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)

Conditions

Advanced Synovial Sarcoma, Myxoid/Round Cell Liposarcoma

Brief summary

Overall Response Rate (ORR) per RECIST v1.1 by independent review in Cohort 1.

Detailed description

For Cohort 1 and across Cohorts (overall) separately for both all subjects and synovial sarcoma (SS) only, and in addition Cohort 2 and 3 combined (for SS only):: • Adverse events (AEs) including serious adverse events (SAEs) • Incidence, severity and duration of the AEs of special interest • Replication Competent Lentivirus (RCL) • T cell Clonality and Insertional oncogenesis (IO), Across Cohorts separately for both all subjects and synovial sarcoma (SS) only,and in addition Cohort 2 and 3 combined (for SS only): •Overall Response Rate (ORR) per RECIST v1.1 by independent review. For Cohort 1 and across Cohorts (overall) separately for both all subjects and synovial sarcoma (SS) only,and in addition Cohort 2 and 3 combined (for SS only). Please refer protocol for full information, For Cohort 1 and across cohorts (overall) separately for all subjects and SS only, and in addition Cohorts 2 and 3 combined (SS only): • Retention of additional tumor tissue during Pre-screening to enable development and validation of the MAGE-A4 antigen expression companion diagnostic assay, For Cohort 1 and across Cohorts (overall) separately for all subjects and SS only, and in addition Cohorts 2 and 3 combined (SS only): •Peak persistence and other relevant PK parameters of ADP-A2M4 cells

Related papers

No related papers found yet.

Interventions

DRUGAfamitresgene autoleucel

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Response Rate (ORR) per RECIST v1.1 by independent review in Cohort 1.	—

Secondary

Measure	Time frame
For Cohort 1 and across Cohorts (overall) separately for both all subjects and synovial sarcoma (SS) only, and in addition Cohort 2 and 3 combined (for SS only):: • Adverse events (AEs) including serious adverse events (SAEs) • Incidence, severity and duration of the AEs of special interest • Replication Competent Lentivirus (RCL) • T cell Clonality and Insertional oncogenesis (IO), Across Cohorts separately for both all subjects and synovial sarcoma (SS) only,and in addition Cohort 2 and 3 combined (for SS only): •Overall Response Rate (ORR) per RECIST v1.1 by independent review. For Cohort 1 and across Cohorts (overall) separately for both all subjects and synovial sarcoma (SS) only,and in addition Cohort 2 and 3 combined (for SS only). Please refer protocol for full information, For Cohort 1 and across cohorts (overall) separately for all subjects and SS only, and in addition Cohorts 2 and 3 combined (SS only): • Retention of additional tumor tissue during Pre-screening to en	—

Measure

Time frame

For Cohort 1 and across Cohorts (overall) separately for both all subjects and synovial sarcoma (SS) only, and in addition Cohort 2 and 3 combined (for SS only):: • Adverse events (AEs) including serious adverse events (SAEs) • Incidence, severity and duration of the AEs of special interest • Replication Competent Lentivirus (RCL) • T cell Clonality and Insertional oncogenesis (IO), Across Cohorts separately for both all subjects and synovial sarcoma (SS) only,and in addition Cohort 2 and 3 combined (for SS only): •Overall Response Rate (ORR) per RECIST v1.1 by independent review. For Cohort 1 and across Cohorts (overall) separately for both all subjects and synovial sarcoma (SS) only,and in addition Cohort 2 and 3 combined (for SS only). Please refer protocol for full information, For Cohort 1 and across cohorts (overall) separately for all subjects and SS only, and in addition Cohorts 2 and 3 combined (SS only): • Retention of additional tumor tissue during Pre-screening to en

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Countries

France, Spain

Outcome results

None listed