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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06048705
Registration number
NCT06048705
Ethics application status
Date submitted
15/09/2023
Date registered
21/09/2023
Date last updated
10/05/2024
Titles & IDs
Public title
Study of GSK3901961 In Previously Treated Advanced (Metastatic OR Unresectable) Synovial Sarcoma/ Myxoid/Round Cell Liposarcoma, and Previously Treated Metastatic Non-Small Cell Lung Cancer
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Scientific title
Assessment of Safety and Recommended Phase 2 Dose of Autologous T Cells Engineered With an Affinity-enhanced TCR Targeting NYESO1 and LAGE1a, and Co-expressing CD8a (GSK3901961) in Participants With NYESO1 and/or LAGE1a Positive Previously Treated Advanced (Metastatic or Unresectable) Synovial Sarcoma / Myxoid/Round Cell Liposarcoma; or NYESO1 and/or LAGE1a Positive Previously Treated Metastatic Non-Small Cell Lung Cancer
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Secondary ID [1]
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209012 Substudy 1
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Cancer
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Sarcoma (also see 'Bone') - soft tissue
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Cancer
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Bone
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Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GSK3901961
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Fludarabine
Experimental: GSK3901961 - Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive high dose of GSK3901961 after completing lymphodepleting chemotherapy. The first study participant receiving GSK3901961 will receive the total assigned dose as 2 separate infusions 7 days apart, in aliquots of 30% (first infusion) and 70% (second infusion) of the total target dose, respectively. Based on the dose limiting toxicities reported in the first participant, then all subsequent participants treated with GSK3901961 will receive the full dose as a single, i.e., one-time, infusion.
Treatment: Drugs: GSK3901961
GSK3901961 was administered.
Treatment: Drugs: Cyclophosphamide
Cyclophosphamide was administered as lymphodepleting chemotherapy.
Treatment: Drugs: Fludarabine
Fludarabine was administered as lymphodepleting chemotherapy.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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DLT events were graded according to NCI-CTCAE v5.0. DLTs were defined as Grade (Gr) 4 (life-threatening and death) related to GSK3901961 2) Gr 3 (Severe or medically significant) at least possibly related to GSK3901961 and do not resolve to Gr <=1 (or Baseline) within 7 days from the onset of the event 3) Gr >=3 non-infectious pneumonitis not responding to oxygen supplementation and systemic steroid treatment 4) Any Gr 3 cytokine release syndrome (CRS) at least possibly related to GSK3901961 that does not improve to Gr <2 (moderate) toxicity within 7 days with or without dexamethasone 5) Any Gr 4 CRS at least possibly related to study product that does not improve to Gr <=2 (or Baseline) within 7 days 6) Any Gr 3 or greater neurotoxicity that does not resolve to Gr <=2 within 72 hours 7) Any Gr >=3 organ toxicity (exclusive of CRS toxicity) involving major organ systems that persists for >72 hours and occurs within 28 days of infusion.
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Timepoint [1]
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Up to 28 days
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Primary outcome [2]
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Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs Based on Maximum Severity
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Assessment method [2]
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An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any untoward medical occurrence that, at any dose can result in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth or is medically significant or requires intervention to prevent one or the outcomes listed above. AEs and SAEs were graded according to NCI-CTCAE v5.0. Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences; Grade 5- Death related to AE. AEs which start or worsen on or after T-cell infusion are classified as treatment emergent. SAEs are subset of AEs. Results for maximum severity grades has been presented.
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Timepoint [2]
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Up to approximately 21 months
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Primary outcome [3]
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Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESI)
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Assessment method [3]
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An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. AESIs included events of Cytokine Release Syndrome (CRS), Haematopoietic cytopenias (including pancytopenia and aplastic anaemia), Graft versus Host Disease (GvHD), Immune Effector-Cell Associated Neurotoxicity Syndrome (ICANS), Guillain-Barre Syndrome (GBS), Pneumonitis and treatment-related inflammatory response at tumor site(s) and Neutropenia Grade 4 lasting more than or equal to 28 days. AEs which start or worsen on or after T-cell infusion are classified as treatment emergent.
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Timepoint [3]
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Up to approximately 21 months
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Secondary outcome [1]
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Overall Response Rate (ORR) Assessed by Investigator According to RECIST v1.1
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Assessment method [1]
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Overall response rate (ORR) defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via investigator assessment per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 relative to the total number of participants in the analysis population. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response (CR) was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method.
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Timepoint [1]
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Up to approximately 21 months
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Secondary outcome [2]
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Duration of Response (DoR)
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Assessment method [2]
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DoR is defined as the interval of time (in months) from first documented evidence of the confirmed response (PR or CR) as assessed by local investigators to the date of disease progression per RECIST v1.1 or death due to any cause, among participants with a confirmed response of PR or CR. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
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Timepoint [2]
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Up to approximately 21 months
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Secondary outcome [3]
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Maximum Transgene Expansion (Cmax) of GSK3901961
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Assessment method [3]
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Cmax was defined as peak cell expansion during the interventional phase. Blood samples were collected to measure Cmax.
