Trials / Terminated
TerminatedNCT05943990
Study of GSK3845097 in Previously Treated Participants With Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
Assessment of Safety and Recommended Phase 2 Dose of Autologous T Cells Engineered With an Affinity-enhanced TCR Targeting NY ESO 1 and LAGE 1a, and Co-expressing the dnTGF-βRII (GSK3845097) in Participants With NY ESO 1 and/or LAGE 1a Positive Previously Treated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Adaptimmune · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To assess the safety, tolerability and determine recommended phase 2 dose (RP2D) of GSK3845097 in HLA-A\*02:01, HLA-A\*02:05 and/or HLA-A\*02:06 positive participants with New York esophageal squamous cell carcinoma (NY-ESO)-1 and/or Cancer testis antigen 2 (LAGE-1a) positive, previously treated, advanced (metastatic or unresectable) Synovial Sarcoma (SS) and Myxoid/Round Cell Liposarcoma (MRCLS).
Detailed description
This study is a substudy of the Master record - (209012) NCT04526509.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GSK3845097 | GSK3845097 was administered. |
| DRUG | Cyclophosphamide | Cyclophosphamide was administered as lymphodepleting chemotherapy. |
| DRUG | Fludarabine | Fludarabine was administered as lymphodepleting chemotherapy. |
Timeline
- Start date
- 2020-12-21
- Primary completion
- 2022-10-24
- Completion
- 2022-10-24
- First posted
- 2023-07-13
- Last updated
- 2024-11-13
- Results posted
- 2024-03-18
Locations
21 sites across 6 countries: United States, Australia, Canada, Germany, Netherlands, Sweden
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05943990. Inclusion in this directory is not an endorsement.