^
1m
Trial completion date • Metastases
|
HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
|
HLA-A*02:01 • HLA-A*02 • CTAG1B expression • HLA-A2 positive
|
cyclophosphamide • fludarabine IV • letetresgene autoleucel (GSK3377794)
1m
Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors (clinicaltrials.gov)
P1, N=22, Active, not recruiting, University Health Network, Toronto | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
Trial completion date • Trial primary completion date
|
HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
|
HLA-A*02 • CTAG1B expression
|
cyclophosphamide • fludarabine IV • mipetresgene autoleucel (TBI-1301)
2ms
PDC-LUNG-101: Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC (clinicaltrials.gov)
P1/2, N=73, Active, not recruiting, PDC*line Pharma SAS | Trial primary completion date: Dec 2025 --> Jul 2024
Trial primary completion date
|
CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A)
|
HLA-A*02
|
Keytruda (pembrolizumab) • pemetrexed • PDC*lung
3ms
Investigating the prognostic impact of NY-ESO-1 expression and HLA subtypes in metastatic synovial sarcoma. (PubMed, ESMO Open)
The primary tumor cohort showed no association between NY-ESO-1 expression and OS (including stratification by HLA-A∗02 subtype and treatment line), when adjusting for important prognostic factors, possibly due to small sample sizes.
Journal • Metastases
|
HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
3ms
Trial primary completion date
|
BRAF (B-raf proto-oncogene)
|
Libtayo (cemiplimab-rwlc) • BNT111
3ms
New P1 trial • Metastases
4ms
Administration of Donor Multi TAA-Specific T Cells for AML or MDS (ADSPAM) (clinicaltrials.gov)
P1, N=44, Recruiting, Baylor College of Medicine | Trial completion date: Feb 2026 --> Feb 2027 | Trial primary completion date: Apr 2024 --> Apr 2025
Trial completion date • Trial primary completion date
|
KIT (KIT proto-oncogene, receptor tyrosine kinase) • WT1 (WT1 Transcription Factor) • CD33 (CD33 Molecule) • ANPEP (Alanyl Aminopeptidase, Membrane)
|
MultiTAA T cell therapy
4ms
TACTIC - TAA Specific Cytotoxic T Lymphocytes in Patients With Breast Cancer (clinicaltrials.gov)
P2, N=12, Active, not recruiting, Baylor College of Medicine | Trial completion date: May 2024 --> May 2025
Trial completion date
|
MultiTAA T cell therapy
5ms
Automated immunoassay of serum NY-ESO-1 and XAGE1 antibodies for predicting clinical benefit with immune checkpoint inhibitor (ICI) in advanced non-small cell lung cancer. (PubMed, Cancer Treat Res Commun)
Our immunoassay of NY-ESO-1/XAGE1 Abs is probably useful for predicting the clinical benefit with nivolumab in NSCLC, including those harboring driver genes. These results suggest that our immunoassay may be useful in ICI monotherapy for NSCLC.
Journal • Checkpoint inhibition • Metastases
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • CTAG1B (Cancer/testis antigen 1B)
|
Opdivo (nivolumab)
5ms
Trial suspension • Metastases
|
HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B) • SSX1 (SSX Family Member 1)
|
cyclophosphamide • fludarabine IV
5ms
Expression of the tumor antigens NY-ESO-1, tyrosinase, MAGE-A3, and TPTE in pediatric and adult melanoma: a retrospective case control study. (PubMed, Virchows Arch)
BNT111, an investigational lipoplex-formulated mRNA-based therapeutic cancer vaccine encoding melanoma TAAs NY-ESO-1, tyrosinase, MAGE-A3, and TPTE, is undergoing clinical testing in adults. All four TAAs were expressed in pediatric melanoma, albeit NY-ESO-1 and MAGE-A3 to a lesser extent than in adult melanoma. These data support the possibility of investigating vaccines targeting these TAAs for the treatment of pediatric melanoma.
Retrospective data • Journal • IO biomarker
|
CTAG1B (Cancer/testis antigen 1B)
|
BNT111
6ms
Enrollment change
6ms
A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer (clinicaltrials.gov)
P1, N=20, Not yet recruiting, University of Southern California | Trial completion date: Apr 2027 --> Aug 2027 | Initiation date: Apr 2024 --> Aug 2024 | Trial primary completion date: Apr 2026 --> Aug 2026
Trial completion date • Trial initiation date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CTAG1B (Cancer/testis antigen 1B)
|
cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • NY-ESO-1 TCR
6ms
Enrollment open • Metastases
|
HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B) • SSX1 (SSX Family Member 1)
|
HLA-A*02
|
cyclophosphamide • fludarabine IV
7ms
ZENYTH-ESO: Master Protocol to Assess Safety and Dose of First Time in Human Next Generation Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Advanced Solid Tumors (clinicaltrials.gov)
P1, N=12, Terminated, GlaxoSmithKline | Trial completion date: Dec 2025 --> Jun 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Jun 2023; The study was terminated due to a change in GSK's R&D priorities.
Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B) • CTAG2 (Cancer/testis antigen 2)
|
HLA-A*02:01 • HLA-A*02 • HLA-A2 positive • CTAG2 expression
|
cyclophosphamide • fludarabine IV • GSK3845097 • GSK3901961 • LYL132
7ms
T Cell Receptor-Directed Bispecific T Cell Engager Targeting MHC-Linked NY-ESO-1 for Tumor Immunotherapy. (PubMed, Biomedicines)
We also found that the in vitro activity of IgG-T-TCE-NY could be leveraged by various anti-CD3 antibodies and Fc silencing. The IgG-T-TCE-NY efficiently inhibited tumor growth in a tumor-PBMC co-engrafted mouse model without any obvious toxicities.
Journal • IO biomarker
|
HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
|
HLA-A*02
7ms
Trial primary completion date • Combination therapy
|
HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
|
HLA-A*02:01 • HLA-A*02 • CTAG1B expression • HLA-A2 positive
|
cyclophosphamide • fludarabine IV • letetresgene autoleucel (GSK3377794)
7ms
NY-ESO-1 TCR-T Cells for NY-ESO-1 Positive Subjects With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=18, Recruiting, TCRCure Biopharma Ltd. | Phase classification: P1/2 --> P1 | Trial primary completion date: Oct 2023 --> Oct 2024
Phase classification • Trial primary completion date • Metastases
|
CTAG1B (Cancer/testis antigen 1B)
|
CTAG1B expression
|
albumin-bound paclitaxel • cyclophosphamide • fludarabine IV • N201
8ms
PRECIOUS-01: Dose Escalation Study of Immunomodulatory Nanoparticles (clinicaltrials.gov)
P1, N=15, Recruiting, Radboud University Medical Center | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date • Immunomodulating
|
CD20 (Membrane Spanning 4-Domains A1) • CD8 (cluster of differentiation 8) • CTAG1B (Cancer/testis antigen 1B) • FOXP3 (Forkhead Box P3)
|
CD20 positive
|
PORT-3
8ms
Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
P1/2, N=75, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
Trial completion date • Trial primary completion date • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CTAG1B (Cancer/testis antigen 1B)
|
PD-L1 expression • CTAG1B expression
|
Tecentriq (atezolizumab) • Hiltonol (poly-ICLC) • guadecitabine (SGI-110) • rasdegafusp alfa (CDX-1401)
8ms
Phase I/Ib Study of NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Against the NY-ESO-1 (clinicaltrials.gov)
P1, N=44, Suspended, M.D. Anderson Cancer Center | Not yet recruiting --> Suspended
Trial suspension • Metastases
|
HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B) • SSX1 (SSX Family Member 1)
|
HLA-A*02
|
cyclophosphamide • fludarabine IV
9ms
Serum NY-ESO-1 and p53 antibodies as useful tumor markers in gastric cancer. (PubMed, Ann Gastroenterol Surg)
The combination of NY-ESO-1 and p53 antibody responses to CEA and CA19-9 increases the diagnostic accuracy of gastric cancer. Serum NY-ESO-1 and p53 antibodies may be useful tumor markers for gastric cancer.
Journal
|
CEACAM5 (CEA Cell Adhesion Molecule 5) • CTAG1B (Cancer/testis antigen 1B) • CA 19-9 (Cancer antigen 19-9)
9ms
Fusion of NY-ESO-1 epitope with heat shock protein 70 enhances its induced immune responses and antitumor activity against glioma in vitro. (PubMed, Transl Cancer Res)
These findings indicate that the HSP70/NY-ESO-1 p86-94 may significantly enhance CTLs-mediated cytotoxicity and targeting ability against NY-ESO-1-expressing tumors in vitro. 5-Aza-CdR treatment with HSP70 binding to tumor antigen is a new strategy for immunotherapy of the tumors with poor CTA expression.
