A Phase 3, Randomized, Double-blind, Placebo-controlled study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally-advanced or Metastatic NY-ESO-1 + Synovial Sarcoma Subjects Following First-line Systemic Anti-cancer Therapy

Long title

A Phase 3, Randomized, Double-blind, Placebo-controlled study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally-advanced or Metastatic NY-ESO-1 + Synovial Sarcoma Subjects Following First-line Systemic Anti-cancer Therapy

Date receipt dossier

EudraCT number

2018-000824-32

Company / Sponsor

Immune Design

Phase

III

Treated organism

Humans

Indication category

Cancer therapy

Disease

Synovial sarcomas

Therapeutic approach

Immunotherapy

Genetic modification

Replication deficient lentiviral vector encoding NY-ESO-1 cancer testis antigen

Method of transfer of nucleic acid of interest

not applicable

Administered biological material

Recombinant replication defective lentiviral vector (LV305)

Route of administration

Subcutaneous

Locations in Belgium

UZ Leuven

Type of procedure

Contained use only

Current status

Under evaluation

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