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Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

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ClinicalTrials.gov Identifier: NCT04044768
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Adaptimmune

Brief Summary:
This is a study of genetically engineered ADP-A2M4 in HLA-A*02 subjects with metastatic or inoperable (advanced) Synovial Sarcoma or MRCLS who have received prior chemotherapy and whose tumor expresses the MAGE-A4 tumor antigen.

Condition or disease Intervention/treatment Phase
Synovial Sarcoma Myxoid Liposarcoma Genetic: ADP-A2M4 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR™ T Cells in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
Actual Study Start Date : July 24, 2019
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : November 1, 2034


Arm Intervention/treatment
Experimental: Autologous genetically modified ADP-A2M4 Genetic: ADP-A2M4
Autologous genetically modified ADP-A2M4 Dose: 1.0 x109 to 10x109 transduced by a single intravenous infusion




Primary Outcome Measures :
  1. Efficacy: 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


Secondary 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-A2M4 is safe and tolerable through assessment of adverse events (AEs) including Serious Adverse Events (SAEs

  2. Evaluate safety of ADP-A2M4 through measurement of Replication -competent Retrovirus in genetically engineered T-cells [ Time Frame: 2.5 years ]
    Evaluation of RCL using PCR -based assay in peripheral blood.

  3. Measurement of T-cell clonality and insertional oncogenesis in peripheral blood mononuclear cells (PBMCs). [ Time Frame: 2.5 years ]
    Measurement of T-cell clonality and insertional oncogenesis in peripheral blood mononuclear cells (PBMCs )

  4. Efficacy: Best overall response (BOR) [ Time Frame: 2.5 years ]
    BOR is per RECIST V1.1.

  5. Time to response (TTR) [ Time Frame: 2.5 years ]
    For patients who are observed to respond to ADP-A2M4, the time taken from date of infusion to achieve a partial response or complete response (TTR) is assessed.

  6. Duration of Response (DoR) [ Time Frame: 2.5 years ]
    For patients who are observed to respond to ADP-A2M4, 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.

  7. Progression Free Survival (PFS) [ Time Frame: 2.5 years ]
    PFS is assessed from date of infusion of ADP-A2M4 up until the date of disease progression per RECIST v1.1 or death.

  8. Overall Survival (OS) [ Time Frame: 15 years ]
    OS is assessed from date of infusion of ADP-A2M4 up until the date of patient death

  9. Quantitation of genetically engineered T-cells in PBMCs [ Time Frame: 2.5 years ]
    Quantitation of genetically engineered T-cells in PBMCs by qPCR

  10. Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs [ Time Frame: 2.5 years ]
    Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by flow cytometry

  11. Quantitation of genetically engineered T-cells in PBMCs [ Time Frame: 2.5 years ]
    Quantitation of genetically engineered T-cells in PBMCs by flow cytometry

  12. Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs [ Time Frame: 2.5 years ]
    Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by qPCR

  13. Invitro diagnostic (IVD) assay for screening [ Time Frame: 2.5 years ]
    Development and validation of the MAGE-A4 antigen expression companion diagnostic assay



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria

  • Age ≥16 and <75 years
  • Diagnosis of advanced synovial sarcoma or myxoid liposarcoma / myxoid round cell liposarcoma confirmed by cytogenetics.
  • Previously received either an anthracycline or ifosfamide containing regimen.
  • Measurable disease according to RECIST v1.1.
  • HLA-A*02 positive
  • Tumor shows MAGE-A4 expression confirmed by central laboratory.
  • ECOG Performance Status of 0 or1.
  • Left ventricular ejection fraction (LVEF) ≥40%.

Note: other protocol defined Inclusion criteria may apply

Key Exclusion Criteria:

  • HLA-A*02:05 in either allele; HLA-A*02:07 or any A*02 null allele as the sole HLA-A*02 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 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): NCT04044768


Contacts
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Contact: Deijka Aruajo, MD 713-792-3626 daraujo@mdanderson.org

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Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Natt Supab    626-218-0479    nsupab@coh.org   
Contact: Natt Supab         
Principal Investigator: Warren Chow, MD         
Stanford Cancer Center Not yet recruiting
Palo Alto, California, United States, 94305
Contact: Maria S Ahern    650-725-6413    mahern@stanfird.edu   
Principal Investigator: Kristen Ganjoo, MD         
United States, Colorado
University of Colorado Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Courtney Newbold    720-848-0653    coutney.newbold@ucdenver.edu   
Principal Investigator: Breelyn Wilky, MD         
United States, Florida
Mayo Clinic Jacksonville Not yet recruiting
Jacksonville, Florida, United States, 33612
Contact: Margo Althusis-Brown       Althuis-Brown.Margot@mayo.edu   
Principal Investigator: Steven Attia, MD         
Moffitt Cancer Center Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Matt Taddeo    817-745-1346    Matt.Taddeo@moffitt.org)   
Contact: Rachel Soto    813-745-4608    Rachel.Soto@moffitt.org   
Principal Investigator: Michaele Druta, MD         
United States, Illinois
Northwestern University Robert H. Lurie Comprehensive Cancer Center Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Nicholas McWilliams    312-695-1334    nicholas.mcwilliams@northwestern.edu   
Principal Investigator: Mark Agulnik, MD         
United States, Maryland
National Cancer Institute Not yet recruiting
Bethesda, Maryland, United States, 20892
Contact: Donna Bernstein    240-760-6189    bernsted@mail.nih.gov   
Principal Investigator: John Glod, MD         
United States, Massachusetts
Dana Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Sara Solomon    617-582-7503    ssolomon1@partners.org   
Contact: Julie Field    617-632-6708    julie_field@dfci.harvard.edu   
Principal Investigator: Katherine Thornton, MD         
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Patty Harvey       harveypj@med.umich.edu   
Principal Investigator: Scott Schuetze         
United States, Minnesota
Mayo Clinic Clinical Trial Referral Office Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Referral Office    855-776-0015      
Principal Investigator: Amit Mahipal, MBBS         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Cherly Callahan    314-286-2584    callahanc@wustl.edu   
Principal Investigator: Brian Van Tine, M.D.         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Ana Sera    212-342-0248    as5713@cumc.columbia.edu   
Principal Investigator: Gary Schwart         
Memorial Sloan-Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Contact: Natasha Martin    646-888-4339    martinn@mskcc.org   
Principal Investigator: Sandra D'Angelo, MD         
United States, Ohio
Ohio State University Not yet recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: David Liebner, MD         
United States, Tennessee
Vanderbilt Recruiting
Nashville, Tennessee, United States, 37212
Contact: Anna Dumont    615-936-5173    anna.dumont@vumc.org   
Principal Investigator: Vicki Keedy, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact    713-792-3626    daraujo@mdanderson.org   
Principal Investigator: Deijka Aruajo, MD         
United States, Washington
Fred Hutch Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Laura Wood    206-606-1236    lmwood@seattlecca.org   
Principal Investigator: Michael Wagner, MD         
Canada, Ontario
Princess Margaret Cancer Centre Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Aileen Trang       aileen.trang@uhn.ca   
Principal Investigator: Albiruni G Razak, MD         
France
Institut Bergonie Not yet recruiting
Bordeaux, France
Contact: Stephanie Louchet       s.louchet@bordeaux.unicancer.fr   
Principal Investigator: Maud Toulmonde, MD         
Leon Berard Not yet recruiting
Lyon, France, 69373
Contact: Pauline Linard       pauline.linard@lyon.unicancer.fr   
Principal Investigator: Jeans-Yves Blay, MD         
Spain
Vall D'Hebron Not yet recruiting
Barcelona, Spain, 119-129
Contact: Meritxell Soler       msoler@vhio.net   
Principal Investigator: Claudia Valverde, 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         
United Kingdom
UCLH Not yet recruiting
London, United Kingdom, NW1 2PG
Contact: Sarah Taylor       sarah.tayloe83@nhs.net   
Principal Investigator: Sandra Strauss, MD         
The Christie NHS Foundation Trust Not yet recruiting
Manchester, United Kingdom, M20 4BX
Contact: Shweta Vyas    +44 (0) 161 918 2323    Shweta.vyas@christie.nhs.uk   
Principal Investigator: Fiona Thistlethwaite, MD         
Sponsors and Collaborators
Adaptimmune
Investigators
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Principal Investigator: Deijka Aruajo, MD MD Anderson Cancer Center; Houston TX 77030

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Responsible Party: Adaptimmune
ClinicalTrials.gov Identifier: NCT04044768     History of Changes
Other Study ID Numbers: ADP 0044-002
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019

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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
Additional relevant MeSH terms:
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Sarcoma
Liposarcoma
Sarcoma, Synovial
Liposarcoma, Myxoid
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Adipose Tissue
Neoplasms, Connective Tissue