Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Melanoma

Head and Neck Neoplasms

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Transitional Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

Infusion of autologous genetically modified MAGE A10ᶜ⁷⁹⁶T on Day 1

Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells

David Hong, MD

This Phase 1 study is designed as a cell dose escalation trial in HLA-A\*02:01 and HLA-A\*02:06 subjects with MAGE-A10 positive urothelial, melanoma or head and neck tumors. The study will enroll subjects between the ages of 18 and 75 using a modified 3+3 cell dose escalation design, to evaluate dose limiting toxicities and determine the target cell dose range. Following the dose escalation phase, additional subjects will be enrolled at the target cell dose range to further characterize safety and the effects at this cell dose.

The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells. When the MAGE-A10ᶜ⁷⁹⁶T cells are available, subjects will undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by T cell infusion. The purpose of this study is to test the safety of genetically changed T cells and find out what effects, if any, they have in subjects with urothelial, melanoma or head and neck cancer.

Subjects will be seen frequently by the Study Physician after receiving their T cells for the next 6 months. After that, subjects will be seen every 3, 6, or 12 months according to the Schedule of Procedures. All subjects completing or withdrawing from the interventional portion of the study will enter a long term follow-up phase for observation of delayed adverse events and overall survival for 15 years post-infusion.

MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers

Phase 1 Cell Dose Escalation Study to Assess the Safety and Tolerability of Genetically Engineered MAGE-A10ᶜ⁷⁹⁶T in HLA-A2+ Subjects With MAGE-A10 Positive Urothelial, Melanoma or Head and Neck Tumors

Determine if treatment with autologous genetically modified T cells, (MAGE A10ᶜ⁷⁹⁶T ) is safe and tolerable through laboratory assessments including chemistry, hematology and coagulation; and cardiac assessments, including ECG/troponin.

Evaluation of the persistence of the infused T cells in the periphery.

Evaluation of RCL in Subject PBMCs using PCR-based assay.

Evaluation of dose limiting toxicities will be performed using the CTCAE Version 4.0

Evaluation of the efficacy of the treatment by assessment of the Overall Response Rate according to RECIST v1.1

Evaluation of the efficacy of the treatment by assessment of time to first response.

Evaluation of the efficacy of the treatment by assessment of duration of response.

Evaluation of the efficacy of the treatment by assessment of duration of stable disease.

Evaluation of the efficacy of the treatment by assessment of progression-free survival.

Evaluation of the efficacy of the treatment by assessment of overall survival.

* New occurrence of any malignancy
* New occurrence or exacerbation of a pre-existing neurologic disorder
* New occurrence or exacerbation of a prior rheumatologic or other autoimmune disorder
* New occurrence of a hematologic disorder
* New occurrence of any opportunistic and/or serious infections
* New occurrence of any unanticipated illness and/or hospitalization deemed related to gene modified cell therapy

Adaptimmune

Digestive System Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Calcium Carbonate

Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1

Autologous genetically modified ADP-A2M4CD8 cells

This study will investigate the efficacy of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumor antigen status and whose esophageal or esophagogastric junction (EGJ) cancer expresses the MAGE-A4 protein.

ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)

A Phase 2 Open-Label Clinical Trial of ADP-A2M4CD8 in Subjects With Advanced Esophageal or Esophagogastric Junction Cancers

ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1

Determine if treatment with ADP-A2M4CD8 is safe and tolerable through assessment of adverse events (AEs) including Serious Adverse Events (SAEs)

Best Overall Response (BOR) is per RECIST V1.1.

For patients who are observed to respond to ADP-A2M4CD8, the time taken from date of infusion to achieve a partial response or complete response (TTR) is assessed.

For patients who are observed to respond to ADP-A2M4CD8, the DoR is the date of initial response (including confirmation) from date of infusion up until disease progression per RECIST v 1.1 or death.

PFS is assessed from date of infusion of ADP-A2M4CD8 up until the date of disease progression per RECIST v1.1 or death.

