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TerminatedPhase 1NCT06048705
Official study 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

Study 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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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedGSK3901961 and Cyclophosphamide

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 13, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?21 U.S. locations

Locations may change over time.

Who runs it?Adaptimmune

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Adaptimmune
Interventions being studied
Drug: GSK3901961; Drug: Cyclophosphamide; Drug: Fludarabine
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Early-stage or resectable→Metastatic or stage IV→
Study topics
After prior treatment→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • GSK Investigational SiteNew Haven, Connecticut
  • GSK Investigational SiteJacksonville, Florida
  • GSK Investigational SiteTampa, Florida
  • GSK Investigational SiteAtlanta, Georgia
  • GSK Investigational SiteWestwood, Kansas
  • GSK Investigational SiteLexington, Kentucky
  • GSK Investigational SiteBaltimore, Maryland
  • GSK Investigational SiteSt Louis, Missouri
  • GSK Investigational SiteNew York, New York
  • GSK Investigational SiteNew York, New York
  • GSK Investigational SitePhiladelphia, Pennsylvania
  • GSK Investigational SiteHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 13, 2024. Always confirm current availability with the study team.

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