington University, Saint Louis, Missouri

Status

Address

Washington University

Saint Louis, Missouri, 63112

Roswell Park Cancer Institute, Buffalo, New York

Status

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263

Durham, North Carolina

Status

Address

Duke University Medical Center, Duke Cancer Institute

Durham, North Carolina, 27710

Columbus, Ohio

Status

Address

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

Fox Chase Cancer Center, Philadelphia, Pennsylvania

Status

Address

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

Nashville, Tennessee

Status

Address

Tennessee Oncology - Sarah Cannon Research Institute

Nashville, Tennessee, 37203

M.D. Anderson Cancer Center, Houston, Texas

Status

Address

M.D. Anderson Cancer Center

Houston, Texas, 77030

International Sites

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Status

Address

Princess Margaret Cancer Centre

Toronto, Ontario, M5G1X6

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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