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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2034
  • participants needed
    90
  • sponsor
    Adaptimmune
Updated on 15 February 2022

Summary

This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1 and Cohort 2) or MRCLS (Cohort 1) .

Details
Condition Synovial Sarcoma, Myxoid Liposarcoma
Treatment ADP-A2M4, afamitresgene autoleucel (previously ADP-A2M4)
Clinical Study IdentifierNCT04044768
SponsorAdaptimmune
Last Modified on15 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 16 (10 years at selected sites) and <=75 years
Diagnosis of advanced synovial sarcoma (Cohort 1 and Cohort 2) or myxoid liposarcoma / myxoid round cell liposarcoma (Cohort 1 only) confirmed by cytogenetics
Previously received either an anthracycline or ifosfamide containing regimen
Measurable disease according to RECIST v1.1
HLA-A02 positive
Tumor shows MAGE-A4 expression confirmed by central laboratory
ECOG Performance Status of 0 or1. For subjects aged 10 to 16 years old
Lansky Score 60%
Left ventricular ejection fraction (LVEF) 50%
Note: other protocol defined Inclusion criteria may apply

Exclusion Criteria

HLA-A02:05 in either 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
Symptomatic CNS metastases including leptomeningeal disease
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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