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Surpass: ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04044859
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Adaptimmune

Brief Summary:
This study will investigate the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumor antigen status and whose synovial sarcoma, myxoid/round cell liposarcoma (MRCLS), melanoma, urothelial, head and neck, ovarian, gastric (stomach), esophagogastric junction (EGJ), non-small cell lung (NSCLC), or esophageal cancer that express the MAGE-A4 protein.

Condition or disease Intervention/treatment Phase
Synovial Sarcoma Myxoid/Round Cell Liposarcoma (MRCLS) Melanoma Urothelial Carcinoma Head and Neck Ovarian Gastric Cancer Esophagogastric Junction Disorder Nonsmall Cell Lung Cancer Esophageal Cancer Genetic: Autologous genetically modified ADP-A2M4CD8 cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation Study To Assess Safety And Efficacy Of ADP-A2M4CD8 In HLA-A2+ Subjects With MAGE-A4 Positive Tumors
Actual Study Start Date : July 10, 2019
Estimated Primary Completion Date : January 14, 2021
Estimated Study Completion Date : January 14, 2021


Arm Intervention/treatment
Experimental: Autologous genetically modified ADP-A2M4CD8 cells Genetic: Autologous genetically modified ADP-A2M4CD8 cells
Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1




Primary Outcome Measures :
  1. Number of subjects with treatment -related adverse events (AEs), including serious adverse events (SAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: 2.5 years ]
    Determine if treatment with ADP-A2M4CD8 is safe and tolerable through assessment of adverse events (AEs) including Serious Adverse Events (SAEs)

  2. Evaluate safety of ADP-A2M4CD8 through measurement of Replication -competent Retrovirus in genetically engineered T-cells [ Time Frame: 15 years ]
    Evaluation of RCL using PCR -based assay in peripheral blood.


Secondary Outcome Measures :
  1. Anti-tumour activity: Overall Response Rate (ORR) [ Time Frame: 2.5 years ]
    ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1

  2. Anti-tumor activity: Best overall response (BOR) [ Time Frame: 2.5 years ]
    BOR is per RECIST V1.1.

  3. Time to response (TTR) [ Time Frame: 2.5 years ]
    For patients who are observed to respond to ADP-A2M4CD8, the time taken from date of infusion to achieve a partial response or complete response (TTR) is assessed

  4. Duration of Response (DOR) [ Time Frame: 2.5 years ]
    For patients who are observed to respond to ADP-A2M4CD8, the DOR is the date of initial response (including confirmation) from date of infusion up until disease progression per RECIST v 1.1 or death.

  5. Duration of stable disease (DoSD) [ Time Frame: 2.5 years ]
    For patients who are observed to have stable disease by RECIST v 1.1, the duration of period of stable disease until disease progression or death

  6. Progression Free Survival (PFS) [ Time Frame: 2.5 years ]
    PFS is assessed from date of infusion of ADP-A2M4CD8 up until the date of disease progression per RECIST v1.1 or death.

  7. Overall Survival (OS) [ Time Frame: 15 years ]
    OS is assessed from date of infusion of ADP-A2M4CD8 up until the date of patient death.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Key Inclusion criteria
  • Age ≥18 and ≤ 75 years
  • Histologically or cytogenetically confirmed diagnosis of urothelial cancer, melanoma, ovarian cancer, esophageal , esophagogastric junction (EGJ) cancer, gastric cancer, non-small cell lung carcinoma (NSCLC), head and neck, synovial sarcoma or myxoid/round cell liposarcoma (MRCLS)
  • Measurable disease according to RECIST v1.1 prior to leukapheresis and lymphodepletionHLA-A*02 positive.
  • Tumor shows MAGE-A4 expression as confirmed by central laboratory
  • ECOG Performance Status of 0 or 1.
  • Left ventricular ejection fraction (LVEF) ≥50% or the institutional lower limit of normal range, whichever is lower Note: other protocol defined Inclusion/Exclusion criteria may apply

Key exclusion criteria

  • Positive for HLA-A*02:05 or HLA-A*02 allele other than A*02:07 or A*02 null allele
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study
  • History of autoimmune or immune mediated disease
  • Leptomeningeal disease, carcinomatous meningitis or symptomatic CNS metastases
  • Other prior malignancy that is not considered by the Investigator to be in complete remission. Clinically significant cardiovascular disease
  • Uncontrolled intercurrent illness
  • Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
  • Pregnant or breastfeeding