Preclinical • Journal • IO biomarker
|
CTAG1B (Cancer/testis antigen 1B)
|
CTAG1B expression
9ms
Phase classification • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1) • HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B) • CTAG2 (Cancer/testis antigen 2)
|
HLA-A*02
|
Keytruda (pembrolizumab) • letetresgene autoleucel (GSK3377794)
9ms
A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer (clinicaltrials.gov)
P1, N=20, Not yet recruiting, University of Southern California | Trial completion date: Nov 2026 --> Apr 2027 | Initiation date: Nov 2023 --> Apr 2024 | Trial primary completion date: Nov 2025 --> Apr 2026
Trial completion date • Trial initiation date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CTAG1B (Cancer/testis antigen 1B)
|
HER-2 negative • PGR negative
|
cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • NY-ESO-1 TCR
10ms
NY-ESO-1-specific T cell receptor-engineered T cells and Tranilast, a TRPV2 antagonist bivalent treatment enhances the killing of esophageal cancer: a dual-targeted cancer therapeutic route. (PubMed, Cancer Cell Int)
Our findings suggest that dual-targeted immunotherapy may have a superior antitumor effect. Our study presents a technique to evolve novel, robust, timely therapeutic strategies and interventions for EC and other malignancies.
Journal • IO biomarker
|
HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B) • TRPV2 (Transient Receptor Potential Cation Channel Subfamily V Member 2)
|
HLA-A*02
10ms
Observational data • Journal
|
CTAG1B (Cancer/testis antigen 1B)
10ms
EGFR, HLA-G, CD70, c-MET, and NY-ESO1 as potential biomarkers in high grade epithelial ovarian carcinoma. (PubMed, Cancer Biomark)
C-MET and NY-ESO1 do not have any clinical correlations. EGFR can potentially serve as target in future clinical immune therapy trials.
Journal
|
EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase) • CTAG1B (Cancer/testis antigen 1B) • CD70 (CD70 Molecule) • HLA-G (Major Histocompatibility Complex, Class I, G)
|
EGFR expression • EGFR positive
11ms
The role of the NY-ESO-1 in the prognosis of gastric cancer. (PubMed, Biomol Biomed)
No significant difference in NY-ESO-1 expression in primary tumors was observed concerning lymph node metastasis status. In summary, our findings suggest that increased expression of NY-ESO-1 could potentially serve as a prognostic biomarker for gastric cancer.
Journal
|
CTAG1B (Cancer/testis antigen 1B)
|
CTAG1B expression
12ms
Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors (clinicaltrials.gov)
P1, N=22, Active, not recruiting, University Health Network, Toronto | Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Sep 2023 --> Sep 2024
Trial completion date • Trial primary completion date
|
HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
|
HLA-A*02 • CTAG1B expression
|
cyclophosphamide • fludarabine IV • mipetresgene autoleucel (TBI-1301)
12ms
Trial completion
|
HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
|
HLA-A*02 • CTAG1B expression
|
cyclophosphamide • mipetresgene autoleucel (TBI-1301)
12ms
Phase I/II Randomized Trial of Cord Blood-derived NK Cells Genetically Engineered With NY-ESO-1 TCR/IL-15 Cell Receptor for Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
P1/2, N=44, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting | Initiation date: May 2024 --> Nov 2023
Enrollment open • Trial initiation date
|
HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
|
HLA-A*02:01 • HLA-A*02
|
cyclophosphamide • fludarabine IV
12ms
NY-ESO-1 antigen-antibody interaction process based on an TFBG plasmonic sensor. (PubMed, Biomed Opt Express)
Furthermore, experimental results have also demonstrated the repeatability of the proposed biosensor. This proposed biosensor features label-free, compactness, and fast response, which could be potentially applied in the diagnosis of esophageal cancer.
Journal
|
CTAG1B (Cancer/testis antigen 1B)
1year
Novel hypomethylating agent GSK-3484862 sensitizes glioblastoma to NY-ESO-1 specific immunotherapy (SNO 2023)
Previous work from our group has shown that Decitabine (DAC), a demethylating agent, can improve the immunogenicity of Glioblastoma (GBM) for immuno-therapeutic targeting through the upregulation of immunogenic cancer testis antigens (CTA) such as NY-ESO-1 and altered expression of other immunoregulatory programs... Our results demonstrate a preclinical rationale for the use of GSK as a viable pro-antigenic agent for the sensitization of GBM to targeted immune therapy.
IO biomarker
|
CTAG1B (Cancer/testis antigen 1B)
|
CTAG1B expression
|
decitabine
1year
Decitabine primes Glioblastoma to NY-ESO-1 specific T-cell cytolysis via DNA demethylation of NY-ESO-1, cancer-testis antigens, and pro-inflammatory signatures (SNO 2023)
Hypomethylating agents like DAC upregulate immunogenic signatures in primary and immortalized GBM cells, rendering them susceptible to antigen specific T-cell targeting. These pleiotropic effects demonstrate strong preclinical rationale for use of DAC to sensitize GBM for targeting by immune therapies.
IO biomarker • Epigenetic controller
|
CTAG1B (Cancer/testis antigen 1B)
|
CTAG1B expression
|
decitabine
1year
A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer (clinicaltrials.gov)
P1, N=20, Not yet recruiting, University of Southern California | Trial completion date: Apr 2026 --> Nov 2026
Trial completion date • IO biomarker • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • PD-1 (Programmed cell death 1) • CTAG1B (Cancer/testis antigen 1B) • CD4 (CD4 Molecule)
|
HER-2 negative • PD-1 expression • PGR negative
|
cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • NY-ESO-1 TCR
1year
Checkpoint Immunotherapy Is Associated with Preferential Activation of Tumor-Antigen Specific CD4+ T Cells in MDS (ASH 2023)
Background: Patients with intermediate and higher-risk MDS are generally treated with the DNA hypomethylating agents (HMAs) azacytidine and decitabine...This open-label, non-randomized single center Phase 1 study used an HLA unrestricted NY-ESO-1 vaccine (CDX-1401 (1 mg) + poly-ICLC (1.8 mg)) in combination with standard dose decitabine (20mg/m2/d x 5 days) and nivolumab (3 mg/kg every 2 weeks), 4 cycles of combination therapy were planned on study; patients deriving clinical benefit could continue treatment at the discretion of the treating physician... These results suggest that the use of immunotherapy to induce effective, cytotoxic anti-tumor T cell responses depends upon the myeloid immunologic milieu in MDS patients. The critical importance of cDC1 function has recently been described and appreciated in the context of solid tumor immunotherapy. The observation of both numerical and functional defects of this cell population in patients with myeloid neoplasia provides a possible explanation for the disappointing efficacy of immunotherapies in this disease state.
PD(L)-1 Biomarker • IO biomarker
|
CD8 (cluster of differentiation 8) • CTAG1B (Cancer/testis antigen 1B) • CD4 (CD4 Molecule)
|
Opdivo (nivolumab) • azacitidine • decitabine • Hiltonol (poly-ICLC) • rasdegafusp alfa (CDX-1401)
1year
TCR-Engineered Lymphocytes Targeting NY-ESO-1: In Vitro Assessment of Cytotoxicity against Tumors. (PubMed, Biomedicines)
Our findings underscore the specific targeting potential of engineered TCR T cells against NY-ESO-1-positive tumors. Further comprehensive in vivo investigations are essential to thoroughly validate these results and effectively harness the intrinsic potential of genetically engineered T cells for combating cancer.
Preclinical • Journal • IO biomarker
|
IFNG (Interferon, gamma) • CTAG1B (Cancer/testis antigen 1B) • FASLG (Fas ligand) • FAS (Fas cell surface death receptor)
1year
PDC-LUNG-101: Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC (clinicaltrials.gov)
P1/2, N=73, Active, not recruiting, PDC*line Pharma SAS | Recruiting --> Active, not recruiting | Trial completion date: Sep 2025 --> Dec 2025 | Trial primary completion date: Sep 2025 --> Dec 2025
Enrollment closed • Trial completion date • Trial primary completion date
|
CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A)
|
HLA-A*02
|
Keytruda (pembrolizumab) • pemetrexed • PDC*lung
1year
Gene of the month: cancer testis antigen gene 1b (NY-ESO-1). (PubMed, J Clin Pathol)
From cancer vaccines to engineered cellular therapy approaches, a multitude of immunotherapies targeting CTA's are coming to the forefront of oncology. Although the efficacy of such approaches have yet to provide convincing evidence of durable response, early phase clinical trial data has resulted in some exciting findings which will have significant potential to act as a platform for future practice changing technologies.
Journal • IO biomarker
|
CTAG1B (Cancer/testis antigen 1B)
1year
New P1 trial • Metastases
|
HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B) • SSX1 (SSX Family Member 1)
|
HLA-A*02
|
cyclophosphamide • fludarabine IV
1year
Safety and Efficacy of NY-ESO-1 Antigen-specific T-cell Receptor Gene-Transduced T Lymphocytes in Patients with Synovial Sarcoma: A Phase I/II Clinical Trial. (PubMed, Clin Cancer Res)
Adoptive immunotherapy with TBI-1301 to selectively target NY-ESO-1 positive tumor cells appears to be a promising strategy for the treatment of advanced or recurrent synovial sarcoma with acceptable toxicity.
P1/2 data • Journal • IO biomarker
|
HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
|
HLA-A*02 • CTAG1B expression
|
cyclophosphamide • mipetresgene autoleucel (TBI-1301)