OS is assessed from date of infusion of ADP-A2M4CD8 up until the date of patient death.

Development and validation of the MAGE-A4 antigen expression companion diagnostic assay

Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by flow cytometry

ICON plc

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endometrial Neoplasms

Stomach Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Neoplasms

Uterine Diseases

Stomach Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Stomach Cancer

Antineoplastic Agents

Nivolumab

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1 alone or in combination with either nivolumab 480 mg IV every four weeks or pembrolizumab 400mg IV every 6 weeks

Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks

Sajeve S Thomas, MD

Donald P Lawrence

Donald Lawrence, MD

Rebecca Munsch

Brian Van Tine, MD

David Aggen, MD

Alex Guess

Jeffrey M Clarke, MD

Silas Day

Adam Asch

Nurse Navigators

Melissa L Johnson, MD

Jessica Neumann

John A Charlson, MD

Genevieve Mendiola

Marcus Butler, MD

Concha Hernandez

Jon Zugazagoitia Fraile, MD

Mariano Ponz-Sarvisé, MD PhD

Mariano Ponz-Sarvisé, MD

Inma Blasco

Andres Cervantes Ruiperez, MD

Elena G Cabanas, MD

Victor Moreno, MD

Esther Ordoñez

Emiliano Calvo Aller, MD

Esperanza Muñoz

Reyes Bernabe Caro, MD

This study will investigate the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and MAGE-A4 tumor antigen. Tumor indications include endometrial, esophageal, esophagogastric junction (EGJ), gastric, head and neck, melanoma, non-small cell lung (NSCLC), ovarian or urothelial cancer.

Conditions:

Endometrial Esophageal Cancer Esophagogastric Junction (EGJ) Gastric (stomach) Head and Neck Melanoma Non-small Cell Lung (NSCLC) Ovarian Cancer

ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)

A Phase 1 Dose Escalation Study To Assess Safety And Efficacy Of ADP-A2M4CD8 As Monotherapy Or In Combination With Either Nivolumab Or Pembrolizumab In HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)

Determination of incidence of dose-limiting toxicities, adverse events and tolerable dose

Incidence of patients with Replication-competent Retrovirus, persistence of ADP-A2M4CD8 T-cells and incidence of insertional oncogenesis.

For patients who are observed to respond to ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab, the time taken to achieve a partial response or complete response (TTR) is assessed.

For patients who are observed to respond to ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab, the DOR is the date of first response (including confirmation) up until disease progression per RECIST v 1.1 or death

For patients who are observed to have stable disease by RECIST v 1.1, the duration of period of stable disease until disease progression or death

PFS is assessed from date of infusion of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab up until the date of disease progression per RECIST v1.1 or death.

OS is assessed from date of infusion of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab up until the date of patient death.

Carcinoma, Hepatocellular

Liver Neoplasms

Liver Diseases

Adenocarcinoma

Infusion of autologous genetically modified AFPᶜ³³²T cells

Autologous genetically modified AFPᶜ³³²T cells

Richard S Finn, MD

This first time in human study is intended for men and women between 18 and 75 years of age who have advanced liver cancer which has grown or returned after being treated or another AFP expressing tumor. Those who did not tolerate or refused other therapies may also participate. The purpose of this study is to test the safety of genetically changed T cells that target alpha-fetoprotein (AFP) and find out what effects, if any, they have in subjects with liver cancer or other AFP expressing tumor types. This study is for subjects who have a blood test positive for appropriate HLA-A\*02 P Group and have adequate AFP protein in blood or tumor, and whose noncancerous liver tissue has very little AFP protein (Liver only).

The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells.

The manufacturing of T cells takes about 1 month to complete. The T cells will be given back to the subject through an intravenous infusion after 3 days of chemotherapy. The study will evaluate three different cell dose levels in order to find out the target cell dose. Once the target cell dose is determined, additional subjects will be enrolled to further test the safety and effects at this cell dose.