Note: other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044859


Locations
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United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Donald Lawrence, MD         
United States, Missouri
Washington University - School of Medicine Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Nic Perry    314-362-6470    nperry@wustl.edu   
Principal Investigator: Tanner M Johanna, MD         
United States, New York
Roswell Park Cancer Institute Not yet recruiting
Buffalo, New York, United States, 14040
Contact: Heather Cameron    716-845-1780    Heather.Cameron@RoswellPark.org   
Principal Investigator: Adekunle O Odunsi, MD, PhD         
United States, North Carolina
Duke University Medical Center, Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Contact: Patricia Borgia    919-684-8142    patricia.borgia@duke.edu   
Principal Investigator: Jeffrey M Clarke, MD         
United States, Oklahoma
University of Oklahoma Health Sciences Center Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Cynthia Lowery    405-271-8777    Cynthia-Lowery@ouhsc.edu   
Principal Investigator: Adam Asch         
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Allison Scott       Allison.Scott@jefferson.edu   
Principal Investigator: Matthew Carabasi, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Matthew Walker    615-329-7304    Matthew.Walker@SarahCannon.com   
Contact: Chris Earwood       Chris.Earwood@sarahcannon.com   
Principal Investigator: Melissa Johnson, MD         
United States, Texas
M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Danxia Ke    713-792-4384    DKe@mdanderson.org   
Principal Investigator: David Hong, MD         
United States, Wisconsin
Medical College of Wisconsin Froedtert Hospital Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Kaylee Meisinger       kmeisinger@mcw.edu   
Principal Investigator: John A Charlson, MD         
Belgium
Cliniques Universitaires Saint-Luc Not yet recruiting
Bruxelles, Belgium
Principal Investigator: Jean-Pascal Machiels         
University Hospital Antwerp Not yet recruiting
Edegem, Belgium
Principal Investigator: Has Prenen         
Universitair Ziekenhuis Gent Not yet recruiting
Gent, Belgium
Principal Investigator: Sylvie Rottey, MD         
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Sawako Elston    4169462945    Sawako.Elston@uhn.ca   
Principal Investigator: Marcus Butler, MD         
Spain
Hospital 12 De Octubre Not yet recruiting
Madrid, Avenida De Cordoba S/n, Spain, 28041
Contact: Marta Gutierrez       unidadfase1.imas12@h12o.es   
Principal Investigator: Jose Lopez-Martin, MD         
Start Madrid-FJD, Fundación Jimѐnez Díaz Not yet recruiting
Madrid, Spain, 28040
Contact: Adriana Armellini       adriana.armellini@startmadrid.com   
Principal Investigator: Victor Moreno, MD         
Start Madrid-HM COICC Early Phase Program Not yet recruiting
Madrid, Spain
Contact: Dalmazio Danini    620423957    dalmazio.danini@startmadrid.com   
Principal Investigator: Emiliano Calvo, MD         
Sponsors and Collaborators
Adaptimmune

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Responsible Party: Adaptimmune
ClinicalTrials.gov Identifier: NCT04044859    
Other Study ID Numbers: ADP-0055-001
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adaptimmune:
Immuno-oncology
Esophageal Cancer
Cell Therapy
T Cell Therapy
SPEAR T Cell
MAGE-A4
Metastatic
Synovial Sarcoma
Myxoid/Round Cell Liposarcoma (MRCLS)
Melanoma
Urothelial
Head and Neck
Ovarian
Gastric (stomach)
Esophagogastric Junction (EGJ)
Non-small Cell Lung (NSCLC)
Additional relevant MeSH terms:
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Esophageal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Neoplasms, Connective and Soft Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Neoplasms, Adipose Tissue
Neoplasms, Connective Tissue
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Melanoma
Sarcoma
Liposarcoma
Sarcoma, Synovial
Carcinoma, Non-Small-Cell Lung
Liposarcoma, Myxoid
Nevi and Melanomas
Digestive System Diseases
Gastrointestinal Diseases
Esophageal Diseases
Carcinoma, Bronchogenic
Lung Diseases