Screening Protocol for Preliminary Eligibility Determination for Adoptive Cell Therapy Trials

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 2

Conditions: Neoplasms

Treatments: Other: Screening Platform

Study type: Interventional

Funder types: Industry

Identifiers

NCT05100316

213033

Details and patient eligibility

About

This screening study is intended to determine preliminary eligibility of participants who may be potential candidates for GlaxoSmithKline's Adoptive T-cell therapy studies by screening for appropriate biomarkers. No treatment intervention will occur as part of this screening study.

Enrollment: 16 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed diagnosis of locally advanced high-risk eligible tumor types .
• Participant must be greater than or equal to (>=)18 years of age (or >=10 years of age with synovial sarcoma or myxoid/round cell liposarcoma [MRCLS])
• Participants with life expectancy of greater than 6 months
• Performance status: Eastern Cooperative Oncology Group 0-1.

Exclusion criteria

• Any prior treatment with oncology cell and/or gene therapy (unless agreed in advance with Sponsor)
• Prior malignancy not in complete remission.
• Clinically significant systemic illness
• Serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction,
• Prior or active demyelinating disease
• Previous New-York Esophageal Antigen-1 (NY-ESO-1)-specific T cells, NY-ESO-1 vaccine, or NY-ESO-1 targeting antibody.
• Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Participants with solid tumors and hematological malignancies

Other group

Description:

Participants with solid tumors and hematological malignancies will be included. No study treatment will be administered in this study.

Treatment:

Other: Screening Platform