Clinical trial · Interventional
Intraperitoneal Infusion of ex Vivo-cultured Allogeneic NK Cells in Recurrent Ovarian Carcinoma Patients
Intraperitoneal Infusion of ex Vivo-cultured Allogeneic NK Cells in Recurrent Ovarian Carcinoma Patients (a Phase I Study)
NCT03539406CI-TRIAL-00079671INTROcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study investigates an innovative treatment for recurrent ovarian cancer exploiting ex vivo-generated allogeneic natural killer (NK) cells with or without preceding non-myeloablative conditioning chemotherapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Fallopian Tube Carcinoma | Fallopian Tube Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Ovarian Carcinoma | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| UCB-NK cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NK-cells without preparative regimen
- description
- NK-cells without preparative regimen
- interventionNames
- Biological: UCB-NK cells
- type
- EXPERIMENTAL
- label
- NK-cells with preparative regimen
- description
- NK-cells with preparative regimen
- interventionNames
- Biological: UCB-NK cells
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Incidence of treatment emergent adverse events
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients suffering from their second recurrence of ovarian, fallopian tube or primary peritoneal cancer, with an elevated serum level of CA-125 on two successive time points with 28 days in between, reaching a value of more than 2 times nadir and above 35 U/ml without gastrointestinal symptoms. * Able to undergo laparoscopic IP port placement and IP treatment administration * Adequate organ function * Age 18 years or older * Age under 76 years. * Karnofsky performance status \>70% (see appendix 2) * Life expectancy \> 6 months * At least 28 days after last anti cancer treatment, before start of preparative regimen * Written informed consent * Availability of a partially HLA-matched UCB unit Exclusion Criteria: * Patients on immunosuppressive drugs * Patients with active infections (viral, bacterial or fungal) that requires specific therapy. Acute anti-infectious therapy must have been completed within 14 days prior to study treatment * Laparoscopic adhesion score \>4 out of 9. * Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease (appendix 4) * Severe pulmonary dysfunction (CTCAE III-IV) (appendix 4) * Severe renal dysfunction (MDRD\<50) (appendix 4) * Severe hepatic dysfunction (serum bilirubin or transaminases \> 3 times normal level) (appendix 4) * Severe neurological or psychiatric disease
References
Publications (1)
- DERIVEDHoogstad-van Evert JS, de Jonge PKJD, Zusterzeel PLM, Hobo W, van der Waart AB, Fredrix H, Janssen L, Wuts M, Bosmans L, Spijkers E, Djojoatmo M, Rodriguez VC, de Goede AL, van der Reijden B, van der Meer A, Schaap N, Bekkers R, Jansen JH, Ottevanger N, Dolstra H. Intraperitoneal infusion of stem cell-derived natural killer cells in recurrent epithelial ovarian cancer patients: Results of the phase 1 INTRO-01 trial. Gynecol Oncol. 2026 Jan;204:91-99. doi: 10.1016/j.ygyno.2025.11.006. Epub 2025 Nov 24. PMID 41289795