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NCT06703346
Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Treated Advanced (Metastatic or Unresectable) Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
Phase 2 trial testing Letetresgene autoleucel (Lete-Cel (GSK3377794)) in Neoplasms in 87 participants. Participants enrolled and being followed up; not accepting new ones.
1 March 2024
Quick facts
| Lead sponsor | USWM CT, LLC |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 87 |
| Start date | 31 December 2019 |
| Primary completion | 1 March 2024 |
| Estimated completion | 31 July 2026 |
| Sites | 38 locations across France, Italy, Netherlands, United Kingdom, Canada, United States, Spain |
Drugs / interventions tested
- Letetresgene autoleucel (Lete-Cel (GSK3377794)) — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Fludarabine (FLUDARABINE) — full drug profile →
Conditions studied
- Neoplasms — all drugs for Neoplasms →
Sponsor
USWM CT, LLC — full company profile →
Who can join
10 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors. This trial is a sub study of the Master study NCT03967223.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Review of Adoptive Cellular Therapies for the Treatment of Sarcoma.
Fradin JJ, Charlson JA. · · 2025 · cited 3× · PMID 40282478 · DOI 10.3390/cancers17081302
Verify or expand the search:
- PubMed search for NCT06703346
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Neoplasms
Currently open trials in the same condition.
- NCT07438782 — First Time in Human (FTIH) Study to Investigate the Safety and Preliminary Activity of GSK5533524 Alone or in Combinatio · Phase 1 · recruiting
- NCT07382817 — Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for r/r CD94+ T/NK Cell Neoplasms · Phase 1 · recruiting
- NCT07277270 — A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tum · Phase 1 · recruiting
- NCT07257640 — IL-5 CAR-T Cell Therapy for Refractory/Relapsed Eosinophilic Leukemia · Phase 1 · recruiting
- NCT07213609 — A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer · Phase 1, PHASE2 · recruiting
Other USWM CT, LLC trials
Trials by the same sponsor.
- NCT05642455 — SPEARHEAD-3 Pediatric Study · Phase 1, PHASE2 · recruiting
- NCT05601752 — ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURP · Phase 2 · active not recruiting
- NCT03967223 — Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a · Phase 2 · active not recruiting
- NCT04044859 — ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Pos · Phase 1 · active not recruiting
- NCT04044768 — Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma · Phase 2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06703346 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by USWM CT, LLC
- Last refreshed: 8 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06703346.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing