Clinical trials: Neoantigens
Metastatic HPV-16 Positive Squamous Cell Anal Cancer
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated or Viral Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab
Background: A cancer treatment has been developed called "gene transfer" or "gene therapy." It involves taking white blood cells from a person (called apheresis), genetically modifying the cells in a lab to recognize cancer, and…
- Trial name
- NCT04536922
- Testing
- Cyclophosphamide, Fludarabine, Aldesleukin
- Where
- United States
- Sponsor
- National Cancer Institute (NCI)
Malignant Epithelial Neoplasms
Personalized TCR-T: Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T)
This is a phase I/Ib study of adoptively transferred T-cell receptor gene-engineered T cells (TCR-T) targeting tumor-specific antigens, with in vivo CD40 activation and PD-1 blockade, for patients with incurable cancers.
- Trial name
- NCT05349890
- Testing
- TCR-transduced T cells, CDX-1140, Pembrolizumab
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Providence Health & Services
Endocrine Tumors, Non-Small Cell Lung Cancer
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
Background: A person s tumor is studied for mutations. When cells are found that can attack the mutation in a person s tumor, the genes from those cells are studied to find the parts that make the attack possible.
- Conditions
- Endocrine Tumors, Non-Small Cell Lung Cancer, Ovarian Cancer, Breast Cancer
- Trial name
- NCT03412877
- Testing
- Cyclophosphamide, Fludarabine, Aldesleukin
- Where
- United States
- Volunteers
- 285 people
- Sponsor
- National Cancer Institute (NCI)
Lynch Syndrome
Preventive Dendritic Cell Vaccination for Lynch Syndrome Carriers
The primary objective is to assess the effect of vaccination with neopeptide-loaded dendritic cells on disease-free survival (DFS) compared to placebo in LS subjects who are known to be carrier of a germline MMR-gene mutation…
- Trial name
- PROTECT-Lynch (NCT07609901)
- Testing
- Arm A: DC vaccination
- Where
- Netherlands
- Volunteers
- 372 people
- Sponsor
- Radboud University Medical Center
Non-small Cell Lung Cancer
Durvalumab and Tremelimumab for Adjuvant Therapy of Resected NSCLC
Despite aggressive surgery and chemotherapy, the risk of lung cancer recurrence remains high in most patients. This study aims to determine if a novel immune therapy consisting of two drugs is feasible and potentially increases…
- Trial name
- NCT03130764
- Testing
- Durvalumab, Tremelimumab
- Sponsor
- Columbia University
Non-Small Cell Lung Cancer, Colorectal Cancer
A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens
The purpose of this study is to evaluate the dose, safety, immunogenicity and early clinical activity of GRT-C903 and GRT-R904, a neoantigen-based therapeutic cancer vaccine, in combination with immune checkpoint blockade, in…
- Conditions
- Non-Small Cell Lung Cancer, Colorectal Cancer, Pancreatic Cancer, Solid Tumor
- Trial name
- NCT03953235
- Testing
- GRT-C903, GRT-R904, nivolumab
- Where
- 12 sites in United States
- Volunteers
- 39 people
- Sponsor
- Gritstone bio, Inc.
Glioma, Malignant, Antigen-specific Vaccines
Neoantigens Phase I Trial in Newly Diagnosed Glioblastoma Patients
The primary objective of this study is to assess the safety and tolerability, feasibility of the NeoPep Vaccine in newly diagnosed glioblastoma (GB) patients.
- Conditions
- Glioma, Malignant, Antigen-specific Vaccines, Individualized Treatment
- Trial name
- NCT05557240
- Testing
- NeoPep Vaccine1 plus Poly-ICLC, NeoPep Vaccine2 plus Poly-ICLC
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Shanghai 10th People's Hospital
Endometrial Carcinoma, Endometrial Carcinoma Stage III
GYNORYLAQ™-VLINIVAL™: Ψ-Guided Personalized Neoantigen Peptide Vaccine for High-Risk Endometrial Cancer
GYNORYLAQ-VLINIVAL is an Early Phase I, non-randomized, single-arm, open-label clinical trial enrolling 40 patients with high-risk or recurrent endometrial carcinoma.
- Trial name
- GYNORYLAQ™ (NCT07316361)
- Testing
- • Biological: GYNORYLAQ-TM Personalized Neoantigenic Peptide Vaccine
- Where
- Greece
- Volunteers
- 40 people
- Sponsor
- Biogenea Pharmaceuticals Ltd.
Melanoma, Colon Cancer
Messenger RNA (mRNA)-Based, Personalized Cancer Vaccine Against Neoantigens Expressed by the Autologous Cancer
Background: Exome sequencing can identify certain gene mutations in a person's tumor. This can then be used to create cancer treatments.
- Conditions
- Melanoma, Colon Cancer, Gastrointestinal Cancer, Genitourinary Cancer
- Trial name
- NCT03480152
- Testing
- National Cancer Institute (NCI)-4650, a messenger ribonucleic acid (mRNA)-based, Personalized Cancer Vaccine
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- National Cancer Institute (NCI)
Non Small Cell Lung Cancer, Neoepitopes
AImmune - Artificial Intelligence Algorithm for Identification of Immunogenic Neoepitopes of Cancer to Predict and Boost Patient's Response to Immunotherapies.
