Letetresgene Autoleucel Engineered T Cells in NY-ESO-1 Positive Participants With Advanced Myxoid/ Round Cell Liposarcoma
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ClinicalTrials.gov Identifier: NCT02992743 |
Recruitment Status :
Completed
First Posted : December 14, 2016
Last Update Posted : April 6, 2022
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Condition or disease | Intervention/treatment | Phase |
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Neoplasms | Drug: letetresgene autoleucel (GSK3377794) Drug: Cyclophosphamide Drug: Fludarabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Study of NY-ESO-1c259T Cells in Subjects With Advanced Myxoid/ Round Cell Liposarcoma |
Actual Study Start Date : | December 6, 2016 |
Actual Primary Completion Date : | November 1, 2021 |
Actual Study Completion Date : | March 22, 2022 |

Arm | Intervention/treatment |
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Experimental: 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.
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Drug: letetresgene autoleucel (GSK3377794)
Letetresgene autoleucel (GSK3377794) as an IV infusion. Drug: Cyclophosphamide Cyclophosphamide will be used as a lymphodepleting chemotherapy. Drug: Fludarabine Fludarabine will be used as a lymphodepleting chemotherapy. |
- Overall Response Rate (ORR) per response evaluation criteria in solid tumors (RECIST) version 1.1 criteria by investigator assessment [ Time Frame: Up to 1 year ]ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) per RECIST version 1.1 criteria by investigator assessment relative to the total number of participants in the analysis population.
- Overall Response Rate (ORR) per RECIST version 1.1 criteria by independent review [ Time Frame: Up to 1 year ]ORR is defined as the proportion of participants with a confirmed CR or PR per RECIST version 1.1 criteria by independent review relative to the total number of participants in the analysis population.
- Time to response (TTR) [ Time Frame: Up to 1 year ]Time to Response is defined as the interval between T-cell infusion to the initial date of the confirmed response.
- Duration of response (DOR) [ Time Frame: Up to 1 year ]Duration of response is defined as the interval between the initial date of the confirmed response to the date of progressive disease or death.
- Progression Free Survival (PFS) [ Time Frame: Up to 1 year ]Progression free survival is defined as the interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause.
- Number of participants with adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs). [ Time Frame: Up to 1 year ]AEs, SAEs, and AESIs will be collected.
- Number of participants with clinically significant changes in hematology and clinical chemistry [ Time Frame: Up to 1 year ]Blood samples will be collected for assessment of hematology and clinical chemistry.
- Number of participants with replication competent lentivirus (RCL) [ Time Frame: Upto 1 year ]RCL exposure will be assessed by polymerase chain reaction (PCR) based assay
- Number of participants with insertional oncogenesis [ Time Frame: Upto 1 year ]Peripheral blood mononuclear cells (PBMC) samples will be collected for monitoring insertional oncogenesis by PCR for gene modified cells in the blood
- Number of participants with positive anti-drug antibodies (ADA) and titers of ADA against letetresgene autoleucel [ Time Frame: Up to 1 year ]Serum samples will be collected to analyze for the presence of ADAs using validated immunoassays.
- Maximum transgene expansion (Cmax) of letetresgene autoleucel [ Time Frame: Up to 1 year ]Blood samples will be collected to measure Cmax
- Time to Cmax (Tmax) [ Time Frame: Up to 1 year ]Blood samples will be collected to measure Tmax
- Area under the time curve from zero to time t AUC(0-t) of letetresgene autoleucel [ Time Frame: Up to 1 year ]Blood samples will be collected to measure AUC (0-t)
- Number of participants with abnormal electrocardiogram (ECG) parameters [ Time Frame: Up to 1 year ]Participants with abnormal ECG parameters will be assessed.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participant is greater than equal to (>=)18 years of age at the time of signing the study informed consent.
- 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 gene therapy using an integrating vector.
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02992743
United States, Florida | |
GSK Investigational Site | |
Tampa, Florida, United States, 33612 | |
United States, Michigan | |
GSK Investigational Site | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Missouri | |
GSK Investigational Site | |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
GSK Investigational Site | |
New York, New York, United States, 10065 | |
United States, Ohio | |
GSK Investigational Site | |
Columbus, Ohio, United States, 43210 | |
United States, Texas | |
GSK Investigational Site | |
Houston, Texas, United States, 77030 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT02992743 |
Other Study ID Numbers: |
208469 ADP-0011-007 ( Other Identifier: Adaptimmune Therapeutics ) |
First Posted: | December 14, 2016 Key Record Dates |
Last Update Posted: | April 6, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | IPD for this study will be made available via the Clinical Study Data Request site. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study. |
Access Criteria: | Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months. |
URL: | http://clinicalstudydatarequest.com |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Myxoid/ round cell liposarcoma Letetresgene autoleucel Immuno-oncology T Cell Receptor |
Leukapheresis NY-ESO-1 Adoptive TCR T-cell therapy |
Liposarcoma Liposarcoma, Myxoid Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma Cyclophosphamide Fludarabine |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |