NCT03412526

Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Ovarian

Status unknown Phase 2 Last updated 4 April 2019

What this trial tests

Phase 2 trial testing Fludarabine in Metastatic Ovarian Cancer in 15 participants. Status unknown.

Timeline

21 January 2018

Primary endpoint
1 February 2021

1 February 2022

Quick facts

Lead sponsor	Sheba Medical Center
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	21 January 2018
Primary completion	1 February 2021
Estimated completion	1 February 2022
Sites	1 location across Israel

Drugs / interventions tested

• Fludarabine (FLUDARABINE) — full drug profile →
• Radiation
• TIL administration — full drug profile →
• IL-2 — full drug profile →

Conditions studied

• Metastatic Ovarian Cancer — all drugs for Metastatic Ovarian Cancer →

Sponsor

Sheba Medical Center

Who can join

Adults 18 to 80, female only, with Metastatic Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Adoptive cell therapy (ACT) with tumor-infiltrating lymphocytes (TILs) in combination with lymphodepletion and high-dose interleukin 2.

Most TIL ACT trials have been conducted as salvage therapy for patients who already had failed numerous treatments; many study participants presented with multiple metastases, frequently in visceral organs and even in the brain. The effectiveness of TIL ACT in eradicating metastatic tumors of the responding patients underlines the value of this immunotherapeutic approach.

Recent developments in the identification and selection of tumor-specific T-cell populations have facilitated the implementation of TIL ACT also in nonmelanoma malignancies. Building on the experience of Ella Lemelbaum Institute, Sheba Medical Center with ACT TIL in the treatment of metastatic melanoma, the Dept. of Oncology, Tel HaShomer has expanded the use of TIL ACT following a reduced intensity, non-myeloablative, lymphodepleting induction regimen to metastatic Melanoma, Ovarian (OC) and Cervical cancer patients. The rationale supporting these studies is to further develop the ACT TIL procedure and expand its applicability to metastatic OC and cervical cancers.

Publications & conference data

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

1. Tumor-infiltrating lymphocytes for treatment of solid tumors: It takes two to tango?
   Kazemi MH, Sadri M, Najafi A, Rahimi A, et al · · 2022 · cited 113× · PMID 36389779 · DOI 10.3389/fimmu.2022.1018962
2. Cell therapies in ovarian cancer.
   Sarivalasis A, Morotti M, Mulvey A, Imbimbo M, et al · · 2021 · cited 30× · PMID 33995591 · DOI 10.1177/17588359211008399
3. Immunotherapy Advances for Epithelial Ovarian Cancer.
   Hartnett EG, Knight J, Radolec M, Buckanovich RJ, et al · · 2020 · cited 25× · PMID 33322601 · DOI 10.3390/cancers12123733
4. Adoptive cell transfer using autologous tumor infiltrating lymphocytes in gynecologic malignancies.
   Mayor P, Starbuck K, Zsiros E. · · 2018 · cited 24× · PMID 29803316 · DOI 10.1016/j.ygyno.2018.05.024
5. New emerging targets in cancer immunotherapy: the role of neoantigens.
   De Mattos-Arruda L, Blanco-Heredia J, Aguilar-Gurrieri C, Carrillo J, et al · · 2020 · cited 23× · PMID 32269031 · DOI 10.1136/esmoopen-2020-000684
6. Radiotherapy as a means to increase the efficacy of T-cell therapy in solid tumors.
   Laurent PA, Morel D, Meziani L, Depil S, et al · · 2023 · cited 21× · PMID 36567802 · DOI 10.1080/2162402x.2022.2158013
7. The Role of Neoantigens in Cancer Immunotherapy.
   Zhu Y, Liu J. · · 2021 · cited 17× · PMID 34513673 · DOI 10.3389/fonc.2021.682325
8. The Landscape of Adoptive Cellular Therapies in Ovarian Cancer.
   Davis L, Miller RE, Wong YNS. · · 2023 · cited 10× · PMID 37835509 · DOI 10.3390/cancers15194814