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Timepoint [3]
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Up to 21 days
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Secondary outcome [4]
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Time to Cmax (Tmax) of GSK3901961
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Assessment method [4]
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Tmax was defined as time to peak cell expansion during the interventional phase. Blood samples were collected to measure Tmax.
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Timepoint [4]
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Up to 21 days
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Secondary outcome [5]
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Area Under the Time Curve From Zero to Time 28 Days AUC(0-28)
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Assessment method [5]
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Area under the cell expansion-time curve from first T-cell infusion to Day 28. Blood samples were collected to measure AUC (0-28 days).
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Timepoint [5]
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Up to 28 days
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Eligibility
Key inclusion criteria
- Participant must be >=18 years of age and weighs =40 kg on the day of signing informed
consent
- Participant must be positive for HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 alleles
- Participant's tumor must have tested positive for NY-ESO-1 and/or LAGE-1a expression
by a GSK designated laboratory
- Performance status: Eastern Cooperative Oncology Group of 0-1
- Participant must have adequate organ function and blood cell counts 7 days prior to
leukapheresis
- Participant must have measurable disease according to RECIST v1.1.
- Participant has advanced (metastatic or unresectable) SS or MRCLS confirmed by local
histopathology with evidence of disease-specific translocation
- Participant has completed at least one standard of care (SOC) treatment including
anthracycline containing regimen unless intolerant to or ineligible to receive the
therapy.
- Participants who are not candidates to receive anthracycline should have received
ifosfamide unless also intolerant to or ineligible to receive ifosfamide. Participants
who received neoadjuvant/adjuvant anthracycline or ifosfamide based therapy and
progressed will be eligible
- Participant has histologically or cytologically confirmed Stage IV NSCLC
- Participant has been previously treated with SOC for Stage IV NSCLC
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Central nervous system (CNS) metastases, with certain exceptions for CNS metastases in
NSCLC as specified in the protocol
- Any other prior malignancy that is not in complete remission
- Clinically significant systemic illness
- Prior or active demyelinating disease
- History of chronic or recurrent (within the last year prior to leukapheresis) severe
autoimmune or immune mediated disease requiring steroids or other immunosuppressive
treatments
- Previous treatment with genetically engineered NY-ESO-1-specific T cells, NY-ESO-1
vaccine or NY-ESO-1 targeting antibody
- Prior gene therapy using an integrating vector
- Previous allogeneic hematopoietic stem cell transplant within the last 5 years or
solid organ transplant
- Washout periods for prior radiotherapy and systemic chemotherapy must be followed
- Major surgery within 4 weeks prior to lymphodepletion
- Pregnant or breastfeeding females
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/03/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/06/2023
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Sample size
Target
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Accrual to date
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Final
7
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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GSK Investigational Site - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Connecticut
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
0
0
United States of America
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State/province [3]
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Georgia
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Country [4]
0
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United States of America
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State/province [4]
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Kansas
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Country [5]
0
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United States of America
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State/province [5]
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Kentucky
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Country [6]
0
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United States of America
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State/province [6]
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Maryland
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Country [7]
0
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United States of America
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State/province [7]
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Missouri
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Country [8]
0
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United States of America
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State/province [8]
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New York
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Country [9]
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United States of America
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State/province [9]
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Pennsylvania
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Country [10]
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United States of America
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State/province [10]
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Texas
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Country [11]
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Canada
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State/province [11]
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Ontario
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Country [12]
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Canada
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State/province [12]
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Quebec
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Country [13]
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Germany
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State/province [13]
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Bayern
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Country [14]
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Germany
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State/province [14]
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Niedersachsen
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Country [15]
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Germany
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State/province [15]
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Nordrhein-Westfalen
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Country [16]
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Germany
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State/province [16]
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Sachsen
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Country [17]
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Netherlands
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State/province [17]
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Amsterdam
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Country [18]
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Sweden
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State/province [18]
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Stockholm
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary purpose of this sub study is to assess the safety, tolerability and determine recommended Phase 2 dose (RP2D) of GSK3901961 in HLA A*02:01, HLA-A*02:05 and/or HLA A*02:06 positive participants with New York esophageal squamous cell carcinoma (NY ESO 1) and/or Cancer testis antigen 2 (LAGE 1a) positive previously treated metastatic Non-Small Cell Lung Cancer (NSCLC) and previously treated, advanced (metastatic or unresectable) Synovial Sarcoma/ Myxoid/Round Cell Liposarcoma SS/MRCLS.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06048705
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/ct2/show/NCT06048705
Download to PDF