Trial Search Results

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

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) .

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Adaptimmune

Stanford Investigator(s):

Intervention(s):

  • Genetic: afamitresgene autoleucel (previously ADP-A2M4)

Phase:

Phase 2

Eligibility


Key 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-A*02 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

Key Exclusion Criteria:

   - HLA-A*02:05 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.

Ages Eligible for Study

10 Years - 75 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maria Ahern
650-725-6413
Recruiting