Subjects will be hospitalized for at least 1 week after receiving their T cells back and then seen frequently by the Study Physician for the next 6 months. After that, subjects will be seen every three months. If subjects have disease progression or withdraw from the study, they will then be entered into a long-term follow up for safety monitoring. In long-term follow up, subjects will be seen every 6 months by their Study Physician for the first 5 years after the T cell infusion and annually for the next 10 years.

AFPᶜ³³²T in Advanced HCC

A Phase I Open Label Clinical Trial Evaluating the Safety and Anti-Tumor Activity of Autologous T Cells Expressing Enhanced TCRs Specific for Alpha Fetoprotein (AFPᶜ³³²T) in HLA-A2 Positive Subjects With Advanced Hepatocellular Carcinoma (HCC) or Other AFP Expressing Tumor Types

Determine if treatment with autologous genetically modified T cells, (AFPᶜ³³²T) is safe and tolerable through assessment of DLTs, AEs, including SAEs; laboratory assessments including chemistry, hematology, coagulation, cardiac assessments including ECG, and cardiac Troponin

Evaluation of the efficacy of the treatment by assessment of time to first response

Evaluation of the efficacy of the treatment by assessment of duration of response

Evaluation of the efficacy of the treatment by assessment of duration of stable disease

Evaluation of the efficacy of the treatment by assessment of progression-free survival

Evaluation of the efficacy of the treatment by assessment of overall survival

Blood and Lymph Conditions

Hematologic Neoplasms

Hematologic Diseases

Long term follow-up of subjects with solid or hematological malignancies who have received lentivirus-mediated genetically engineered T Cell Receptors in a previous trial

No study drug is administered in this study. Subjects who received lentivirus-mediated genetically engineered T Cell Receptors in a previous trial will be evaluated in this trial for long-term safety and efficacy.

Genetically engineered T Cell Receptors

Subjects who previously took part in an Adaptimmune study and received genetically changed T cells (including but not limited to MAGE-A10ᶜ⁷⁹⁶T and MAGE-A4ᶜ¹º³²T) are asked to take part in this long term follow-up study. Subjects will be asked to join this study once they complete the parent interventional study.

The purpose of this study is to find out if the genetically changed T cells that subjects received in the parent study have any long-term side effects. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.

For a period of 15 years starting from last administration of the genetically changed T cells, subjects will visit their study doctor for a check-up and to have blood tests to look for any changes that might have happened because of the genetically changed T cells.

This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have received lentivirus-mediated genetically engineered T Cell Receptors in an Adaptimmune sponsored clinical trial. The study is designed in accordance with FDA and EMA guidance on gene therapy trials.

The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in Adaptimmune clinical studies. The study will include subjects who have received various T cell receptors including but not limited to MAGE-A10ᶜ⁷⁹⁶T and MAGE-A4ᶜ¹º³²T. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.

Long Term Follow up of Subjects Exposed to Genetically Engineered T Cell Receptors

Long Term Follow-up of Subjects Exposed to Genetically Engineered Tumor Antigen Specific T Cell Receptors

* New malignancies
* New incidence or exacerbation of a pre-existing neurologic disorder
* New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder
* New incidence of a hematologic disorder
* Opportunistic and/or serious infections
* Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy

Subjects' peripheral blood samples will be used to evaluate RCL

Peripheral blood samples will be used to evaluate persistence

Number of samples positive for vector integration by PCR

OS defined as the interval between the date of first T cell infusion and date of death due to any cause

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Urinary Bladder Neoplasms

Sarcoma

Liposarcoma

Sarcoma, Synovial

Liposarcoma, Myxoid

Neoplasms, Connective and Soft Tissue

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Neoplasms, Adipose Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Synovial Sarcoma

Myxoid Liposarcoma

Infusion of autologous genetically modified MAGE-A4ᶜ¹º³²T on Day 1

Autologous genetically modified MAGE-A4ᶜ¹º³²T cells

Up to 10 subjects will be considered for Radiation sub-study. Radiation with an intensity of 1.4Gy for 5 days before infusion of MAGE-A4c1032T cells

Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation

This study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in subjects who have the appropriate HLA-A2 tissue marker and whose urinary bladder, melanoma, head and neck, ovarian, non-small cell lung, esophageal, gastric, synovial sarcoma, or myxoid/round call liposarcoma (MRCLS) tumor has the MAGE-A4 protein expressed. This study will take a subject's T cells and give them a T cell receptor protein that recognizes and attacks the tumors. This study has a substudy component that will investigate the safety and tolerability of MAGE-A4c1032T cell therapy in combination with low dose radiation in up to 10 subjects.

MAGE-A4ᶜ¹º³²T for Multi-Tumor

Phase 1 Dose Escalation, Multi-tumor Study to Assess the Safety, Tolerability and Antitumor Activity of Genetically Engineered MAGE-A4ᶜ¹º³²T in HLA-A2+ Subjects With MAGE-A4 Positive Tumors

Evaluation of post-infusion T-cell trafficking in irradiated vs non-irradiation lesions

Determine if treatment with autologous genetically modified T cells (MAGE-A4ᶜ¹º³²T) is safe and tolerable through laboratory assessments including chemistry, hematology and coagulation.

Evaluate DLTs and toxicity assessment using NCI CTCAE.

Evaluation of persistence of genetically modified T cells in the periphery.

Evaluation of RCL in subject PBMCs using PCR-based assay.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers	NCT02989064	Urothelial Carc... Head and Neck C... Melanoma Bladder Urothel...	Autologous gene...	18 Years - 75 Years	Adaptimmune
ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)	NCT04752358	Esophageal Canc... Esophagogastric...	Autologous gene...	18 Years - 75 Years	Adaptimmune
ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)	NCT04044859	Endometrial Can... Esophageal Canc... Esophagogastric... Gastric (Stomac... Head and Neck C... Melanoma Ovarian Cancer Non-small Cell ... Urothelial Canc...	Autologous gene...	18 Years - 75 Years	Adaptimmune
AFPᶜ³³²T in Advanced HCC	NCT03132792	Hepatocellular ... AFP Expressing ...	Autologous gene...	18 Years - 75 Years	Adaptimmune
AFPᶜ³³²T in Advanced HCC	NCT03132792	Hepatocellular ... AFP Expressing ...	Autologous gene...	18 Years - 75 Years	Adaptimmune
Long Term Follow up of Subjects Exposed to Genetically Engineered T Cell Receptors	NCT03391791	Solid and Hemat...	Genetically eng...	18 Years -	Adaptimmune
MAGE-A4ᶜ¹º³²T for Multi-Tumor	NCT03132922	Urinary Bladder... Melanoma Head and Neck C... Ovarian Cancer Non-Small Cell ... Esophageal Canc... Gastric Cancer Synovial Sarcom... Myxoid Round Ce... Gastroesophagea...	Autologous gene... Autologous gene...	18 Years - 75 Years	Adaptimmune
Long Term Follow up of Subjects Exposed to Genetically Engineered T Cell Receptors	NCT03391791	Solid and Hemat...	Genetically eng...	18 Years -	Adaptimmune
MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers	NCT02989064	Urothelial Carc... Head and Neck C... Melanoma Bladder Urothel...	Autologous gene...	18 Years - 75 Years	Adaptimmune
MAGE-A4ᶜ¹º³²T for Multi-Tumor	NCT03132922	Urinary Bladder... Melanoma Head and Neck C... Ovarian Cancer Non-Small Cell ... Esophageal Canc... Gastric Cancer Synovial Sarcom... Myxoid Round Ce... Gastroesophagea...	Autologous gene... Autologous gene...	18 Years - 75 Years	Adaptimmune
ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)	NCT04752358	Esophageal Canc... Esophagogastric...	Autologous gene...	18 Years - 75 Years	Adaptimmune

Spots Global Cancer Trial Database for spear t cell

Every month we try and update this database with for spear t cell cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.