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Protocol No.1556GCCPrincipal InvestigatorHardy, Nancy
PhasePhase I
Age GroupAdult
TitleA Phase I Dose Escalation Open-Label Clinical Trial Evaluating the Safety and Efficacy of MAGE-A10c796T in Subjects with Stage IIIb or Stage IV Non-Small Cell Lung Cancer (NSCLC).
DescriptionThe changed T cells used in this study will be your own T cells that have been genetically changed. The aim of your genetically changed T-cells is to attack and destroy the cancer cells in your lungs. Getting genetically changed T cells is an experimental treatment. There are no T cell treatments for cancer approved by the Federal Food and Drug Administration (FDA) or sold on the market at this time. For the purposes of this research, the FDA is allowing the use of these genetically changed T-cells.
TreatmentGenetically Modified T-cells responding to MAGE-A10 positive tumor cells
Key Eligibility-Subject is >= 18 years of age on the day of signing informed consent.
-Histologically or cytologically confirmed diagnosis of advanced non-small cell lung cancer (stage IIIB or IV) or recurrent disease
-Subject has received or is receiving at least one line of prior therapy.
-Subject must be HLA-A*0201 or HLA-A*0206 positive, as per the protocol.
-Subject’s tumor (either an archival specimen or a fresh biopsy if archival tissue is unavailable) has been pathologically reviewed by an Adaptimmune designated central laboratory confirming MAGE A10 expression.
-ECOG Performance Status 0-1 and anticipated life expectancy > 3 months.
-All subjects must have normal left ventricular ejection fraction >=50%.
-Female subjects of childbearing potential (FPCP) must have a negative urine or serum pregnancy test.
-Male subjects must be surgically sterile or agrees to use a double barrier contraception method upon enrollment starting at the first dose of chemotherapy through at least 4 months after treatment.
-Subject must have adequate organ function as noted in the protocol
Applicable Disease SitesLung
Other Respiratory and Intrathoracic Organs
Therapies InvolvedChemotherapy (NOS)
Immunotherapy
Therapy (NOS)
Drugs InvolvedMAGE-A10^c796 T
MESNA
cyclophosphamide
fludarabine
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT02592577
ContactGreenebaum Comprehensive Cancer Center: Maha Khalil, PhD Phone:410-328-5009
Pager:
Email:mkhalil@umm.edu
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