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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04526509
Other study ID # 209012
Secondary ID 2019-004446-14
Status Terminated
Phase Phase 1
First received
Last updated
Start date December 21, 2020
Est. completion date June 8, 2023

Study information

Verified date November 2023
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial will evaluate the safety and efficacy of first time in human engineered T-cell therapies, in participants with advanced tumors.


Description:

This study is a master protocol. It has two sub studies registered as 209012 Sub Study 1 (NCT06048705) and 209012 Sub Study 2 (NCT05943990).


Recruitment information / eligibility

Status Terminated
Enrollment 12
Est. completion date June 8, 2023
Est. primary completion date June 8, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Eligibility Criteria: 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. Additional criteria for participants with SS/ MRCLS: - 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 Additional criteria for participants with non-small cell lung cancer (NSCLC): - Participant has Stage IV NSCLC as confirmed by histology or cytology - Prior therapies for participants lacking actionable genetic aberrations (i.e., wild type), per National Comprehensive Cancer Network (NCCN) guidelines: participant has been previously treated with or is intolerant to programmed death receptor-1 (PD)-1/Programmed death ligand 1 (PD-L1) checkpoint blockade therapy and has been previously treated with or is intolerant to a platinum-based chemotherapy. Adjuvant therapy will count as a regimen if completed within 6 months before relapse. Or for participants that harbors an actionable genetic aberration (e.g. BRAF, anaplastic lymphoma kinase [ALK]/ c-ros oncogene 1 [ROS1] etc.), per NCCN guidelines: participants has been previously treated with or is intolerant to SOC therapy, including targeted therapy, as recommended by NCCN or equivalent country-level guidelines (European Society for Medical Oncology [ESMO], National Institute for Health & Care Excellence [NICE]) . Or Investigator has decided that additional lines of SOC therapy after the first line are not in the participant's best interest. 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


Related Conditions & MeSH terms


Intervention

Drug:
GSK3901961
GSK3901961 as an IV infusion.
GSK3845097
GSK3845097 as an IV infusion.
GSK4427296
GSK4427296 as an IV infusion.
Cyclophosphamide
Cyclophosphamide will be used as lymphodepleting chemotherapy and will be administered via IV route.
Fludarabine
Fludarabine will be used as lymphodepleting chemotherapy and will be administered via IV route.

Locations

Country Name City State
Australia GSK Investigational Site Melbourne Victoria
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Toronto Ontario
Germany GSK Investigational Site Dresden Sachsen
Germany GSK Investigational Site Koeln Nordrhein-Westfalen
Germany GSK Investigational Site Muenchen Bayern
Netherlands GSK Investigational Site Amsterdam
Sweden GSK Investigational Site Stockholm
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Baltimore Maryland
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Jacksonville Florida
United States GSK Investigational Site Lexington Kentucky
United States GSK Investigational Site New York New York
United States GSK Investigational Site New York New York
United States GSK Investigational Site Saint Louis Missouri
United States GSK Investigational Site Westwood Kansas

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Netherlands,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Enrolled Across Sub Studies Number of Participants Randomized across sub studies are presented. Day -7
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