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


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Trial ID: NCT04044768


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, 2 and 3 ) or MRCLS (Cohort 1) .

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

Stanford Investigator(s)

Kristen N Ganjoo
Kristen N Ganjoo

Professor of Medicine (Oncology)


Key Inclusion Criteria

   - Age ≥16 (10 years at selected sites) and <=75 years

   - Diagnosis of advanced synovial sarcoma (Cohort 1, Cohort 2 and Cohort 3) 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 prior to lymphodepletion

   - HLA-A*02:01, HLA-A*02:02, HLA-A*02:03 or HLA-A*02:06 positive

   - Tumor shows MAGE-A4 expression confirmed by central laboratory. North America Only
   (United States and Canada): Tumor (either an archival specimen or a fresh biopsy)
   shows MAGE-A4 expression of ≥1+ staining in ≥10% of the cells by immunohistochemistry.

   - 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

Key Exclusion Criteria:

   - HLA-A*02:05 in either allele

   - Received or plans to receive the following therapy/treatment prior to leukapheresis or
   lymphodepleting chemotherapy: Cytotoxic chemotherapy, Tyrosine kinase inhibitor (TKI)
   (e.g. pazopanib), Immune therapy (including monoclonal antibody therapy, checkpoint
   inhibitors,), Anti-cancer Vaccine, Gene therapy using an integrating vector (subjects
   who have received a gene therapy using a lentiviral vector may be eligible for the
   study), Corticosteroids or any other immunosuppressive therapy, Investigational
   treatment or interventional clinical trial, Allogeneic hematopoietic stem cell
   transplant, Radiotherapy to the target lesions, Major surgery

   - 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

   - 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.


genetic: afamitresgene autoleucel (previously ADP-A2M4)


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Behnaz Parsien

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