NCT04526509 : Master Protocol to Assess the Safety and Recommended Phase 2 Dose of Next Generations of Autologous Enhanced NY-ESO-1/ LAGE-1a TCR Engineered T-cells, Alone or in Combination With Other Agents, in Participants With Advanced Tumors

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Lung,SarcomaNon-Small Cell Lung Cancer,Synovial Sarcoma

Trial Overview Read MoreRead more

This Phase I trial is trying to understand the safety and effectiveness of targeted immunotherapy people with previously untreated synovial sarcoma and/or non-small cell lung cancer .
 

This trial is treating patients with HLA*A02+ Synovial Sarcoma and Non-Small Cell Lung Cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

Master Protocol to Assess the Safety and Recommended Phase 2 Dose of Next Generations of Autologous Enhanced NY-ESO-1/ LAGE-1a TCR Engineered T-cells, Alone or in Combination With Other Agents, in Participants With Advanced Tumors

Commercial Sponsor

GlaxoSmithKline

Summary

This is a master protocol evaluating first time in human T-cell therapies. It will initially consist of two independent substudies, investigating GSK3901961 and GSK3845097 in HLA*A02+ participants with NYESO1+ previously treated advanced (metastatic or unresectable) synovial sarcoma (SS) and/or previously treated metastatic non-small cell lung cancer (NSCLC). In Substudy 1: GSK3901961 in previously treated advanced SS, eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as a single intravenous (IV) infusion after completing lymphodepleting chemotherapy. In Substudy 1: GSK3901961 in previously treated metastatic NSCLC, eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as a single IV infusion after completing lymphodepleting chemotherapy. In Substudy 2: Substudy 2: GSK3845097 in previously treated advanced SS, eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3845097, as a single IV infusion after completing lymphodepleting chemotherapy.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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