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
1 other identifier
interventional
19
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2022
Longer than P75 for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2022
CompletedFirst Posted
Study publicly available on registry
November 15, 2022
CompletedStudy Start
First participant enrolled
November 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
ExpectedJuly 30, 2025
July 1, 2025
1.8 years
November 4, 2022
July 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of adverse events and dose limiting toxicities (DLTs)
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.
Up to 2 years post treatment
Maximal tolerated dose of AB-1015
Will be determined by a 3x3 dose escalation study
Up to 21 days
Secondary Outcomes (3)
Number of AB-1015 cells
Up to 1 year post treatment
Evidence of anti-tumor activity
Up to 2 years post treatment
Co-expression of ALPG and MSLN targets on tumor cells
Up to 2 years post treatment
Study Arms (1)
AB-1015
EXPERIMENTALPatients receive fludarabine and cyclophosphamide intravenously on days -5 to -3. Patients receive a single dose of AB-1015 intravenously on day 0.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158, United States
U of Colorado Cancer Center - Anschutz Medical Campus
Aurora, Colorado, 80045, United States
U of Iowa Health Care
Iowa City, Iowa, 52242, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
U of Washington - Fred Hutchinson Cancer Center
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Arsenal Biosciences
Arsenal Biosciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2022
First Posted
November 15, 2022
Study Start
November 29, 2022
Primary Completion
September 30, 2024
Study Completion (Estimated)
February 1, 2027
Last Updated
July 30, 2025
Record last verified: 2025-07