Clinical trial · Interventional
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
NCT05943990CI-TRIAL-00082491terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated due to a change in GSK's R\&D priorities.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| GSK3845097 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GSK3845097
- description
- Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive high dose of GSK3845097 after completing lymphodepleting chemotherapy. The first study participant receiving GSK3845097 will receive the total assigned dose as 2 separate infusions 7 days apart, in aliquots of 30% (first infusion) and 70% (second infusion) of the total target dose , respectively. Based on the dose limiting toxicities reported in the first participant, then all subsequent participants treated with GSK3845097 will receive the full dose as a single, i.e., one-time, infusion.
- interventionNames
- Drug: GSK3845097
- Drug: Cyclophosphamide
- Drug: Fludarabine
Primary outcomes (3)
- measure
- Number of Participants With Dose Limiting Toxicities (DLTs)
- timeFrame
- Up to 28 days
- description
- DLT events were graded according to NCI-CTCAE v5.0. DLTs were defined as Grade (Gr) 4 (life-threatening and death) related to GSK3845097 2) Gr 3 (Severe or medically significant) at least possibly related to GSK3845097 and do not resolve to Gr \<=1 (or Baseline) within 7 days from the onset of the event 3) Gr \>=3 non-infectious pneumonitis not responding to oxygen supplementation and systemic steroid treatment 4) Any Gr 3 cytokine release syndrome (CRS) at least possibly related to GSK3845097 that does not improve to Gr \<2 (moderate) toxicity within 7 days with or without dexamethasone 5) Any Gr 4 CRS at least possibly related to study product that does not improve to Gr \<=2 (or Baseline) within 7 days 6) Any Gr 3 or greater neurotoxicity that does not resolve to Gr \<=2 within 72 hours 7) Any Gr \>=3 organ toxicity (exclusive of CRS toxicity) involving major organ systems that persists for \>72 hours and occurs within 28 days of infusion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participant must be \>=18 years of age and weighs ≥40 kg on the day of signing informed consent * Participant must be positive for HLA-A\*02:01, HLA-A\*02:05, and/or HLA-A\*02:06 alleles * Participant's tumor must have tested positive for NY-ESO-1 and/or LAGE-1a expression by a GSK designated laboratory * Performance status: Eastern Cooperative Oncology Group of 0-1 * Participant must have adequate organ function and blood cell counts 7 days prior to leukapheresis * Participant must have measurable disease according to RECIST v1.1. * Participant has advanced (metastatic or unresectable) SS or MRCLS confirmed by local histopathology with evidence of disease-specific translocation * Participant has completed at least one standard of care (SOC) treatment including anthracycline containing regimen unless intolerant to or ineligible to receive the therapy. * Participants who are not candidates to receive anthracycline should have received ifosfamide unless also intolerant to or ineligible to receive ifosfamide. Participants who received neoadjuvant/adjuvant anthracycline or ifosfamide based therapy and progressed will be eligible Exclusion Criteria: * Central nervous system (CNS) metastases, with certain exceptions for CNS metastases in NSCLC as specified in the protocol * Any other prior malignancy that is not in complete remission * Clinically significant systemic illness * Prior or active demyelinating disease * History of chronic or recurrent (within the last year prior to leukapheresis) severe autoimmune or immune mediated disease requiring steroids or other immunosuppressive treatments * Previous treatment with genetically engineered NY-ESO-1-specific T cells, NY-ESO-1 vaccine or NY-ESO-1 targeting antibody * Prior gene therapy using an integrating vector * Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant * Washout periods for prior radiotherapy and systemic chemotherapy must be followed * Major surgery within 4 weeks prior to lymphodepletion * Pregnant or breastfeeding females
References
Publications (0)
Data not yet available
No reference posted for this study.