{"entity":{"id":"nct04044768","kind":"trial","name":"Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma","aka":[],"tldr":"A phase 2 trial of Afamitresgene autoleucel in sarcomas, run by USWM CT, LLC, active and no longer recruiting.","summary":"Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma is a phase 2 interventional study registered as NCT04044768 by USWM CT, LLC, with 52 participants enrolled, started 2019-08-13 and due to reach its primary completion in 2021-08-29. Interventions recorded: afamitresgene autoleucel (previously ADP-A2M4). Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04044768","url":"https://clinicaltrials.gov/study/NCT04044768"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sarcoma","liposarcoma","synovial-sarcoma"],"sections":[],"technologies":["tcr-t"],"targets":[],"drugs":["afamitresgene-autoleucel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04044768","phase":"2","setting":"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","sponsor":"USWM CT, LLC","started":"2019-08-13","startedType":"actual","yearReported":2025,"enrolled":52,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Response Rate (ORR) (Cohort 1)","primary":true,"unit":"%","arms":[{"name":"Synovial Sarcoma","n":44,"value":38.6,"note":"95% CI 24.36 to 54.50; Figures from the ClinicalTrials.gov results section (first posted 2025-01-13), not from a publication"},{"name":"MRCLS","n":8,"value":25,"note":"95% CI 3.19 to 65.09"}],"source":"https://clinicaltrials.gov/study/NCT04044768?tab=results"}]},"route":"/trials/nct04044768/","neighbours":{"cancer":[{"id":"liposarcoma","kind":"cancer","name":"Liposarcoma","route":"/cancers/liposarcoma/"},{"id":"sarcoma","kind":"cancer","name":"Sarcomas (soft tissue, bone, GIST)","route":"/cancers/sarcoma/"},{"id":"synovial-sarcoma","kind":"cancer","name":"Synovial sarcoma","route":"/cancers/synovial-sarcoma/"}],"technology":[{"id":"tcr-t","kind":"technology","name":"TCR-T cell therapy","route":"/technologies/tcr-t/"}],"drug":[{"id":"afamitresgene-autoleucel","kind":"drug","name":"Afamitresgene autoleucel","route":"/drugs/afamitresgene-autoleucel/"}]}}