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Study of GSK3845097 in Previously Treated Participants With Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Study of GSK3845097 in Previously Treated Participants With Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma

Assessment of Safety and Recommended Phase 2 Dose of Autologous T Cells Engineered With an Affinity-enhanced TCR Targeting NY ESO 1 and LAGE 1a, and Co-expressing the dnTGF-βRII (GSK3845097) in Participants With NY ESO 1 and/or LAGE 1a Positive Previously Treated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma

NCT05943990•Adaptimmune

View on ClinicalTrials.gov

Summary

To assess the safety, tolerability and determine recommended phase 2 dose (RP2D) of GSK3845097 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, advanced (metastatic or unresectable) Synovial Sarcoma (SS) and Myxoid/Round Cell Liposarcoma (MRCLS).

Detailed Description

This study is a substudy of the Master record - (209012) NCT04526509.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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
+1 more criteria

Locations (21)

GSK Investigational Site

New Haven, Connecticut, United States

GSK Investigational Site

Jacksonville, Florida, United States

GSK Investigational Site

Tampa, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Westwood, Kansas, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Baltimore, Maryland, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

New York, New York, United States

Key Dates

Start Date

December 21, 2020

Primary Completion Date

October 24, 2022

Completion Date

October 24, 2022

Last Updated

November 13, 2024

Enrollment

ACTUAL participants

Conditions

Neoplasms

Interventions

GSK3845097

DRUG

Cyclophosphamide

DRUG

Fludarabine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of GSK3845097 in Previously Treated Participants With Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma

Inclusion Criteria

Exclusion Criteria

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