Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Adenocarcinoma

Stomach Neoplasms

Esophageal Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Melanoma

Head and Neck Neoplasms

Sarcoma

Liposarcoma

Sarcoma, Synovial

Liposarcoma, Myxoid

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urogenital Neoplasms

Neoplasms, Connective and Soft Tissue

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Esophageal Diseases

Neoplasms, Adipose Tissue

Neoplasms, Connective Tissue

Stomach Cancer

Esophageal Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Synovial Sarcoma

Myxoid Liposarcoma

Neuroendocrine Tumor

Neuroepithelioma

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

David Hong, MD

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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
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

Spots Global Cancer Trial Database for myxoid round cell liposarcoma