Trial · NCT05993299
Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
NCT05993299, Phase 2, Completed, USWM, LLC (dba US WorldMeds); results first posted 2023-10-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma. Trials, record NCT05993299. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05993299
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
- NCT number
- NCT05993299
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- USWM, LLC (dba US WorldMeds)
- Conditions
- Neoplasms
- Interventions
- Letetresgene autoleucel, Cyclophosphamide, Fludarabine
- First posted
- 2023-08-15
- Last updated
- 2026-09-02
- Results first posted
- 2023-10-16
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Up to approximately 36 months | ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via investigator assessment per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 relative to the total number of participants in the analysis population. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). 95% CI is based on Clopper-Pearson exact confidence interval. |
| Secondary | Time to Response (TTR) | Up to approximately 54 months | Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). |
| Secondary | Duration of Response (DOR) | Up to approximately 54 months | Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease as assessed by local investigators, or death among participants with a confirmed response per RECIST 1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). |
| Secondary | Disease Control Rate (DCR) | Up to approximately 36 months | DCR is defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) with a minimal 12 weeks (84 days ± 7 day window) duration relative to the total number of participants within the analysis population at the time of primary analysis as determined by local investigators per RECIST v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. The disease progression (PD) is defined as the date of radiological disease progression based on imaging data per RECIST v1.1. 95% CI is based on Clopper-Pearson exact confidence interval. |
| Secondary | Progression Free Survival (PFS) | Up to approximately 54 months | PFS is defined as the interval of time between from the date of T-cell infusion to the earliest date of radiological progression of disease (PD) as assessed by local investigator per RECIST v1.1, or death due to any cause. The PD is defined as the date of radiological disease progression based on imaging data per RECIST v1.1. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Up to approximately 54 months | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. |
| Secondary | Number of Participants With AEs of Special Interest (AESIs) | Up to approximately 54 months | An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. AESIs included cytokine release syndrome (CRS), hematopoietic cytopenias (including pancytopenia and aplastic anemia), graft vs host disease (GVHD), ICANS, Guillain-Barre syndrome, treatment-related inflammatory response at tumor site(s), and neutropenia Grade 4 lasting ≥28 days. |
| Secondary | Number of Participants With TEAEs and TESAEs by Severity | Up to approximately 54 months | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. AEs and SAEs were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences; Grade 5- Death related to AE. |
| Secondary | Number of Participants With AESIs by Severity | Up to approximately 54 months | An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. AESIs included cytokine release syndrome (CRS), hematopoietic cytopenias (including pancytopenia and aplastic anemia), graft vs host disease (GVHD), ICANS, Guillain-Barre syndrome, treatment-related inflammatory response at tumor site(s), and neutropenia Grade 4 lasting ≥28 days. |
| Secondary | Percentage of Participants With Replication Competent Lentivirus (RCL) Positive | Up to approximately 54 months | RCL was monitored using a polymerase chain reaction (PCR)-based assay that detects and measures copies of the gene coding for the vector's envelope protein, namely vesicular stomatitis virus G protein (VSV-G). |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | Up to approximately 36 months | Modified intent-to-treat (mITT) population included all participants who received any dose of Lete-cel. | percentage of participants | NUMBER |
| SECONDARY | Time to Response (TTR) | Up to approximately 54 months | |||
| SECONDARY | Duration of Response (DOR) | Up to approximately 54 months | |||
| SECONDARY | Disease Control Rate (DCR) | Up to approximately 36 months | Modified intent-to-treat (mITT) population included all participants who received any dose of Lete-cel. | Percentage of Participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | Up to approximately 54 months | |||
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Up to approximately 54 months | |||
| SECONDARY | Number of Participants With AEs of Special Interest (AESIs) | Up to approximately 54 months | |||
| SECONDARY | Number of Participants With TEAEs and TESAEs by Severity | Up to approximately 54 months | |||
| SECONDARY | Number of Participants With AESIs by Severity | Up to approximately 54 months | |||
| SECONDARY | Percentage of Participants With Replication Competent Lentivirus (RCL) Positive | Up to approximately 54 months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Letetresgene Autoleucel (Lete-cel) | 80 | 95% Confidence Interval 28.4 to 99.5 | percentage of participants | |
| Disease Control Rate (DCR) | Letetresgene Autoleucel (Lete-cel) | 80.0 | 95% Confidence Interval 28.4 to 99.5 | Percentage of Participants | |
| Maximum Transgene Expansion (Cmax) | Letetresgene Autoleucel (Lete-cel) | 119701.64 | Geometric Coefficient of Variation 68.267 | Copies per microgram genomic DNA | |
| Time to Cmax (Tmax) | Letetresgene Autoleucel (Lete-cel) | 6.90 | Full Range 1.9 to 13.6 | Days | |
| Area Under the Time Curve From Zero to Time 28 Days (AUC[0-28]) | Letetresgene Autoleucel (Lete-cel) | 1911782.96 | Geometric Coefficient of Variation 53.709 | Days*copies per microgram genomic DNA |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Letetresgene Autoleucel (Lete-cel) | 7 | |
| Overall Study | Received T Cell Infusion | Letetresgene Autoleucel (Lete-cel) | 5 | |
| Overall Study | COMPLETED | Letetresgene Autoleucel (Lete-cel) | 1 | |
| Overall Study | NOT COMPLETED | Letetresgene Autoleucel (Lete-cel) | 6 |
Source ClinicalTrials.gov
Adverse events80
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cytokine release syndrome | Immune system disorders | Letetresgene Autoleucel (Lete-cel) | 4 | 7 | 4 |
| other | Graft versus host disease | Immune system disorders | Letetresgene Autoleucel (Lete-cel) | 1 | 7 | 2 |
| other | COVID-19 | Infections and infestations | Letetresgene Autoleucel (Lete-cel) | 3 | 7 | 3 |
| other | Cytomegalovirus infection reactivation | Infections and infestations | Letetresgene Autoleucel (Lete-cel) | 1 | 7 | 1 |
| other | Enterocolitis infectious | Infections and infestations | Letetresgene Autoleucel (Lete-cel) | 1 | 7 | 1 |
| other | Pneumonia | Infections and infestations | Letetresgene Autoleucel (Lete-cel) | 1 | 7 | 1 |
| other | Rhinitis | Infections and infestations | Letetresgene Autoleucel (Lete-cel) | 1 | 7 | 2 |
| other | Alanine aminotransferase increased | Investigations | Letetresgene Autoleucel (Lete-cel) | 3 | 7 | 3 |
| other | Aspartate aminotransferase increased | Investigations | Letetresgene Autoleucel (Lete-cel) | 2 | 7 | 2 |
| other | Blood fibrinogen decreased | Investigations | Letetresgene Autoleucel (Lete-cel) | 2 | 7 | 3 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Letetresgene Autoleucel (Lete-cel) | 1 | 7 |
| Total, other adverse events | Letetresgene Autoleucel (Lete-cel) | 5 | 7 |
| Total, serious adverse events | Letetresgene Autoleucel (Lete-cel) | 4 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05993299
GET https://conductscience.org/api/trials/v1/NCT05993299/events?page=2