Neoplasms Clinical Trial
— IGNYTE-ESOOfficial 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)
Verified date | April 2024 |
Source | Adaptimmune |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors.
Status | Active, not recruiting |
Enrollment | 103 |
Est. completion date | July 31, 2026 |
Est. primary completion date | August 28, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | CIUSSS de L'Est-De-Lile-De-Montreal | Montreal | Quebec |
Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
France | Centre Léon Bérard | Lyon cedex 08 | |
France | CHU de Bordeaux GH Sud Hôpital Haut Lévêque | Pessac cedex | |
Italy | Fondazione IRCCS Instituto Nazionale Dei Tumori | Milano | Lombardia |
Italy | Ircss Istituto Clinico Humanitas | Rozzano (MI) | Lombardia |
Netherlands | The Netherlands Cancer Institute | Amsterdam | |
Spain | Hospital Santa Creu Y Sant Pau | Barcelona | |
Spain | Ico Duran y Reynals l'Hospitalet de Llobrega | Hospitalet de Llobregat, Barcelona | |
Spain | Hospital Universitario Fundación Jiménez Díaz | Madrid | |
Spain | Hospital Virgen Del Rocio | Sevilla | |
United Kingdom | Royal Marsden Hospital | London | |
United Kingdom | University College Hospital-London | London | |
United Kingdom | Christie Hospital NHS Foundation Trust | Manchester | |
United States | University of Michigan Medical Center | Ann Arbor | Michigan |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | University of Chicago | Chicago | Illinois |
United States | Ohio State University-Columbus | Columbus | Ohio |
United States | University Of Texas Southwestern Medical Center | Dallas | Texas |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Sarah Cannon Research Institute | Denver | Colorado |
United States | City of Hope National Medical Center | Duarte | California |
United States | Duke University Medical Center | Durham | North Carolina |
United States | University of Iowa College of Medicine | Iowa City | Iowa |
United States | Mayo Clinic Jacksonville | Jacksonville | Florida |
United States | Froedtert Hospital | Milwaukee | Wisconsin |
United States | Minnesota Oncology Hematology | Minneapolis | Minnesota |
United States | Sarah Cannon Research Institute | Nashville | Tennessee |
United States | Memorial Sloan Kettering cancer center | New York | New York |
United States | University of Pittsburgh, Hillman Cancer Centre | Pittsburgh | Pennsylvania |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | Mayo Clinic Rochester | Rochester | Minnesota |
United States | Washington University | Saint Louis | Missouri |
United States | University of Utah | Salt Lake City | Utah |
United States | Fred Hutchinson Cancer Research | Seattle | Washington |
United States | Stanford Hospital and Clinics | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Adaptimmune |
United States, Canada, France, Italy, Netherlands, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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