Last updated: 03/23/2023 12:10:26
Letetresgene autoleucel Engineered T Cells in NY-ESO-1 Positive participants with Advanced Myxoid/ Round Cell Liposarcoma
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Pilot Study of NY-ESO-1c259T Cells in Subjects with Advanced Myxoid/ Round Cell Liposarcoma
Trial description: This trial will evaluate safety and efficacy of Letetresgene autoleucel (GSK3377794) in participants with advanced myxoid/round cell liposarcoma or high-grade myxoid liposarcoma.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Overall Response Rate (ORR) per response evaluation criteria in solid tumors (RECIST) version 1.1 criteria by investigator assessment
Timeframe: Up to 1 year
Secondary outcomes:
Overall Response Rate (ORR) per RECIST version 1.1 criteria by independent review
Timeframe: Up to 1 year
Time to response (TTR)
Timeframe: Up to 1 year
Duration of response (DOR)
Timeframe: Up to 1 year
Progression Free Survival (PFS)
Timeframe: Up to 1 year
Number of participants with adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs).
Timeframe: Up to 1 year
Number of participants with clinically significant changes in hematology and clinical chemistry
Timeframe: Up to 1 year
Number of participants with replication competent lentivirus (RCL)
Timeframe: Upto 1 year
Number of participants with insertional oncogenesis
Timeframe: Upto 1 year
Number of participants with positive anti-drug antibodies (ADA) and titers of ADA against letetresgene autoleucel
Timeframe: Up to 1 year
Maximum transgene expansion (Cmax) of letetresgene autoleucel
Timeframe: Up to 1 year
Time to Cmax (Tmax)
Timeframe: Up to 1 year
Area under the time curve from zero to time t AUC(0-t) of letetresgene autoleucel
Timeframe: Up to 1 year
Number of participants with abnormal electrocardiogram (ECG) parameters
Timeframe: Up to 1 year
Interventions:
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: letetresgene autoleucel (GSK3377794)
Enrollment:
23
Observational study model:
Not applicable
Primary completion date:
2021-01-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms
Product
GSK3377794, cyclophosphamide, fludarabine
Collaborators
NA
Study date(s)
December 2016 to March 2022
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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).
- Any previous gene therapy using an integrating vector.
- Any previous allogeneic hematopoietic stem cell transplant.
Inclusion and exclusion criteria
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).
Trial location(s)
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10065
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63110
Status
Study Complete
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2021-01-11
Actual study completion date
2022-22-03
Plain language summaries
Summary of results in plain language
Available language(s): English, Spanish (United States)
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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