NCT02070406

Gene-Modified T Cells, Vaccine Therapy, and Ipilimumab in Treating Patients With Locally Advanced or Metastatic Malignancies

Terminated Phase 1 Last updated 28 February 2019

What this trial tests

Phase 1 trial testing cyclophosphamide in Unspecified Adult Solid Tumor, Protocol Specific in 4 participants. Terminated before completion.

Timeline

17 July 2014

Primary endpoint
18 December 2018

18 December 2018

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	4
Start date	17 July 2014
Primary completion	18 December 2018
Estimated completion	18 December 2018
Sites	1 location across United States

Drugs / interventions tested

• cyclophosphamide (cyclophosphamide) — full drug profile →
• fludarabine phosphate (FLUDARABINE PHOSPHATE) — full drug profile →
• NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL
• dendritic cell vaccine therapy
• aldesleukin (ALDESLEUKIN) — full drug profile →
• fludeoxyglucose F 18
• positron emission tomography
• laboratory biomarker analysis

Conditions studied

• Unspecified Adult Solid Tumor, Protocol Specific — all drugs for Unspecified Adult Solid Tumor, Protocol Specific →

Sponsor

Jonsson Comprehensive Cancer Center — full company profile →

Who can join

16 and older, any sex, with Unspecified Adult Solid Tumor, Protocol Specific. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This pilot phase I trial studies the side effects of taking ipilimumab after gene-modified T cells and vaccine therapy when treating patients with advanced cancer that has spread to other areas of the body and has not responded to standard therapies. This trial also will determine the best dose of Ipilimumab to use in this combination treatment. T cells are a special type of white blood cell (immune cell) that have the ability to kill cancer cells. T cells are taken from the blood and modified in the laboratory to recognize a specific protein expressed on cancer cells, called NY-ESO-1. This may allow the T cells to target and kill cancer cells that express that protein. Dendritic cells are another type of blood cell that can teach other cells in the body to look for cancer cells and attack them. Giving a dendritic cell vaccine with the NY-ESO-1 protein may help dendritic cells teach the immune system to target cancer cells expressing that protein, and further help the T cells attack cancer. Ipilimumab is a monoclonal antibody, a type of drug manufactured in the laboratory that is similar to antibodies made in the human body that fight off infection. Ipilimumab blocks a protein that turns down the immune system, so blocking this protein may make the immune system more active. This may increase the ability of immune cells to kill cancer cells and improve the effectiveness of the T cell transplant. Giving gene-modified T-cells, a dendritic cell vaccine, and ipilimumab together may teach the immune system to recognize and kill cancer cells that have the NY-ESO-1 protein.

Publications & conference data

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

1. Engineered T cells: the promise and challenges of cancer immunotherapy.
   Fesnak AD, June CH, Levine BL. · · 2016 · cited 812× · PMID 27550819 · DOI 10.1038/nrc.2016.97
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. TCR-engineered T cell therapy in solid tumors: State of the art and perspectives.
   Baulu E, Gardet C, Chuvin N, Depil S. · · 2023 · cited 283× · PMID 36791198 · DOI 10.1126/sciadv.adf3700
4. Trial Watch: Immunogenic cell death inducers for anticancer chemotherapy.
   Pol J, Vacchelli E, Aranda F, Castoldi F, et al · · 2015 · cited 238× · PMID 26137404 · DOI 10.1080/2162402x.2015.1008866
5. Driving gene-engineered T cell immunotherapy of cancer.
   Johnson LA, June CH. · · 2017 · cited 211× · PMID 28025979 · DOI 10.1038/cr.2016.154
6. Cancer Therapy With TCR-Engineered T Cells: Current Strategies, Challenges, and Prospects.
   Shafer P, Kelly LM, Hoyos V. · · 2022 · cited 181× · PMID 35309357 · DOI 10.3389/fimmu.2022.835762
7. CRISPR/Cas9 mediated deletion of the adenosine A2A receptor enhances CAR T cell efficacy.
   Giuffrida L, Sek K, Henderson MA, Lai J, et al · · 2021 · cited 177× · PMID 34050151 · DOI 10.1038/s41467-021-23331-5
8. Towards superior dendritic-cell vaccines for cancer therapy.
   Saxena M, Balan S, Roudko V, Bhardwaj N. · · 2018 · cited 99× · PMID 30116654 · DOI 10.1038/s41551-018-0250-x