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

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT07720180
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    25 mg/m2/day
  • Cyclophosphamide — DRUG
    60 mg/kg/day IV

Study Details

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.

Key Dates

First listed
Jul 22, 2026
Start date
Dec 1, 2026
Status verified
Jun 2026
Primary completion
Dec 1, 2031
Completion
Dec 1, 2032

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IL Therapy With Lymphodepletion and Consolidative Therapy
    Patients undergo tumor resection for collection of tumor-infiltrating lymphocytes (TIL), followed by lymphodepleting chemotherapy (fludarabine and cyclophosphamide), TIL infusion, and high-dose IL-2. After recovery, patients receive consolidative therapy with oral cyclophosphamide, bevacizumab, and pembrolizumab.

Primary Outcome Measure

Dose-limiting toxicity (DLT) incidence [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South Carolina Hollings Cancer CenterCharlestonSouth Carolina29425-

Find similar trials in Charleston, SC

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Medical University of South Carolina Hollings Cancer Center· Charleston, SC

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