NCT03240861: NYESO SCT

Genetically Engineered PBMC and PBSC Expressing NY-ESO-1 TCR After a Myeloablative Conditioning Regimen to Treat Patients With Advanced Cancer

Terminated Phase 1 Last updated 1 November 2023

What this trial tests

Phase 1 trial testing 18F-FHBG in HLA-A*0201 Positive Cells Present in 5 participants. Terminated before completion.

Timeline

26 July 2017

Primary endpoint
19 October 2023

19 October 2023

Quick facts

Lead sponsor	Jonsson Comprehensive Cancer Center
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	26 July 2017
Primary completion	19 October 2023
Estimated completion	19 October 2023
Sites	1 location across United States

Drugs / interventions tested

• 18F-FHBG
• Aldesleukin (ALDESLEUKIN) — full drug profile →
• Busulfan — full drug profile →
• Cellular Therapy
• Computed Tomography
• Filgrastim
• Fludarabine (FLUDARABINE) — full drug profile →
• Leukapheresis — full drug profile →
• Plerixafor (plerixafor) — full drug profile →
• Positron Emission Tomography

Conditions studied

• HLA-A*0201 Positive Cells Present — all drugs for HLA-A*0201 Positive Cells Present →
• Locally Advanced Malignant Neoplasm — all drugs for Locally Advanced Malignant Neoplasm →
• NY-ESO-1 Positive — all drugs for NY-ESO-1 Positive →
• Unresectable Malignant Neoplasm — all drugs for Unresectable Malignant Neoplasm →

Sponsor

Jonsson Comprehensive Cancer Center — full company profile →

Who can join

16 and older, any sex, with HLA-A*0201 Positive Cells Present or Locally Advanced Malignant Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I clinical trial evaluates the safety and feasibility of administering NY-ESO-1 TCR (T cell receptor)engineered peripheral blood mononuclear cells (PBMC) and peripheral blood stem cells (PBSC) after a myeloablative conditioning regimen to treat patients with cancer that has spread to other parts of the body. The conditioning chemotherapy makes room in the patient?s bone marrow for new blood cells (PBMC) and blood-forming cells (stem cells) to grow. Giving NY-ESO-1 TCR PBMC and stem cells after the conditioning chemotherapy is intended to replace the immune system with new immune cells that have been redirected to attack and kill the cancer cells and thereby improve immune system function against cancer.

Publications & conference data

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

1. Inflammation and tumor progression: signaling pathways and targeted intervention.
   Zhao H, Wu L, Yan G, Chen Y, et al · · 2021 · cited 1932× · PMID 34248142 · DOI 10.1038/s41392-021-00658-5
2. NY-ESO-1 Based Immunotherapy of Cancer: Current Perspectives.
   Thomas R, Al-Khadairi G, Roelands J, Hendrickx W, et al · · 2018 · cited 298× · PMID 29770138 · DOI 10.3389/fimmu.2018.00947
3. A Pilot Trial of the Combination of Transgenic NY-ESO-1-reactive Adoptive Cellular Therapy with Dendritic Cell Vaccination with or without Ipilimumab.
   Nowicki TS, Berent-Maoz B, Cheung-Lau G, Huang RR, et al · · 2019 · cited 76× · PMID 30573690 · DOI 10.1158/1078-0432.ccr-18-3496
4. Improving Immunotherapy Efficacy in Soft-Tissue Sarcomas: A Biomarker Driven and Histotype Tailored Review.
   Roulleaux Dugage M, Nassif EF, Italiano A, Bahleda R. · · 2021 · cited 73× · PMID 34925348 · DOI 10.3389/fimmu.2021.775761
5. Landscape of Myeloid-derived Suppressor Cell in Tumor Immunotherapy.
   Hao Z, Li R, Wang Y, Li S, et al · · 2021 · cited 72× · PMID 34689842 · DOI 10.1186/s40364-021-00333-5
6. 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
7. Biology of Cancer-Testis Antigens and Their Therapeutic Implications in Cancer.
   Nin DS, Deng LW. · · 2023 · cited 45× · PMID 36980267 · DOI 10.3390/cells12060926
8. Diagnosis, grading and management of toxicities from immunotherapies in children, adolescents and young adults with cancer.
   Ragoonanan D, Khazal SJ, Abdel-Azim H, McCall D, et al · · 2021 · cited 39× · PMID 33608690 · DOI 10.1038/s41571-021-00474-4