Letetresgene Autoleucel Engineered T Cells in NY-ESO-1 Positive Participants With Advanced Myxoid/ Round Cell Liposarcoma
NCT ID: NCT02992743
Last Updated: 2023-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
23 participants
INTERVENTIONAL
2016-12-06
2022-03-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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letetresgene autoleucel (GSK3377794)
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive letetresgene autoleucel (GSK3377794), as a single intravenous (IV) infusion after completing lymphodepleting chemotherapy.
letetresgene autoleucel (GSK3377794)
Letetresgene autoleucel (GSK3377794) as an IV infusion.
Cyclophosphamide
Cyclophosphamide will be used as a lymphodepleting chemotherapy.
Fludarabine
Fludarabine will be used as a lymphodepleting chemotherapy.
Interventions
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letetresgene autoleucel (GSK3377794)
Letetresgene autoleucel (GSK3377794) as an IV infusion.
Cyclophosphamide
Cyclophosphamide will be used as a lymphodepleting chemotherapy.
Fludarabine
Fludarabine will be used as a lymphodepleting chemotherapy.
Eligibility Criteria
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Inclusion Criteria
* Participant has a diagnosis of advanced (metastatic or inoperable) high grade myxoid liposarcoma / myxoid round cell liposarcoma confirmed histologically and by the presence of the reciprocal chromosomal translocation t(12;16) (q13;p11) or t(12; 22) (q13;q12).
* Participant has measurable disease according to RECIST v1.1 criteria.
* Participant must have previously received or be intolerant to anthracycline based therapy for advanced (metastatic or inoperable) disease.
* Participants who received neoadjuvant/adjuvant anthracycline based therapy and progressed within 6 months of completion of therapy will be eligible.
* Participant must be HLA A\*02:01, HLA A\*02:05 and/or HLA-A\*02:06 positive.
* Participant's tumor (either the most recent archival specimen or a fresh biopsy) is positive for NY-ESO-1 expression by a designated central laboratory.
* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
* Participant has a left ventricular ejection fraction \>=45%.
* Participant is fit for apheresis and has adequate venous access for the cell collection.
* Participants must satisfy pregnancy and contraceptive requirements per protocol and have adequate organ function per protocol specified values.
Exclusion Criteria
* Any previous allogeneic hematopoietic stem cell transplant.
* Participant has history of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study.
* Participant has history of chronic or recurrent (within the last year prior to screening) severe autoimmune or immune mediated disease requiring steroids or other immunosuppressive treatments.
* Participant has known active brain or leptomeningeal metastases.
* Participant has other prior malignancy that is not in complete remission.
* Participant has uncontrolled intercurrent illness including, but not limited to:
* (i) Ongoing or active infection.
* (ii) Clinically significant cardiac disease
* (iii) Interstitial lung disease (participants with existing pneumonitis as a result of radiation are not excluded, however, participants must not be oxygen dependent).
* Participant has active infection with Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV), ), Hepatitis C virus (HCV) or human T-lymphotropic virus (HTLV).
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Ann Arbor, Michigan, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Columbus, Ohio, United States
GSK Investigational Site
Houston, Texas, United States
Countries
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References
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D'Angelo SP, Druta M, Van Tine BA, Liebner D, Schuetze SM, Tap WD, Preston J, Goodison S, D'Souza JW, Kapoor GS, Suchindran S, Zajic S, Bhaskar A, Kaczynski H, Kim J, Klohe E, Corigliano E, Eleftheriadou I, Nathenson MJ, Somaiah N. Letetresgene Autoleucel in Advanced/Metastatic Myxoid/Round Cell Liposarcoma. J Clin Oncol. 2025 May 20;43(15):1777-1788. doi: 10.1200/JCO-24-01466. Epub 2025 Jan 21.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ADP-0011-007
Identifier Type: OTHER
Identifier Source: secondary_id
208469
Identifier Type: -
Identifier Source: org_study_id
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