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Clinical Trial NCT03967223 (IGNYTE-ESO) for Neoplasms is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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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 (IGNYTE-ESO) Phase 2 103 Master Protocol
Clinical Trial NCT03967223 (IGNYTE-ESO) is designed to study Treatment for Neoplasms. It is a Phase 2 interventional study that is active, not recruiting, having started on 31 December 2019, with plans to enroll 103 participants. Led by USWM CT, LLC, it is expected to complete by 31 July 2026. The latest data from ClinicalTrials.gov was last updated on 25 February 2026.
Brief Summary
This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors.
Detailed Description
New York esophageal antigen-1 (NY-ESO-1) and LAGE-1a antigens are tumor-associated proteins that have been found in several tumor types. Clinical trials using adoptively transferred T cells directed against NY-ESO-1/LAGE-1a have shown objective responses. Letetresgene autoleucel (lete-cel, GSK3377794) is the first generation of NY-ESO-1 specific T-cell receptor engineered T cells. This is a master protocol investigat...Show More
Official Title
Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, Alone or in Combination With Other Agents, in HLA-A2+ Participants With NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO)
Conditions
NeoplasmsOther Study IDs
- IGNYTE-ESO
- 208467
NCT ID Number
Start Date (Actual)
2019-12-31
Last Update Posted
2026-02-25
Completion Date (Estimated)
2026-07-31
Enrollment (Estimated)
103
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Keywords
Adoptive T-cell therapy
Advanced metastatic disease
Advanced unresectable disease
Synovial sarcoma
Myxoid/round cell liposarcoma
GSK3377794
Positive solid tumors
T-cell receptors
Leukapheresis
Letetresgene autoleucel
Lete-cel
Advanced metastatic disease
Advanced unresectable disease
Synovial sarcoma
Myxoid/round cell liposarcoma
GSK3377794
Positive solid tumors
T-cell receptors
Leukapheresis
Letetresgene autoleucel
Lete-cel
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalSubstudy 1: lete-cel in previously untreated advanced (metastatic or unresectable) SS or MRCLS Eligible participants will be leukapheresed to manufacture engineered T cells. Participants will then receive letetresgene autoleucel. | Letetresgene autoleucel (lete-cel, GSK3377794) letetresgene autoleucel will be administered. Fludarabine Fludarabine will be used as the lymphodepleting chemotherapy Cyclophosphamide Cyclophosphamide will be used as the lymphodepleting chemotherapy. |
ExperimentalSubstudy 2: lete-cel in advanced (metastatic or unresectable) SS or MRCLS post anthracycline chemo Eligible participants will be leukapheresed to manufacture engineered T cells. Participants will then receive letetresgene autoleucel. | Letetresgene autoleucel (lete-cel, GSK3377794) letetresgene autoleucel will be administered. Fludarabine Fludarabine will be used as the lymphodepleting chemotherapy Cyclophosphamide Cyclophosphamide will be used as the lymphodepleting chemotherapy. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Substudy 1: Overall response rate (ORR) | 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. | Until disease progression (up to 5 years) |
Substudy 2: Overall response rate (ORR) as assessed by central independent review | 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. | Up to 5 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Substudy 1 and 2: Time to response (TTR) | 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. | Until disease progression (up to 5 years) |
Substudy 1 and 2: Duration of response (DOR) | 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. | Until disease progression (up to 5 years) |
Substudy 1 and 2: Disease control rate (DCR) | 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. | Until disease progression (up to 5 years) |
Substudy 1 and 2: Progression free survival (PFS) | 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. | Until disease progression (up to 5 years) |
Substudy 1 and 2: Frequency of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) according to severity | 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. | Until disease progression (up to 5 years) |
Substudy 1 and 2: Number of participants with replication competent lentivirus (RCL) | RCL exposure will be assessed by polymerase chain reaction (PCR) based assay. | Until disease progression (up to 5 years) |
Substudy 1 and 2: Number of participants with insertional oncogenesis (IO) | Peripheral blood mononuclear cells (PBMC) samples will be collected for monitoring insertional oncogenesis by PCR for gene modified cells in the blood. | Until disease progression (up to 5 years) |
Substudy 2: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis parameters | Blood and urine samples will be collected for assessment of hematology, clinical chemistry and urinalysis parameters. | Until disease progression (up to 5 years) |
Substudy 1 and 2: Maximum transgene expansion (Cmax) of letetresgene autoleucel | Whole blood samples will be collected at indicated time points for evaluation of Cmax. | Until disease progression (up to 5 years) |
Substudy 1 and 2: Time to Cmax (Tmax) of letetresgene autoleucel | Whole blood samples will be collected at indicated time points for evaluation of Tmax. | Until disease progression (up to 5 years) |
Substudy 1 and 2: Area under the concentration/persistence time curve from zero to time t (AUC[0-t]) of letetresgene autoleucel | Whole blood samples will be collected at indicated time points for evaluation of AUC(0-t). | Until disease progression (up to 5 years) |
Substudy 2: Overall response rate (ORR) as determined by the local investigators | 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 determined by the local investigators. | Up to 5 years |
Substudy 2: Overall Survival (OS) | Overall Survival is defined as the interval of time between the date of T-cell infusion and the date of death. | Up to 5 years |
Substudy 2: Number of participants with positive anti-drug antibodies (ADA) and titers of ADA against letetresgene autoleucel | Serum samples will be collected to analyze for the presence of ADAs using validated immunoassays. | Up to 36 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Minimum Age
10 Years
Eligible Sexes
All
- Participant must be greater than or equal to 10 years of age on the day of signing informed consent.
- Participant scheduled to receive clinical drug product supply must also weigh ≥40 kg
- Participant must be positive for HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 alleles by a designated central laboratory
- Participant's tumor is positive for NY-ESO-1 expression by a designated central laboratory.
- Participant has a diagnosis of synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS)
- Performance status: dependent on age - Lansky > 60, Karnofsky > 60, Eastern Cooperative Oncology Group 0-1.
- Participant must have adequate organ function and blood cell counts, within 7 days prior to leukapheresis.
- At time of treatment, participant has measurable disease according to RECIST v1.1.
- Male or female. Contraception requirements will apply at the time of leukapheresis and treatment.
- Consultation for prior history per protocol specifications.
- Central nervous system metastases.
- Any other prior malignancy that is not in complete remission.
- Clinically significant systemic illness (Serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction, that in the judgment of the Investigator would compromise the participant's ability to tolerate protocol therapy or significantly increase the risk of complications).
- Prior or active demyelinating disease.
- History of chronic or recurrent (within the last year prior to leukapheresis) severe autoimmune or immune mediated disease (e.g. Crohn's disease, systemic lupus) requiring steroids or other immunosuppressive treatments.
- Previous treatment with genetically engineered NY-ESO-1-specific T cells.
- Previous NY-ESO-1 vaccine or NY-ESO-1 targeting antibody.
- Prior gene therapy using an integrating vector.
- Previous allogeneic hematopoietic stem cell transplant.
- Washout periods for prior radiotherapy and systemic chemotherapy must be followed.
- Participant had major surgery in less than or equal to 28 days of first dose of study intervention.
- Prior radiation exceeds protocol specified limits.
USWM CT, LLCNo contact data.
38 Study Locations in 7 Countries
California
City of Hope National Medical Center, Duarte, California, 91010, United States
Stanford Hospital and Clinics, Stanford, California, 94305, United States
Colorado
Sarah Cannon Research Institute, Denver, Colorado, 80218, United States
Florida
Mayo Clinic Jacksonville, Jacksonville, Florida, 32224, United States
Illinois
University of Chicago, Chicago, Illinois, 60637, United States
Iowa
University of Iowa College of Medicine, Iowa City, Iowa, 52242-1009, United States
Massachusetts
Dana Farber Cancer Institute, Boston, Massachusetts, 02114, United States
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
Michigan
University of Michigan Medical Center, Ann Arbor, Michigan, 48109, United States
Minnesota
Minnesota Oncology Hematology, Minneapolis, Minnesota, 55455, United States
Mayo Clinic Rochester, Rochester, Minnesota, 55905, United States
Missouri
Washington University, St Louis, Missouri, 63110, United States
New York
Memorial Sloan Kettering cancer center, New York, New York, 10065, United States
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States
Ohio
Ohio State University-Columbus, Columbus, Ohio, 43210, United States
Oregon
Oregon Health and Science University, Portland, Oregon, 97239, United States
Pennsylvania
University of Pittsburgh, Hillman Cancer Centre, Pittsburgh, Pennsylvania, 15232, United States
Tennessee
Sarah Cannon Research Institute, Nashville, Tennessee, 37203, United States
Texas
University Of Texas Southwestern Medical Center, Dallas, Texas, 75390-8565, United States
University of Texas Southwestern Medical Center, Dallas, Texas, 75390-9063, United States
Utah
University of Utah, Salt Lake City, Utah, 84112, United States
Virginia
Virginia Commonwealth University, Richmond, Virginia, 23298, United States
Washington
Fred Hutchinson Cancer Research, Seattle, Washington, 98109-1024, United States
Wisconsin
Froedtert Hospital, Milwaukee, Wisconsin, 53226, United States
Ontario
Princess Margaret Cancer Centre, Toronto, Ontario, M5G 2M9, Canada
Quebec
CIUSSS de L'Est-De-Lile-De-Montreal, Montreal, Quebec, H1T 2M4, Canada
Centre Léon Bérard, Lyon, 69373, France
CHU de Bordeaux GH Sud Hôpital Haut Lévêque, Pessac, 33604, France
Lombardy
Fondazione IRCCS Instituto Nazionale Dei Tumori, Milan, Lombardy, 20133, Italy
Ircss Istituto Clinico Humanitas, Rozzano (MI), Lombardy, 20089, Italy
The Netherlands Cancer Institute, Amsterdam, 1066 CX, Netherlands
Hospital Santa Creu Y Sant Pau, Barcelona, 08025, Spain
Ico Duran y Reynals l'Hospitalet de Llobrega, Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, 28040, Spain
Hospital Virgen Del Rocio, Seville, 41013, Spain
Royal Marsden Hospital, London, SW3 6JJ, United Kingdom
University College Hospital-London, London, WC1E 6AG, United Kingdom
Christie Hospital NHS Foundation Trust, Manchester, M20 4BX, United Kingdom