Clinical trial · Interventional
AB-1015, an Integrated Circuit T (ICT) Cell Therapy in Patients With Platinum Resistant Epithelial Ovarian Cancer
An Open-label Phase 1 Study to Evaluate the Safety and Efficacy of AB-1015 in Patients With Resistant/Refractory Epithelial Ovarian Cancer
NCT05617755CI-TRIAL-00125597active not recruitingPhase 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 is a multi-center, open-label phase 1 dose escalation trial that uses a modified 3+3 design to identify a recommended phase 2 dose (RP2D) of AB-1015 cell product. Backfill cohorts will enroll additional subjects at doses deemed to be safe for a total enrollment of up to 12 subjects per each backfill cohort on the protocol.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Neoplasm | — | UNRESOLVED | — |
| Carcinoma, Ovarian Epithelial | Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Fallopian Tube Neoplasms | Fallopian Tube Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Genital Neoplasm, Female | Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Neoplasms, Glandular and Epithelial | Neoplasm | ONTOLOGY_EXACT | 0.85 |
| Ovarian Diseases | — | UNRESOLVED | — |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Peritoneal Neoplasms | Peritoneal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AB-1015 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AB-1015
- description
- Patients receive fludarabine and cyclophosphamide intravenously on days -5 to -3. Patients receive a single dose of AB-1015 intravenously on day 0.
- interventionNames
- Biological: AB-1015
Primary outcomes (2)
- measure
- Incidence of adverse events and dose limiting toxicities (DLTs)
- timeFrame
- Up to 2 years post treatment
- description
- Toxicity grading will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5.0 and monitoring of adverse events. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) events will be graded according to the criteria outlined in the protocol.
- measure
- Maximal tolerated dose of AB-1015
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Recurrent, advanced, platinum resistant ovarian, fallopian tube, and primary peritoneal cancer and must have a histological diagnosis of a high-grade serous histology. * a) Platinum resistant disease is defined as progression of disease within six months of platinum regimen. * Doubling of cancer antigen 125 (CA-125) level on 2 successive measurements may be considered as meeting the definition of disease progression * b) Have received at least 2 lines of prior therapy including a platinum-based regimen if eligible and a poly-ADP ribose polymerase (PARP) inhibitor if BRCA1/2 mutated. No more than 3 lines of prior therapy for the treatment of platinum resistant disease is permitted. * Adequate organ function as per protocol definitions. * Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1. * Evaluable disease (dose escalation cohorts) or measurable disease (backfill cohorts) at time of enrollment as per protocol definitions. * Negative pregnancy test for women of childbearing potential. Women of non-childbearing potential are those who have been surgically sterilized, have medically confirmed ovarian failure, or have not had menses within the past 12 months. Exclusion Criteria: * Cytotoxic chemotherapy within 14 days of time of cell collection. * Cytotoxic chemotherapy within 14 days of starting of conditioning chemotherapy. * New York Heart Association functional class II-IV cardiovascular disability * Clinically significant pericardial effusion * Pleural or peritoneal effusion that requires drainage for symptom management within 28 days of screening. * Active autoimmune disease requiring immunosuppressive therapy or uncontrolled with treatment. * Untreated brain metastasis. * Subjects unwilling to participate in an extended safety monitoring period.
References
Publications (0)
Data not yet available
No reference posted for this study.