CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 52 enrolled
Drug / intervention
afamitresgene autoleucel (previously ADP-A2M4)genetic
Likely dose
1.0 × 10^9 to 10 × 10^9 transduced cells, single intravenous infusionAI-extracted
Key inclusion· 7
  • ✓Age 16 to 75 years (10 years at selected sites)
  • ✓Confirmed diagnosis of advanced synovial sarcoma or myxoid/round cell liposarcoma
  • ✓Prior treatment with anthracycline or ifosfamide-containing regimen
  • ✓Measurable disease by RECIST v1.1 prior to lymphodepletion
Key exclusion· 12
  • ✕HLA-A*02:05 in either allele
  • ✕Prior or planned cytotoxic chemotherapy, TKI, immunotherapy, checkpoint inhibitors, vaccine, or integrating vector gene therapy before leukapheresis or lymphodepletion
  • ✕Prior or planned corticosteroids or immunosuppressive therapy before leukapheresis
  • ✕Prior or planned allogeneic hematopoietic stem cell transplant before leukapheresis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04044768
NCT04044768Phase 2Active
CompareCT.gov

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

USWM CT, LLC·interventional·Posted Aug 5, 2019·Updated Feb 6, 2026

In Brief

A Phase 2 clinical trial evaluating afamitresgene autoleucel (previously ADP-A2M4) for Synovial Sarcoma and Myxoid Liposarcoma. Active but no longer recruiting, targeting 52 participants across 26 sites in 5 countries.

Detailed Summary

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) .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSynovial Sarcoma, Myxoid Liposarcoma
CountriesCanada, France, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2Active
2020202120222023202420252026202720282029203020312032203320342035203620372038
First PostedAug 5, 2019
Enrollment StartAug 13, 2019
Primary CompletionAug 29, 2021
Study CompletionApr 1, 2038
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.9 years ago

Interventions

afamitresgene autoleucel (previously ADP-A2M4)genetic

Single infusion of autologous genetically modified afamitresgene autoleucel (previously ADP-A2M4) Dose: 1.0 x109 to 10x109 transduced by a single intravenous infusion