Metastatic Ovarian Cancer Clinical Trial
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
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.
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:
1. 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
2. Preparation and administration of unselected or 4-1BB enriched TIL
3. 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.
4. Early-stage follow-up until 30 days post-discharge
5. 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.
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