Clinical trial · Interventional
TIL Therapy for Metastatic Ovarian Cancer
T Cell Therapy for Patients With Metastatic Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Adoptive T cell therapy with tumor infiltrating lymphocytes (TIL) has achieved impressive clinical results with durable complete responses in patients with metastatic melanoma. The TILs are isolated from patients own tumor tissue followed by in vitro expansion and activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion Interleukin-2 is administered to support T cell acitivation and proliferation in vivo. Recent studies suggest, that TIL therapy works in other cancers than Metastatic Melanoma, including Ovarian Cancer. In this study TIL therapy is administered to patients with metastatic Ovarian Cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Interleukin-2 | Drug | Aldesleukin | ALIAS |
| TIL infusion | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patient group
- description
- All patients receive the same treatment. Alle patients are hospitalized during treatment (approximately 3 weeks) and receive treatment only once. Stem Cells are harvested a minimum of 3 weeks before treatment for potential later use if the patients are having difficulties recovering from the lymphodepleting chemotherapy. The patients are admitted to hospital day -8 and receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine= on day -7 to day -1. The TILs are infused on day 0 and Interleukin-2 therapy is administered on day 0 to day 5. Interleukin-2 is administered in an i.v. continous decrescendo regimen starting approximately 6 hours after TIL infusion with a duration of approximately 5 days. Stem Cells can be administered after treatment if needed.
- interventionNames
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Biological: TIL infusion
- Drug: Interleukin-2
Primary outcomes (1)
- measure
- Number and type of reported adverse events
- timeFrame
- 0-24 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed high grade serous adenokarcinoma ovarian cancer metastasis available for surgical resection (more than 1 cm3) and residual measurable disease after resection * Progression/reccurence of ovarian cancer after 1. line platin based chemotherapy or progression/reccurence after 2. line or additional chemotherapy * ECOG performance status 0-1 * Life expectancy \> 6 months * No significant toxicity from prior treatments, except sensoric- and motoric neuropathia and/or alopecia * Adequate renal, hepatic and hematological function * Women of childbearing potentil (WOCBP) must be using an effective method of contraception during treatment and for at least 6 months after completion of treatment * Able to comprehend the information given and willing to sign informed consent Exclusion Criteria: * Other malignancies, unless followed for ≥ 5 years with no sign of disease * Severe allergies, history of anaphylaxis or known allergies to the administered drugs. * Serious medical or psychiatric comorbidity * Creatinine clearance \< 70 ml/min * Acute or chronic infection with e.g. HIV, hepatitis, tuberculosis * Severe and active autoimmune disease * Pregnant and nursing women * Need for immunosuppressive treatment, e.g. corticosteroids or methotrexate * Concomitant treatment with other experimental drugs * Patients with uncontrolled hypercalcemia * Less than four weeks since prior systemic antineoplastic treatment at the time of treatment
References
Publications (2)
- DERIVEDWestergaard MCW, Andersen R, Chong C, Kjeldsen JW, Pedersen M, Friese C, Hasselager T, Lajer H, Coukos G, Bassani-Sternberg M, Donia M, Svane IM. Tumour-reactive T cell subsets in the microenvironment of ovarian cancer. Br J Cancer. 2019 Feb;120(4):424-434. doi: 10.1038/s41416-019-0384-y. Epub 2019 Feb 5. PMID 30718808
- DERIVEDAndersen R, Donia M, Westergaard MC, Pedersen M, Hansen M, Svane IM. Tumor infiltrating lymphocyte therapy for ovarian cancer and renal cell carcinoma. Hum Vaccin Immunother. 2015;11(12):2790-5. doi: 10.1080/21645515.2015.1075106. PMID 26308285