Trial Title:
AB-1015, an Integrated Circuit T (ICT) Cell Therapy in Patients with Platinum Resistant Epithelial Ovarian Cancer
NCT ID:
NCT05617755
Condition:
Carcinoma, Ovarian Epithelial
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Diseases
Genital Neoplasm, Female
Abdominal Neoplasm
Recurrence
Conditions: Official terms:
Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Fallopian Tube Neoplasms
Genital Neoplasms, Female
Abdominal Neoplasms
Ovarian Diseases
Recurrence
Conditions: Keywords:
ovarian cancer
fallopian tube cancer
primary peritoneal cancer
platinum resistant
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
AB-1015
Description:
autologous T cell therapy
Arm group label:
AB-1015
Other name:
Integrated Circuit T (ICT) cells
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.
Detailed description:
This study is intended for the patients who have been diagnosed with Epithelial Ovarian
Cancer that either came back or did not improve after platinum treatments (platinum
resistant). The purpose of this study is to test the safety of using a new treatment
called Integrated Circuit T (ICT) cells (AB-1015 cells) in patients with ovarian cancer.
This treatment has not been approved by the Food and Drug Administration.
The goal of this study is to calculate the maximum tolerated dose of the AB-1015 cells. T
cells are part of the immune system that protect the body from infection and may help
fight cancer. The T cells given in this study will come from the patient and will have a
genetic circuit/logic gate put in them that makes them able to recognize alkaline
phosphatase, germ line/placental (ALPG/P) and mesothelin (MSLN), 2 proteins on the
surface of tumor cells. These logic-gated T cells may help the body's immune system
identify and kill cancer cells while sparing normal healthy tissues from toxicity.
The AB-1015 cells are given intravenously, after completing 3 rounds of conditioning
chemotherapy administered over 3 consecutive days. Conditioning chemotherapy prepares the
body to receive the AB-1015 cells. If they continue to meet the eligibility criteria,
AB-1015 cells will be given to them 2 days after the last conditioning chemotherapy
round. A single infusion of the AB-1015 cells will be given to the subject intravenously.
After completion of study treatment, patients are followed with serial measurements of
safety, tolerability and response.
This is a research study to obtain new information that may help people in the future.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCSF Helen Diller Family Comprehensive Cancer Center
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Facility:
Name:
U of Colorado Cancer Center - Anschutz Medical Campus
Address:
City:
Aurora
Zip:
80045
Country:
United States
Facility:
Name:
U of Chicago Comprehensive Cancer Center
Address:
City:
Chicago
Zip:
60637
Country:
United States
Facility:
Name:
U of Iowa Health Care
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Facility:
Name:
Barbara Ann Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Facility:
Name:
Roswell Park Comprehensive Cancer Center
Address:
City:
Buffalo
Zip:
14203
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Facility:
Name:
U of Oklahoma, Stephenson Cancer Center
Address:
City:
Oklahoma City
Zip:
73117
Country:
United States
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
U of Washington - Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98195
Country:
United States
Start date:
November 29, 2022
Completion date:
February 2027
Lead sponsor:
Agency:
Arsenal Biosciences, Inc.
Agency class:
Industry
Source:
Arsenal Biosciences, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05617755
