Trial · NCT03967223
Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors
NCT03967223, Phase 2, Active not recruiting, USWM CT, LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors. Trials, record NCT03967223. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03967223
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors
- NCT number
- NCT03967223
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 103 participants, actual
- Lead sponsor
- USWM CT, LLC
- Conditions
- Neoplasms
- Interventions
- Letetresgene autoleucel (lete-cel, GSK3377794), Fludarabine, Cyclophosphamide
- First posted
- 2019-05-30
- Last updated
- 2026-08-11
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Substudy 1: Overall response rate (ORR) | Until disease progression (up to 5 years) | Overall response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) relative to the total number of participants within the analysis population at any time per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. as determined by the local investigators. |
| Primary | Substudy 2: Overall response rate (ORR) as assessed by central independent review | Up to 5 years | Overall response rate is defined as the percentage of participants with a confirmed CR or PR relative to the total number of participants within the analysis population at any time per RECIST v1.1. as assessed by central independent review. |
| Secondary | Substudy 1 and 2: Time to response (TTR) | Until disease progression (up to 5 years) | Time to response is defined as time from date of T-cell administration to first documented evidence of confirmed (CR or PR) as assessed by local investigators per RECIST v1.1. |
| Secondary | Substudy 1 and 2: Duration of response (DOR) | Until disease progression (up to 5 years) | Duration of response is defined as, in the subset of participants who show a confirmed CR or PR as assessed by local investigators, the time from first documented evidence of CR or PR until the first documented sign of disease progression or death. |
| Secondary | Substudy 1 and 2: Disease control rate (DCR) | Until disease progression (up to 5 years) | Disease control rate is defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) with minimal 12 weeks duration relative to the total number of participants within the analysis population at the time of primary analysis as determined by Investigators per RECIST v1.1. |
| Secondary | Substudy 1 and 2: Progression free survival (PFS) | Until disease progression (up to 5 years) | Progression free survival is defined as the time from the date of T-cell administration until first documented sign of disease progression per RECIST v1.1, or death. |
| Secondary | Substudy 1 and 2: Frequency of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) according to severity | Until disease progression (up to 5 years) | AEs, SAEs and AESIs will be collected. Severity of AEs and SAEs will be summarized using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0. |
| Secondary | Substudy 1 and 2: Number of participants with replication competent lentivirus (RCL) | Until disease progression (up to 5 years) | RCL exposure will be assessed by polymerase chain reaction (PCR) based assay. |
| Secondary | Substudy 1 and 2: Number of participants with insertional oncogenesis (IO) | Until disease progression (up to 5 years) | Peripheral blood mononuclear cells (PBMC) samples will be collected for monitoring insertional oncogenesis by PCR for gene modified cells in the blood. |
| Secondary | Substudy 2: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis parameters | Until disease progression (up to 5 years) | Blood and urine samples will be collected for assessment of hematology, clinical chemistry and urinalysis parameters. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT03967223
GET https://conductscience.org/api/trials/v1/NCT03967223/registered