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Clinical Trial 20251

Cancer Type: Immunotherapy
Study Type: Treatment
NCT#: NCT04044768

Phase: Phase II
Principal Investigator: Druta, Mihaela

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study 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 (SPEARHEAD 1 Study)

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.

Objective

Primary: To evaluate the efficacy of autologous genetically modified T cells (ADP-A2M4) in HLA-A*02 positive subjects with MAGE-A4 expressing advanced synovial sarcoma or MRCLS Secondary: To evaluate the safety and tolerability of autologous genetically modified T cells (ADP-A2M4) in HLA-A*02 positive subjects with MAGE-A4 expressing advanced synovial sarcoma or MRCLS To evaluate the efficacy of autologous genetically modified T cells (ADP-A2M4) in HLA-A*02 positive subjects with MAGE-A4 expressing advanced synovial sarcoma or MRCLS Development and validation of an in vitro diagnostic (IVD) assay for the screening of tumor antigen expression for regulatory approval Characterize the in vivo cellular pharmacokinetics (PK) profile of ADPA2M4 cells Exploratory: To evaluate changes in health-related outcomes following treatment with ADPA2M4 Characterize subject peripheral blood, which includes, but is not limited to: transduced T cells (ADP-A2M4), nontransduced T cells, serum and/or plasma pre and post-T cell infusion, to understand factors that can influence response or resistance to ADP-A2M4 therapy. Characterize the tumor and tumor microenvironment pre and post- T cell infusion to understand tumor driven determinants of response and resistance to ADP-A2M4 therapy

Treatments

Therapies

Chemotherapy (NOS); Immunotherapy; Therapy (NOS)

Medications

ADP-A2M4 (); CNTO 328 (Siltuximab); Calcium Chloride (); G-CSF (); MESNA (); Magnesium Sulfate (); Siltuximab (); Tocilizumab (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Inclusion Criteria

  • Between 16 and 75 years of age
  • Diagnosis of advanced synovial sarcoma 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.
  • Positive for HLA-A*02:01, HLA-A*02:03 or HLA-A*02:06 allele via Adaptimmune designated central laboratory testing. HLA-A*02 alleles having the same protein sequence as these alleles in the peptide binding domains (P group) will also be included. Other HLA-A*02 alleles may be eligible after ajudication with the sponsor
  • Tumor shows MAGE-A4 expression confirmed by central laboratory.
  • ECOG Performance Status of 0 or1.
  • Left ventricular ejection fraction (LVEF) greater than or equal to 50%
  • Other protocol defined Inclusion criteria may apply

    • Exclusion Criteria

  • Positive for HLA-A*02:05 in either allele; HLA-A*02 alleles having the same protein sequence as HLA-A*02:05 in the peptide binding domains (P groups) will also be excluded.
  • 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
  • Other protocol defined Exclusion criteria may apply.

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