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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 : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Adaptimmune

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
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 : April 30, 2018
Estimated Primary Completion Date : January 14, 2021
Estimated Study Completion Date : January 14, 2036

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arms and Interventions
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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


Outcome Measures
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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.


Eligibility Criteria
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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
  • Subject is positive for at least 1 HLA-A*02 inclusion allele
  • 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 any HLA-A*02 allele other than: one of the inclusion alleles
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study
  • Active 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.

Contacts and Locations
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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


Contacts
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Contact: David Hong, MD 713-563-5844 dshong@madanderson.org

Locations
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Sponsors and Collaborators
Adaptimmune
Investigators
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Principal Investigator: David Hong, MD M.D. Anderson Cancer Center
More Information
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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: October 22, 2020
Last Verified: October 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:
Cell Therapy
T Cell Therapy
SPEAR T Cell
MAGE-A4
Immuno-oncology
Metastatic
Synovial Sarcoma
Myxoid/Round Cell Liposarcoma (MRCLS)
 Melanoma
Urothelial
Head and Neck
Ovarian
Gastric (stomach)
Esophagogastric Junction (EGJ)
Non-small Cell Lung (NSCLC)
Esophageal Cancer
Additional relevant MeSH terms:
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Melanoma
Sarcoma
Esophageal Neoplasms
Liposarcoma
Sarcoma, Synovial
Carcinoma, Non-Small-Cell Lung
Liposarcoma, Myxoid
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Connective and Soft Tissue
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Head and Neck Neoplasms
Esophageal Diseases
Neoplasms, Adipose Tissue
Neoplasms, Connective Tissue
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases