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- | letetresgene autoleucel (GSK3377794) / Adaptimmune
Journal, PD(L)-1 Biomarker, IO biomarker, Metastases: Safety and Tolerability of Letetresgene Autoleucel (Lete-cel; GSK3377794): Pilot Studies in Patients With Advanced Non-Small Cell Lung Cancer. (Pubmed Central) - Nov 22, 2024
Lete-cel was generally well tolerated and had no unexpected AEs. Anti-tumor activity was observed in a limited number of patients.
- letetresgene autoleucel (GSK3377794) / Adaptimmune
PLANNED ANALYSIS OF THE PIVOTAL IGNYTE-ESO TRIAL OF LETE-CEL IN PATIENTS WITH SYNOVIAL SARCOMA OR MYXOID/ROUND CELL LIPOSARCOMA. (Harbor Ballroom) - Nov 9, 2024 - Abstract #CTOS2024CTOS_209;
- letetresgene autoleucel (GSK3377794) / Adaptimmune
Trial completion date, Metastases: 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 (clinicaltrials.gov) - Oct 22, 2024
P2, N=7, Active, not recruiting, Sponsor: Adaptimmune
Anti-tumor activity was observed in a limited number of patients. Trial completion date: Jul 2024 --> Jul 2025
- || letetresgene autoleucel (GSK3377794) / Adaptimmune
Trial primary completion date, Combination therapy: IGNYTE-ESO: 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 (clinicaltrials.gov) - Apr 25, 2024
P2, N=103, Active, not recruiting, Sponsor: Adaptimmune
Trial completion date: Jul 2024 --> Jul 2025 Trial primary completion date: Nov 2022 --> Aug 2024
- letetresgene autoleucel (GSK3377794) / Adaptimmune
Lete-cel in patients with synovial sarcoma or myxoid/round cell liposarcoma: Planned interim analysis of the pivotal IGNYTE-ESO trial. (Hall D2) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3112;
P2
Trial primary completion date: Nov 2022 --> Aug 2024 LD (fludarabine 120 mg/m 2 , cyclophosphamide 2700
- Keytruda (pembrolizumab) / Merck (MSD), letetresgene autoleucel (GSK3377794) / Adaptimmune
Phase classification, Metastases: Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab (clinicaltrials.gov) - Feb 22, 2024
P1/2, N=34, Terminated, Sponsor: GlaxoSmithKline
LD (fludarabine 120 mg/m 2 , cyclophosphamide 2700 Phase classification: P1b/2a --> P1/2
- letetresgene autoleucel (GSK3377794) / Adaptimmune
Optimization of dose and regimen of letetresgene autoleucel for the treatment of synovial sarcoma: simulation of dose dependence and split dosing using quantitative systems pharmacology modeling (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_718;
The optimal spilt-dose regimen among tested was 10% of the dose on day 1, 30% on day 2 and 60% on day 3. Split-dose cell therapy regimens may provide an improved safety profile while delivering comparable efficacy compared to single dose.
- letetresgene autoleucel (GSK3377794) / Adaptimmune
New P2 trial, Metastases: 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 (clinicaltrials.gov) - Aug 15, 2023
P2, N=7, Active, not recruiting, Sponsor: GlaxoSmithKline
- ||||| Keytruda (pembrolizumab) / Merck (MSD), letetresgene autoleucel (GSK3377794) / Adaptimmune
Clinical: 1/ Great to see @BloodAdvances paper re: lete-cel (innate TCR against NY-ESO1, not CAR-T against BCMA) +/- pembro - so important to try to challenge paradigms! Unfortunately, this isn't it. Only 5% of screened #MMsm pts eligible and PFS <6mo generally. https://t.co/rPBIZdx6E6 (Twitter) - Dec 26, 2022
- | Keytruda (pembrolizumab) / Merck (MSD), letetresgene autoleucel (GSK3377794) / Adaptimmune
Journal: Safety and efficacy of letetresgene autoleucel alone or with pembrolizumab for relapsed/refractory multiple myeloma. (Pubmed Central) - Dec 20, 2022
P1
Two responders, but none of the non-responders, exhibited elevated cytokine levels post lete-cel infusion. Lete-cel had a manageable safety profile consistent with other lete-cel studies and demonstrated clear but transient antitumor activity in patients with RRMM.
