Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells Specific in NY-ESO-1/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab

Official Title

A Phase 1b/2a Pilot Study to Evaluate the Safety and Tolerability of Autologous T-Cells Expressing Enhanced TCRs (T Cell Receptors) Specific for NY-ESO-1/LAGE-1a (GSK3377794) Alone, or in Combination With Pembrolizumab in HLA-A2+ Participants With NY-ESO-1- or LAGE-1a-Positive Advanced or Recurrent Non-Small Cell Lung Cancer

Summary:

This trial will evaluate safety and efficacy of letetresgene autoleucel (GSK3377794) with or without pembrolizumab in participants with non-small cell lung cancer.

Trial Description

Primary Outcome:

  • Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESIs) based on severity
  • AEs and SAEs leading to dose delays and/or withdrawals
  • Overall response rate (ORR)
Secondary Outcome:
  • Progression-Free Survival (PFS)
  • Disease Control Rate (DCR)
  • Duration of Response (DoR)
  • Time to Response (TTR)
  • Maximum transgene expansion (Cmax) for lete-cel
  • Time to Cmax (Tmax) for lete-cel
  • Area under the time curve from zero to time t (AUC[0 to t]) of GSK3377794
New York esophageal antigen-1 (NY-ESO-1) and LAGE-1a antigens are tumour-associated proteins that have been found in several tumour types. Clinical trials using adoptively transferred T-cells directed against NY-ESO-1/LAGE-1a have shown objective responses. Letetresgene autoleucel (GSK3377794) is the first generation of NY-ESO-1 specific T-cell receptor (TCR) engineered T-cells. This protocol investigates Letetresgene autoleucel treatment in Human Leukocyte Antigen (HLA)-A*02+ participants with NY-ESO1+ advanced myxoid/round cell liposarcoma or high-grade myxoid liposarcoma.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society