NCT03697824

Clinical Trial of Safety, Tolerability and Antitumor Activity of Genetically Engineered T Cells in Combination With Anti-Cancer Agents in Relapsed and Refractory Synovial Sarcoma Expressing New York Esophageal Antigen-1 (NY-ESO-1) and/or LAGE-1a

Withdrawn Phase 2 Last updated 29 October 2019

What this trial tests

Phase 2 trial testing GSK3377794 in Neoplasms. Withdrawn.

Timeline

25 February 2019

Primary endpoint
18 July 2022

18 July 2022

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	25 February 2019
Primary completion	18 July 2022
Estimated completion	18 July 2022

Drugs / interventions tested

• GSK3377794 — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →

Conditions studied

• Neoplasms — all drugs for Neoplasms →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

10 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Adoptive T-cell therapy is a therapeutic approach that aims to generate an anti-tumor T-cell immune response by infusing a cancer subjects own T-cells obtained by leukapheresis, engineered and expanded in-vitro to express a tumor specific T-cell receptor. NY-ESO-1 and LAGE-1a antigens are tumor-associated proteins that have been found in several tumor types, including synovial sarcoma. This is an open-label study to evaluate the safety and efficacy of GSK3377794 (genetically engineered NY-ESO-1 Specific \[c259\] T Cells), in combination with anticancer agents including pembrolizumab in subjects with NY-ESO-1 and/or LAGE-1a positive relapsed and refractory synovial sarcoma. The study will consist of a target expression screening to determine if subjects are human leukocyte antigen (HLA)-A\*02:01, HLA-A\*02:05 and/or HLA-A\*02:06 positive and if their tumors express NY-ESO-1 and/or LAGE-1a, followed by a leukapheresis screening phase of up to 42 days prior to leukapheresis. Eligible subjects will enter a leukapheresis phase followed by lymphodepletion phase with cyclophosphamide and fludarabine. During the treatment phase, subjects will be administered GSK3377794 on Day 1 followed by pembrolizumab infusion once every 3 weeks from Day 22 (or Week 7) for up to 2 years. There will be a long-term follow-up phase from the end of treatment phase and for up to 15 years from the date of GSK3377794 administration.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trial watch: chemotherapy-induced immunogenic cell death in immuno-oncology.
   Vanmeerbeek I, Sprooten J, De Ruysscher D, Tejpar S, et al · · 2020 · cited 179× · PMID 32002302 · DOI 10.1080/2162402x.2019.1703449
2. The screening, identification, design and clinical application of tumor-specific neoantigens for TCR-T cells.
   Li J, Xiao Z, Wang D, Jia L, et al · · 2023 · cited 52× · PMID 37649123 · DOI 10.1186/s12943-023-01844-5
3. Opportunities and Challenges in Drug Development for Pediatric Cancers.
   Laetsch TW, DuBois SG, Bender JG, Macy ME, et al · · 2021 · cited 45× · PMID 33277309 · DOI 10.1158/2159-8290.cd-20-0779
4. Biomarkers for immune checkpoint inhibition in sarcomas - are we close to clinical implementation?
   Yiong CS, Lin TP, Lim VY, Toh TB, et al · · 2023 · cited 26× · PMID 37612756 · DOI 10.1186/s40364-023-00513-5
5. Recent advances and application of PD-1 blockade in sarcoma.
   Zuo W, Zhao L. · · 2019 · cited 15× · PMID 31692518 · DOI 10.2147/ott.s220045
6. Transgenic T-cell receptor immunotherapy for cancer: building on clinical success.
   Oppermans N, Kueberuwa G, Hawkins RE, Bridgeman JS. · · 2020 · cited 9× · PMID 32613155 · DOI 10.1177/2515135520933509