Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Ovarian
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|ClinicalTrials.gov Identifier: NCT03412526|
Recruitment Status : Not yet recruiting
First Posted : January 26, 2018
Last Update Posted : January 30, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Ovarian Cancer||Drug: Fludarabine Radiation: Radiation Biological: TIL administration Drug: IL-2||Phase 2|
The Sponsor is developing the ex-vivo expanded autologous Tumor Infiltrating Lymphocytes (TIL) as the Investigational Product (IP). Yet, the administration of the TIL cellular product can only be accomplished in the context of an Autologous, Adoptive Cell Therapy (ACT) procedure which is composed of the following steps:
- Reduced Intensity, non-myeloablative, lymphodepleting induction regimen using Fludarabine (25 mg/m2 for 3 days) followed by Total Body Radiation (TBR) (2 Gray as a single treatment) for 1 day
- Preparation and administration of unselected or 4-1BB enriched TIL
- Bolus high-dose (720,000 IU/kg) IL-2 will be administered to each patient every 8 hours, to tolerance. A maximum of 10 doses will be administered per patient.
- Early-stage follow-up until 30 days post-discharge
- Late-stage follow-up, such as CT scans, will be carried out four and twelve weeks after TIL administration, and then every 3 months thereafter for the first year after TIL therapy; for the second year and onwards, as clinically indicated.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Single-Center, Open Label Study of Autologous, Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Ovarian|
|Anticipated Study Start Date :||January 31, 2018|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||February 1, 2022|
Experimental: ACT TIL
Reduced intensity, myeloablative, lymphodepleting regimen (25 mg/m2 for 3 days)Radiation: Radiation
Total Body Radiation (TBR) (2 Gray in a single treatment) for 1 dayBiological: TIL administration
TIL AdministrationDrug: IL-2
bolus high-dose (720,000 IU/kg) IL-2 is administered to the patients every 8 hours, to tolerance. A maximum of 10 doses are given to the patients.
- Objective Tumor responses [ Time Frame: 3 years ]Radiological follow up via CT to determine the sum of complete Responders (CR) + Partial Responders (PR) +Stable Disease (SD) as assessment by RECICT 1.1
- Assess adverse events using NCI CTCAE V.4.03 during treatment and follow up [ Time Frame: 3 years ]adverse events will be assess using MCI CTCAE V.4.03 during treatment and follow up
- Overall survival (OS) [ Time Frame: 3 years ]Overall survival is defined as the time from study entry until death from any cause
- Response Rate( RR) [ Time Frame: 3 years ]Radiological follow up via CT to determine the sum of complete responders (CR) + Partial responders (PR) as assessed by RECICT 1.1
- Progression Free Survival (PFS) [ Time Frame: 3 years ]Progression free survival according to RECICT 1.1
- Quality of Life (QoL) [ Time Frame: 3 years ]assessment of Quality of Life (QoL) using disease specific modules of the EORTC QLQ-C30 (version 3.0)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412526
|Contact: Jacob Scachter, Prof.||email@example.com|
|Contact: Meital Barfirstname.lastname@example.org|
|Sheba medical Center||Not yet recruiting|
|Ramat Gan, Israel, 5262100|
|Contact: Jacob Schachter, Prof. 972-3-5304907 email@example.com|
|Contact: Meital Bar 972-3-5305201 firstname.lastname@example.org|
|Principal Investigator:||Jacob Schachter, Prof.||Sheba Medical Center|