The goal of the project is to develop and validate A.I.mmune technology. It performs complex analyses of patients' tumor and immune system state using data derived from next-generation sequencing of tumor and healthy tissue to…
- Conditions
- Non Small Cell Lung Cancer, Neoepitopes, Neoantigens, Immunotherapy
- Trial name
- NCT04145232
- Testing
- Collection of biopsy (FFPE), blood (PBMC) and stool
- Where
- Poland
- Volunteers
- 30 people
- Sponsor
- Ardigen
Biliary Malignant Tumors
Evaluation of the Safety, Tolerability and Efficacy of iNeo-Vac-R01, an Individualized mRNA Therapeutic Technology Based on Tumor Neoantigens, for Adjuvant Treatment in Patients With Biliary Malignant Tumors After Radical Resection
The primary objective of this study is to evaluate the safety of iNeo-Vac-R01, an individualized mRNA therapeutic technology based on tumor neoantigens, for the adjuvant treatment of patients with biliary malignant tumors after…
- Trial name
- NCT07368803
- Testing
- iNeo-Vac-R01
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Yifan Wang
Gastric Cancer, Neoantigens
Computational Prediction and Experimental Validation of Gastric Cancer Associated Neoantigens
This study is to develop methods for identification of neoantigens from patients with gastric cancer.
- Trial name
- NCT05498194
- Testing
- ratio of predicted neoantigens
- Where
- Vietnam
- Volunteers
- 50 people
- Sponsor
- University Medical Center Ho Chi Minh City (UMC)
Colonic Neoplasms, Colorectal Neoplasms
Study of an Individualized Vaccine Targeting Neoantigens in Combination With Immune Checkpoint Blockade for Patients With Colon Cancer
The primary objective is to assess and characterize the antitumor activity and safety and tolerability of adjuvant treatment with an individualized neoantigen vaccine called GRT-C901/GRT-R902 (chimpanzee adenovirus [ChAd] and…
- Trial name
- NCT05456165
- Testing
- GRT-C901, GRT-R902, Atezolizumab
- Where
- 3 sites in United States
- Sponsor
- Gritstone bio, Inc.
Lynch Syndrome
Preventive Dendritic Cell Vaccination for Lynch Syndrome
The aim of this study is to assess safety, immunogenicity and feasibility of vaccination with neopeptide-loaded dendritic cells in Lynch Syndrome subjects who are known to be carrier of a germline MMR-gene mutation without signs…
- Trial name
- PREVENT-Lynch (NCT07412197)
- Testing
- DC vaccination
- Where
- Netherlands
- Volunteers
- 16 people
- Sponsor
- Radboud University Medical Center
Colorectal Cancer
A First-In-Human Trial of pTTL in Advanced Colorectal Cancer
This is an open-label, non-randomised FIH trial investigating the safety and tolerability of a novel ATMP, pTTL, composed of autologous tumour-draining lymph node-derived T cells stimulated in vitro with personalised cancer…
- Trial name
- NCT05908643
- Testing
- pTTL
- Where
- 2 sites in Sweden
- Volunteers
- 16 people
- Sponsor
- Neogap Therapeutics AB
A Single Patient Will be Treated With Individual Patient TCR-Transduced PBL
A single patient will be treated with Individual Patient TCR-Transduced PBL
- Trial name
- NCT04194190
- Testing
- Individual Patient TCR-Transduced PBL
- Sponsor
- National Institutes of Health Clinical Center (CC)
Locally Recurrent Cancer, Metastatic Nasopharyngeal Cancer
Bevacizumab and Pembrolizumab Combination in Platinum-resistant Recurrent/Metastatic NPC
This is a single center, randomized, phase Ib/II open-label study of pembrolizumab (pembro or MK-3475) with or without bevacizumab in patients with recurrent non-curable or metastatic nasopharyngeal carcinoma (NPC).
- Trial name
- 2018/00947 (NCT03813394)
- Testing
- pembrolizumab, bevacizumab
- Where
- Singapore
- Volunteers
- 48 people
- Sponsor
- National University Hospital, Singapore
Myelodysplastic Syndromes
Personalized Adoptive Cellular Therapy Targeting MDS Stem Cell Neoantigens (PACTN)
This study will evaluate the safety of autologous T cells that have been immunized ex vivo with patient-specific MDS stem cell neoantigens in patients with MDS.
- Trial name
- NCT03258359
- Testing
- PACTN
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- PersImmune, Inc
Ovarian Cancer
Transcriptional Map of Ovarian Cancer at the Single Cell Level
In 2020, epithelial ovarian cancer (EOC) accounts for 313,959 new cases and 207,252 deaths worldwide. The standardized 5-year net survival of a woman with EOC is 44% for cases diagnosed between 2005-2010.
- Trial name
- Ova-seq (NCT05030805)
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Strasbourg, France
Primary/Relapsed Acute Lymphoblastic Leukemia (ALL) of Childhood, Adolescents and Young Adults
Patient-individualized Peptide Vaccination Based on Tumor-specific Mutations in Children and Young Adults With Primary/Relapsed ALL
The aim of this clinical study is to evaluate the feasibility and safety of an individualized peptide vaccination approach in patients with acute lymphoblastic leukemia (ALL).
- Trial name
- NCT03559413
- Testing
- Individual peptide vaccination with adjuvant GM-CSF and Imiquimod
- Where
- 5 sites in Germany
- Volunteers
- 30 people
- Sponsor
- University Children's Hospital Tuebingen