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Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors

NCT03967223 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2026-04-17

No results posted yet for this study

Summary

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

Conditions

  • Neoplasms

Interventions

DRUG

Letetresgene autoleucel (lete-cel, GSK3377794)

letetresgene autoleucel will be administered.

DRUG

Fludarabine

Fludarabine will be used as the lymphodepleting chemotherapy

DRUG

Cyclophosphamide

Cyclophosphamide will be used as the lymphodepleting chemotherapy.

Sponsors & Collaborators

  • USWM CT, LLC

    lead INDUSTRY

Principal Investigators

  • Michael Nathenson, MD · USWM CT, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2024-03-01
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03967223 on ClinicalTrials.gov