- | Keytruda (pembrolizumab) / Merck (MSD), letetresgene autoleucel (GSK3377794) / Adaptimmune
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Metastases: Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab (clinicaltrials.gov) - Dec 5, 2022
P1b/2a, N=34, Terminated, Sponsor: GlaxoSmithKline
Lete-cel had a manageable safety profile consistent with other lete-cel studies and demonstrated clear but transient antitumor activity in patients with RRMM. N=54 --> 34 | Trial completion date: May 2025 --> Nov 2022 | Active, not recruiting --> Terminated | Trial primary completion date: May 2025 --> Jun 2022; The study was terminated for reasons pertaining to feasibility
- GSK3845097 / GSK, GSK3901961 / GSK
ZENYTH-ESO: Master protocol to assess the safety and recommended phase II dose of next generation NY-ESO-1-specific TCR T-cells in HLA-A*02 patients with synovial sarcoma, myxoid/round cell liposarcoma and non- small cell lung cancer [Substudy 1 (GSK3901961) and Substudy 2 (GSK3845097)] () - Nov 30, 2022 - Abstract #DKK2022DKK_2198;
P1
Background: Letetresgene autoleucel (lete-cel; GSK3377794) is an autologous T-cell therapy expressing an affinity-enhanced T-cell recep- tor (TCR) to improve recognition of cancer cells expressing NY-ESO-1 and/or LAGE-1a. This master protocol will evaluate the safety and efficacy of next generation NY-ESO-1 specific TCR-T cells in SS/MRCLS or NSCLC.
- GSK3901961 / GSK
ZENYTH-ESO Substudy 1 (GSK3901961), Cohort 1: a first-in-human study to assess the safety and recommended phase II dose of next generation NY-ESO-1-specific TCR T-cells in HLA-A*02 patients with non-small cell lung cancer (Room A2) - Nov 30, 2022 - Abstract #DKK2022DKK_1731;
P1
This study is recruiting. This substudy will evaluate the safety and efficacy of GSK3901961 in NSCLC.
- || letetresgene autoleucel (GSK3377794) / Adaptimmune
Enrollment closed, Combination therapy: IGNYTE-ESO: 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 (clinicaltrials.gov) - Oct 31, 2022
P2, N=103, Active, not recruiting, Sponsor: GlaxoSmithKline
This substudy will evaluate the safety and efficacy of GSK3901961 in NSCLC. Recruiting --> Active, not recruiting
- letetresgene autoleucel (GSK3377794) / Adaptimmune
Biomarker correlates of letetresgene autoleucel (lete-cel; GSK3377794) response in patients with advanced myxoid/round cell liposarcoma (MRCLS) (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_928;
P2
Preliminary gene expression data from the tumors collected at baseline showed enrichment of metabolic pathways in responders and epithelial–mesenchymal transition and fibroblast activation in non-responders. Conclusions These data suggest that higher lete-cel persistence and the association of lete-cel expansion with cytokine upregulation post-infusion, as well as tumor-intrinsic transcriptional features, may have a role in lete-cel response in patients with advanced MRCLS.
- letetresgene autoleucel (GSK3377794) / Adaptimmune, LYL331 / Lyell Immunopharma
Increased potency and functional persistence in vitro of a next-generation NY-ESO-1-specific TCR therapy incorporating Gen-RTM genetic reprogramming technology (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_569;
Conclusions In addition to supporting the hypothesis that genetic reprogramming with Gen-R technology can delay the onset of exhaustion and improve the long-term durable functions of LYL331, these data show that c-Jun overexpression can provide immediate benefits to the NY-ESO-1-specific TCR therapy during primary stimulation in vitro . Based on these promising pre-clinical data, LYL331 may have the potential to improve clinical responses in patients with solid tumor malignancies.
- | NY-ESO-1 TCR / Gilead
Biomarker, Journal, IO biomarker: Biomarker correlates with response to NY-ESO-1 TCR T cells in patients with synovial sarcoma. (Pubmed Central) - Sep 18, 2022
P1
Analysis of tumor samples post-treatment illustrates lete-cel infiltration and a decrease in expression of macrophage genes, suggesting remodeling of the tumor microenvironment. Here we report potential predictive and pharmacodynamic markers of lete-cel response that may inform LDR, cell dose, and strategies to enhance anticancer efficacy.
- letetresgene autoleucel (GSK3377794) / GSK
PROGNOSTIC IMPACT OF NEW YORK ESOPHAGEAL SQUAMOUS CELL CARCINOMA-1 EXPRESSION AND HUMAN LEUKOCYTE ANTIGEN SUBTYPES IN METASTATIC SYNOVIAL SARCOMA () - Sep 9, 2022 - Abstract #CTOS2022CTOS_434;
Assessing efficacy of adoptive T-cell therapies in highly selected patients, versus standard treatment through randomized trials, is difficult. In this context, it is essential to ensure that expression of NY-ESO-1 and HLA*A type does not modify the natural history of the disease.Unadjusted results report a longer OS in patients whose tumors express NY-ESO-1, even if the prognostic impact of this antigen disappears in the multivariate analysis.
- letetresgene autoleucel (GSK3377794) / GSK
Prevalence and clinical characteristics of metastatic synovial sarcoma (mSS) patients with tumours expressing NY-ESO-1 antigen (NY+) and who are HLA-A*02:01, *02:05 or *02:06 allele positive (HLA+): Cohort study from the French sarcoma group (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_1877;
Background Letetresgene autoleucel is a genetically engineered NY-ESO-1–specific TCR T-cell therapy being investigated in mSS patients whose tumours express the NY-ESO-1 antigen and who are HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06 allele positive (NY+/HLA+)...Conclusions Nationally representative prevalence and clinical profile of mSS patients with NY+/HLA+ tumours were previously unknown and have been documented by this study. Among primary tumour samples, no relationship was observed between NY-ESO expression and age of samples, HLA sub-type, or line of treatment.
- ||||| letetresgene autoleucel (GSK3377794) / GSK
Clinical, Interview: #ICYMI: Watch our #ASCO22 interview with @sandrapdangelo @MSKCancerCenter on lete-cel for patients with advanced and metastatic myxoid/round cell liposarcoma https://t.co/JWt7HhzHts (Twitter) - Jun 6, 2022
- ||||| letetresgene autoleucel (GSK3377794) / GSK
Clinical: #ASCO22 #sarcoma @sandrapdangelo presented efficacy and safety of lete-cel in patients with advanced myxoid/round-cell liposarcoma Promising ORR of 40% in ccohort 2, with reasonable durability. (Twitter) - Jun 5, 2022
- ||| letetresgene autoleucel (GSK3377794) / GSK
Excellent presentation from @sandrapdangelo on lete-cel for #MRCLS (Twitter) - Jun 5, 2022
- |||| letetresgene autoleucel (GSK3377794) / GSK
Lete-cel in NY-ESO expressing my pod liposarcoma Excellent results by @sandrapdangelo @MSKSarcoma #asco22 @OncoAlert (Twitter) - Jun 5, 2022
- ||||| letetresgene autoleucel (GSK3377794) / GSK
Clinical: "This is one of the first clinical trials exploring the T-cell construct for MRCLS. I think we’ve come to appreciate that a single dose of lete-cel does offer good response rates," @sandrapdangelo @MSKCancerCenter tells CGTL. #ASCO22 https://t.co/0k7OeSKp3x (Twitter) - Jun 5, 2022
- |||||| letetresgene autoleucel (GSK3377794) / GSK
Clinical: @sandrapdangelo MD presents efficacy and safety for NY-Eso-1 lete-cel - in myxoid/round cell lipo- promising responses and expected safety profile! #immunotherapy #sarcoma #ASCO22 (Twitter) - Jun 4, 2022
- |||||| letetresgene autoleucel (GSK3377794) / GSK
Clinical: #ASCO22 11500 - @sandrapdangelo @MSKCancerCenter study on #Immunotherapy for myxoid/round cell liposarcoma #sarcoma pts by anti-NY-ESO-1 #TCR autologous #Tcell (lete-cel @GSK). Up to 40% of pts responded for median 7.5m. How can we boost responses?Vaccination? Cytokines? (Twitter) - Jun 4, 2022
- letetresgene autoleucel (GSK3377794) / GSK
Primary efficacy and safety of letetresgene autoleucel (lete-cel; GSK3377794) pilot study in patients with advanced and metastatic myxoid/round cell liposarcoma (MRCLS). (Available On Demand) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3069;
P2
This is an open label, study of lete-cel in pts with advanced or metastatic MRCLS following reduced-dose (Cohort 1 [C1]; 30 mg/m2 fludarabine [flu] x 3d + 600 mg/m2 cyclophosphamide [cy] x 3d) or standard dose (Cohort 2 [C2]; 30 mg/m2 flu x 4d + 900 mg/m2 cy x 3d) lymphodepletion (LD). Treatment with a single dose of lete-cel showed anti-tumor activity, including response and long median PFS with an acceptable safety profile in pts with advanced and metastatic MRCLS.
- LYL132 / Lyell Immunopharma, GSK
ZENYTH-ESO: Master protocol to assess the safety and recommended phase II dose of next generation NY-ESO-1-specific TCR T-cells in HLA-A*02 patients with synovial sarcoma and myxoid/round cell liposarcoma [Substudy 3, GSK4427296]. (Available On Demand; 329b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1740;
P1
Analyses will be descriptive. The master protocol is open for recruitment.
- || letetresgene autoleucel (GSK3377794) / Adaptimmune
Trial completion, Trial completion date, Metastases: ADP-0011-007: Letetresgene Autoleucel Engineered T Cells in NY-ESO-1 Positive Participants With Advanced Myxoid/ Round Cell Liposarcoma (clinicaltrials.gov) - Apr 6, 2022
P2, N=23, Completed, Sponsor: GlaxoSmithKline
The master protocol is open for recruitment. Active, not recruiting --> Completed | Trial completion date: Aug 2022 --> Mar 2022
- || Keytruda (pembrolizumab) / Merck (MSD), letetresgene autoleucel (GSK3377794) / Adaptimmune
Enrollment closed, Metastases: Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab (clinicaltrials.gov) - Jan 19, 2022
P1b/2a, N=54, Active, not recruiting, Sponsor: GlaxoSmithKline
Active, not recruiting --> Completed | Trial completion date: Aug 2022 --> Mar 2022 Recruiting --> Active, not recruiting
- | GSK3845097 / GSK, letetresgene autoleucel (GSK3377794) / GSK, ADP-A2M10 / Adaptimmune
Journal: Engineering Cancer Antigen-Specific T Cells to Overcome the Immunosuppressive Effects of TGF-β. (Pubmed Central) - Jan 12, 2022
In this article, we show that exogenous TGF-β inhibited in vitro proliferation and effector functions of human T cells expressing these first-generation high-affinity TCRs, whereas inhibition was reduced or abolished in the case of second-generation TCRs coexpressed with dnTGFβRII (e.g., GSK3845097)...As an example, immunohistochemistry/RNAscope identified TGF-β-positive cells close to T cells in tumor nests and stroma, which had low frequencies of cells expressing IFN-γ in a non-small cell lung cancer setting. Coexpression of dnTGFβRII may therefore improve the efficacy of TCR-transduced T cells.
