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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

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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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: November 4, 2019
Last Verified: November 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