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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 : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Adaptimmune

Tracking Information
First Submitted Date  ICMJE July 9, 2019
First Posted Date  ICMJE August 5, 2019
Last Update Posted Date November 4, 2019
Actual Study Start Date  ICMJE July 24, 2019
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04044768 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2019)
  • 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
  • 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.
  • 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 )
  • Efficacy: Best overall response (BOR) [ Time Frame: 2.5 years ]
    BOR is per RECIST V1.1.
  • 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.
  • 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.
  • 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.
  • Overall Survival (OS) [ Time Frame: 15 years ]
    OS is assessed from date of infusion of ADP-A2M4 up until the date of patient death
  • Quantitation of genetically engineered T-cells in PBMCs [ Time Frame: 2.5 years ]
    Quantitation of genetically engineered T-cells in PBMCs by qPCR
  • 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
  • Quantitation of genetically engineered T-cells in PBMCs [ Time Frame: 2.5 years ]
    Quantitation of genetically engineered T-cells in PBMCs by flow cytometry
  • 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
  • Invitro diagnostic (IVD) assay for screening [ Time Frame: 2.5 years ]
    Development and validation of the MAGE-A4 antigen expression companion diagnostic assay
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Synovial Sarcoma
  • Myxoid Liposarcoma
Intervention  ICMJE Genetic: ADP-A2M4
Autologous genetically modified ADP-A2M4 Dose: 1.0 x109 to 10x109 transduced by a single intravenous infusion
Study Arms  ICMJE Experimental: Autologous genetically modified ADP-A2M4
Intervention: Genetic: ADP-A2M4
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2034
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Deijka Aruajo, MD 713-792-3626 daraujo@mdanderson.org
Listed Location Countries  ICMJE Canada,   France,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04044768
Other Study ID Numbers  ICMJE ADP 0044-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adaptimmune
Study Sponsor  ICMJE Adaptimmune
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Deijka Aruajo, MD MD Anderson Cancer Center; Houston TX 77030
PRS Account Adaptimmune
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP