Clinical trial · Interventional
SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma
A Phase 1 Study of SynKIR-110, Autologous T Cells Transduced With Mesothelin KIR-CAR, in Subjects With Mesothelin-Expressing Advanced Ovarian Cancer, Cholangiocarcinoma, or Mesothelioma
NCT05568680CI-TRIAL-00115710recruitingPhase 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 first-in-human (FIH) trial is designed to assess the safety, feasibility, and potential activity of a single intravenous (IV) dose of SynKIR-110 administered to subjects with mesothelin-expressing advanced ovarian cancer, mesothelioma, and cholangiocarcinoma.
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 |
|---|---|---|---|
| Cholangiocarcinoma Recurrent | Ovarian Neoplasm | PROBABILISTIC | 0.70 |
| Mesothelioma, Malignant | Malignant Mesothelioma | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SynKIR-110
- description
- Single dose gravity drip IV administration
- interventionNames
- Biological: SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR
Primary outcomes (1)
- measure
- Safety and Feasibility of SynKIR-110
- timeFrame
- Up to 12 months
- description
- * The incidence, frequency, and severity of TEAEs, incidence of AEs related to native mesothelin-expressing tissues, Incidence of CRS and/or neurologic toxicity * Frequency of subjects who pass screening to enrollment but do not receive SynKIR-110
Secondary outcomes (1)
- measure
- Define the maximum tolerated dose (MTD)/maximum feasible dose (MFD) of SynKIR-110 and to identify a recommended Phase 2 dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed recurrent or relapsed advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or epithelial mesothelioma (pleural or peritoneal) after at least 1 prior line of systemic therapy for advanced disease * Adult 18 years of age or older. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Has at least 1 measurable lesion by iRECIST for ovarian cancer or cholangiocarcinoma or lesions measurable for mRECIST for mesothelioma. * Satisfactory Blood coagulation parameters * Satisfactory organ and bone marrow function Exclusion Criteria: * Active invasive cancers other than mesothelioma, cholangiocarcinoma, and ovarian unless surgically and medically cured without evidence of recurrent disease for 5 years. * History of T or B cell malignancies or previous gene-engineered T cell therapies. * Sarcomatoid/biphasic mesothelioma. * Pulmonary exclusions * Have acquired hereditary, congenital immunodeficiency or have recognized immunodeficiency disease * Active hepatitis B, active hepatitis C, or any HIV infection at the time of screening * Active autoimmune disease
References
Publications (0)
Data not yet available
No reference posted for this study.