Study of Autologous, Metabolically Optimized, CD137+ Tumor-Infiltrating Lymphocytes Followed by Consolidative Oral Cyclophosphamide, Bevacizumab, and Pembrolizumab

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorMedical University of South Carolina

About this trial

Patients with recurrent ovarian cancer will undergo resection of a safely accessible metastatic lesion, from which tumor-infiltrating lymphocytes (TIL) will be cultured, metabolically reprogrammed for metabolic fit T cells, then selected for CD137+ activated T cells, and then expanded. This expanded TIL product will be infused following nonmyeloablative lymphodepletion chemotherapy. High-dose IL-2 will be given after TIL infusion to support the cell product expansion. Once recovered from TIL infusion, patients will start consolidative systemic therapy with oral cyclophosphamide, bevacizumab, and pembrolizumab.

Eligibility criteria

Qualifiers

Provision of signed and dated informed consent form.

Stated willingness to comply with all study procedures and availability for the duration of the study.

Female, aged 18 to 80 years.

Patients must have recurrent epithelial ovarian cancer, all subtypes will be eligible.

Disqualifiers

Patients with active systemic infections requiring intravenous antibiotics, coagulation disorders, or other major medical illnesses of the cardiovascular, respiratory, or immune system.

Frontline platinum refractory patients (progression on or <90 days from last platinum dose)

Patients that have completed an adoptive cellular therapy regimen which included a non-myeloablative lymphodepletion strategy. Prior Bi-specific T-cell engagers are allowed if done without lymphodepletion and no grade 3 CRS/ICANs events were experienced.

Patients testing positive for HIV titer, hepatitis B surface antigen, human T-cell leukemia-lymphoma virus (HTLV) I or II antibody, or both rapid plasma regain (RPR) and fluorescent treponemal antibody (FTA). Patients with hepatitis C antibody must have a negative (undetectable) viral load by polymerase chain reaction (PCR).

Trial design

Treatments tested in this trial

  • Fludarabine
  • Cyclophosphamide

Treatment groups

20 Participants
are divided into 1 treatment group