- letetresgene autoleucel (GSK3377794) / GSK
IGNYTE-ESO: LETETRESGENE AUTOLEUCEL (LETE-CEL; GSK3377794) SAFETY AND ACTIVITY IN HLA-A*02+ PATIENTS WITH SYNOVIAL SARCOMA OR MYXOID/ROUND CELL LIPOSARCOMA (SUBSTUDIES 1 AND 2): A MASTER PROTOCOL ([VIRTUAL]) - Nov 26, 2021 - Abstract #CTOS2021CTOS_343;
P2
Editorial support was provided by Eithne Maguire, PhD, and Katie Crossland, PhD, of Fishawack Indicia, part of Fishawack Health, UK, and funded by GSK. This abstract was first presented at American Society of Clinical Oncology Annual Meeting on June 4 8, 2021.
- letetresgene autoleucel (GSK3377794) / GSK
NY-ESO-1 EXPRESSION PROFILING AND PREVALENCE ASSESSMENT OF TUMOR BIOPSIES FROM PHASE I/II TCR T CELL THERAPY CLINICAL TRIALS IN ADVANCED SYNOVIAL SARCOMA OR MYXOID ROUND CELL LIPOSARCOMA ([VIRTUAL]) - Nov 26, 2021 - Abstract #CTOS2021CTOS_308;
P1, P2
As such, NY-ESO-1 strong staining in both SS and MRCLS indications, in a high percentage of patients evaluated supports the tests utility as an aid in the identification of patients who may be eligible for NY-ESO-1 specific T cells (lete-cel) TCR targeted therapy. NY-ESO-1 expression levels and positive prevalence using a clinical trial IHC assay is consistent with what has been reported in the literature (1,2) and demonstrated consistent nuclear and cytoplasmic staining localization in tumor cells in SS and MRCLS sub-types, which are morphologically distinct forms of cancers arising from soft tissues.
- GSK3845097 / GSK, GSK3901961 / GSK, letetresgene autoleucel (GSK3377794) / GSK
SAFETY AND RECOMMENDED PHASE 2 DOSE OF NEXT GENERATION NY-ESO-1-SPECIFIC TCR T-CELLS IN HLA-A*02 PATIENTS WITH SYNOVIAL SARCOMA OR NON-SMALL CELL LUNG CANCER: MASTER PROTOCOL (SUBSTUDIES 1 AND 2) ([VIRTUAL]) - Nov 26, 2021 - Abstract #CTOS2021CTOS_150;
P1
Editorial support was provided by Eithne Maguire, PhD and Katie Crossland, PhD of Fishawack Indicia, part of Fishawack Health, UK; funded by GSK. This abstract was previously presented at the American Association for Cancer Research (April 10–15 and May 17–21, 2021) and the American Society of Clinical Oncology Annual Meeting (June 4–8, 2021).
- letetresgene autoleucel (GSK3377794) / GSK
SAFETY AND EFFICACY OF LETETRESGENE AUTOLEUCEL (LETE-CEL; GSK3377794) IN ADVANCED MYXOID/ROUND CELL LIPOSARCOMA (MRCLS) FOLLOWING HIGH LYMPHODEPLETION (COHORT 2): INTERIM ANALYSIS ([VIRTUAL]) - Nov 26, 2021 - Abstract #CTOS2021CTOS_32;
P2
The trial is active but no longer recruiting (NCT02992743). MRCLS is included in a separate, ongoing lete-cel study (NCT03967223).
