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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
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
Secondary ID [1] 0 0
209012 Substudy 1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
Up to 28 days
Primary outcome [2] 0 0
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs Based on Maximum Severity
Timepoint [2] 0 0
Up to approximately 21 months
Primary outcome [3] 0 0
Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESI)
Timepoint [3] 0 0
Up to approximately 21 months
Secondary outcome [1] 0 0
Overall Response Rate (ORR) Assessed by Investigator According to RECIST v1.1
Timepoint [1] 0 0
Up to approximately 21 months
Secondary outcome [2] 0 0
Duration of Response (DoR)
Timepoint [2] 0 0
Up to approximately 21 months
Secondary outcome [3] 0 0
Maximum Transgene Expansion (Cmax) of GSK3901961
Timepoint [3] 0 0
Up to 21 days
Secondary outcome [4] 0 0
Time to Cmax (Tmax) of GSK3901961
Timepoint [4] 0 0
Up to 21 days
Secondary outcome [5] 0 0
Area Under the Time Curve From Zero to Time 28 Days AUC(0-28)
Timepoint [5] 0 0
Up to 28 days

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/06/2023
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Germany
State/province [13] 0 0
Bayern
Country [14] 0 0
Germany
State/province [14] 0 0
Niedersachsen
Country [15] 0 0
Germany
State/province [15] 0 0
Nordrhein-Westfalen
Country [16] 0 0
Germany
State/province [16] 0 0
Sachsen
Country [17] 0 0
Netherlands
State/province [17] 0 0
Amsterdam
Country [18] 0 0
Sweden
State/province [18] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06048705
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06048705