Clinical trial
An Open-label Phase 1 Study to Evaluate the Safety and Efficacy of AB-1015 in Patients With Resistant/Refractory Epithelial Ovarian Cancer
Name
AB-1015-101
Description
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 arms
Trial start
2022-11-29
Estimated PCD
2024-12-01
Trial end
2027-02-01
Status
Recruiting
Phase
Early phase I
Treatment
AB-1015
autologous T cell therapy
Arms:
AB-1015
Other names:
Integrated Circuit T (ICT) cells
Size
60
Primary endpoint
Incidence of adverse events and dose limiting toxicities (DLTs)
Up to 2 years post treatment
Maximal tolerated dose of AB-1015
Up to 21 days
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-05-07
1 organization
1 product
12 indications
Organization
Arsenal BiosciencesProduct
AB-1015Indication
cancerIndication
Epithelial Ovarian CancerIndication
Ovarian CancerIndication
Fallopian Tube NeoplasmsIndication
Peritoneal NeoplasmsIndication
CancerIndication
Glandular and EpithelialIndication
Ovarian DiseasesIndication
Genitourinary cancerIndication
WomanIndication
Abdominal NeoplasmIndication
Recurrence