- |||||| letetresgene autoleucel (GSK3377794) / GSK
Cytokine release syndrome: 🚨Very promissing results of letetresgene autoleucel in advanced myxoid/round cell liposarcoma (NY-ESO-1 positive) 🌟durable response 🌟ORR 40% DCR 90% ☠️Tocitity: cytokine release syndrome (30% G3) @sandrapdangelo @MSKSarcoma #CTOS2021 @ctosociety @OncoAlert #sarcoma (Twitter) - Nov 12, 2021
- ||||| letetresgene autoleucel (GSK3377794) / GSK
Clinical: P 31 - SAFETY AND EFFICACY OF LETETRESGENE AUTOLEUCEL (LETE-CEL; GSK3377794) IN ADVANCED MYXOID/ROUND CELL #LIPOSARCOMA (MRCLS) FOLLOWING HIGH LYMPHODEPLETION (COHORT 2): INTERIM ANALYSIS: ORR=40% w HD lymph-depletion https://t.co/J4o6NXOnmv #CTOS2021 @sandrapdangelo #sarcoma (Twitter) - Nov 12, 2021
- Keytruda (pembrolizumab) / Merck (MSD), letetresgene autoleucel (GSK3377794) / GSK
Safety and Efficacy of Letetresgene Autoleucel (lete-cel; GSK3377794) Alone or in Combination with Pembrolizumab in Relapsed and Refractory Multiple Myeloma (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_5563;
P1
Both responses in Arm 2 occurred prior to pembro initiation. The associated safety profile was manageable and consistent with that seen in other lete-cel studies.
- | letetresgene autoleucel (GSK3377794) / Adaptimmune
Trial completion date, Metastases: ADP-0011-007: Letetresgene Autoleucel Engineered T Cells in NY-ESO-1 Positive Participants With Advanced Myxoid/ Round Cell Liposarcoma (clinicaltrials.gov) - Oct 18, 2021
P2, N=23, Active, not recruiting, Sponsor: GlaxoSmithKline
The associated safety profile was manageable and consistent with that seen in other lete-cel studies. Trial completion date: Oct 2021 --> Aug 2022
- letetresgene autoleucel (GSK3377794) / GSK
Biomarker correlates of response in patients with advanced Myxoid/Round Cell Liposarcoma (MRCLS) treated with NY-ESO-1 TCR T cells (Letetresgene autoleucel) (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_397;
P2
Higher AUC0–28d was correlated with Cmax and maximum tumor volume reduction. Trial Registration NCT02992743
- letetresgene autoleucel (GSK3377794) / Adaptimmune
Phase classification, Metastases: ADP-0011-007: Letetresgene Autoleucel Engineered T Cells in NY-ESO-1 Positive Participants With Advanced Myxoid/ Round Cell Liposarcoma (clinicaltrials.gov) - Jul 30, 2021
P2, N=23, Active, not recruiting, Sponsor: GlaxoSmithKline
Trial Registration NCT02992743 Phase classification: P1/2 --> P2
- letetresgene autoleucel (GSK3377794) / GSK
[VIRTUAL] A novel, comprehensive glimpse at NY-ESO-1 expression, mRNA to protein translation, & potential impact on clinical studies () - Jul 22, 2021 - Abstract #ESMO2021ESMO_1509;
NGS was highly correlated to IHC and Sanger sequencing and may be an alternative method for identifying a higher number of tumors that express biomarkers of interest. Our data show a unique platform for comprehensive assessment of disease which may improve patient stratification and management strategies.
- | letetresgene autoleucel (GSK3377794) / Adaptimmune
Enrollment closed, Phase classification, Metastases: ADP-0011-007: Letetresgene Autoleucel Engineered T Cells in NY-ESO-1 Positive Participants With Advanced Myxoid/ Round Cell Liposarcoma (clinicaltrials.gov) - May 26, 2021
P1/2, N=20, Active, not recruiting, Sponsor: GlaxoSmithKline
Our data show a unique platform for comprehensive assessment of disease which may improve patient stratification and management strategies. Recruiting --> Active, not recruiting | Phase classification: P2 --> P1/2
- GSK3845097 / GSK, GSK3901961 / GSK, letetresgene autoleucel (GSK3377794) / GSK
[VIRTUAL] Master protocol to assess safety and recommended phase 2 dose of next generation NY-ESO-1–specific TCR T-cells in HLA-A*02 patients with synovial sarcoma or non-small cell lung cancer (Substudies 1 and 2). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2718;
P1
Exploratory endpoints include laboratory parameters, overall survival, and anti-GSK3901961 or -GSK3845097 titers as applicable . Analyses will be descriptive.
- letetresgene autoleucel (GSK3377794) / GSK
[VIRTUAL] IGNYTE-ESO: A master protocol to assess safety and activity of letetresgene autoleucel (lete-cel; GSK3377794) in HLA-A*02+ patients with synovial sarcoma or myxoid/round cell liposarcoma (Substudies 1 and 2). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1200;
P2
Secondary endpoints include efficacy (time to/duration of response, disease control rate, progression-free survival), safety (adverse event [AE] frequency/severity, serious AEs, AEs of special interest), and pharmacokinetic (maximum transgene expansion [Cmax], time to Cmax, area under the time curve from zero to time t as data permit) . Enrollment began in December 2019.
- letetresgene autoleucel (GSK3377794) / GSK
[VIRTUAL] Safety and efficacy of letetresgene autoleucel (lete-cel; GSK3377794) in advanced myxoid/round cell liposarcoma (MRCLS) following high lymphodepletion (Cohort 2): Interim analysis. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1138;
P1/2, P2
The trial is active but no longer recruiting (NCT02992743) . MRCLS is included in a separate, ongoing lete-cel study (NCT03967223).
- || IMCnyeso / GSK, letetresgene autoleucel (GSK3377794) / GSK
$GSK discontinued $IMCR partnered GSK3537142 (NYESO-ImmTAC), citing "portfolio prioritisation". Meaning $ADAP GSK3377794 is priority? (Twitter) - Apr 28, 2021
- GSK3845097 / GSK, GSK3901961 / GSK, letetresgene autoleucel (GSK3377794) / GSK
[VIRTUAL] Master protocol to assess the safety and recommended Phase 2 dose of next generation NY-ESO-1-specific TCR T-cells in HLA-A*02 patients with synovial sarcoma and non-small cell lung cancer () - Mar 11, 2021 - Abstract #AACR2021AACR_3907;
P1
Exploratory endpoints include laboratory parameters, overall survival, and anti-GSK3901961 and anti-GSK3845097 titers for the respective substudies. The substudies are open and recruiting.
- letetresgene autoleucel (GSK3377794) / Adaptimmune
Phase classification, Enrollment change, Trial completion date, Trial termination, Trial primary completion date: KEYNOTE-487: Letetresgene Autoleucel Engineered T Cells Alone and in Combination With Pembrolizumab in NY-ESO-1 Positive Multiple Myeloma (clinicaltrials.gov) - Feb 25, 2021
P1, N=6, Terminated, Sponsor: GlaxoSmithKline
The substudies are open and recruiting. Phase classification: P2 --> P1 | N=20 --> 6 | Trial completion date: Jan 2023 --> Nov 2020 | Recruiting --> Terminated | Trial primary completion date: Apr 2021 --> Jul 2020; The study was terminated following an internal review of the company's research and development portfolio
- GSK3901961 / GSK
[VIRTUAL] CD8Α-ENHANCED NY-ESO-1-SPECIFIC TCR T CELLS (GSK3901961) IN HLA-A*02 PATIENTS WITH NSCLC: MASTER PROTOCOL SUBSTUDY 1 (ePoster Area) - Feb 4, 2021 - Abstract #EBMT2021EBMT_2503;
P1
Exploratory endpoints include laboratory parameters, overall survival, progression-free survival, disease control rate, time to response, and anti-GSK3901961 titers. The study is currently open and recruiting.