Status:
TERMINATED
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
Lead Sponsor:
Adaptimmune
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 parti...
Detailed Description
This study is a substudy of the Master record - (209012) NCT04526509.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT06048705
Start Date
March 9 2021
End Date
June 8 2023
Last Update
November 13 2024
Active Locations (21)
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1
GSK Investigational Site
New Haven, Connecticut, United States, 06504
2
GSK Investigational Site
Jacksonville, Florida, United States, 32224
3
GSK Investigational Site
Tampa, Florida, United States, 33612
4
GSK Investigational Site
Atlanta, Georgia, United States, 30322