Carcinoma, Ovarian EpithelialPhase 1NCT05617755
AB-1015, an Integrated Circuit T (ICT) Cell Therapy in Patients With Platinum Resistant Epithelial Ovarian Cancer
A Phase 1 study testing AB-1015 in people with Carcinoma, Ovarian Epithelial and Ovarian Neoplasms, run by Arsenal Biosciences, Inc. at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Carcinoma, Ovarian Epithelial, Ovarian Neoplasms, Fallopian Tube Neoplasms
- What is being tested?
- AB-1015
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 8 sitesUnited States
- Study dates
- 29 Nov 2022to Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
U of Colorado Cancer Center - Anschutz Medical Campus
Aurora, Colorado, 80045
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
MD Anderson Cancer Center
Houston, Texas, 77030
U of Iowa Health Care
Iowa City, Iowa, 52242
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
U of Washington - Fred Hutchinson Cancer Center
Seattle, Washington, 98195
About this study
Official title: An Open-label Phase 1 Study to Evaluate the Safety and Efficacy of AB-1015 in Patients With Resistant/Refractory Epithelial Ovarian Cancer
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.
Read the 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.
- Conditions
- Carcinoma, Ovarian Epithelial, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Neoplasms, Glandular and Epithelial, Ovarian Diseases
- Being tested
- AB-1015
- Keywords
- ovarian cancer, fallopian tube cancer, primary peritoneal cancer, platinum resistant
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Neoplasms, Glandular and Epithelial, Ovarian Diseases, Genital Neoplasms, Female, Abdominal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-1015Biological
Also called Integrated Circuit T (ICT) cells
autologous T cell therapy
| Study group | Role | What they receive |
|---|---|---|
| AB-1015 | Experimental | Patients receive fludarabine and cyclophosphamide intravenously on days -5 to -3. Patients receive a single dose of AB-1015 intravenously on day 0. Receives: Biological: AB-1015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years post treatment
Maximal tolerated dose of AB-1015
Will be determined by a 3x3 dose escalation study
Measured: Up to 21 days
Secondary outcomes (3)
Number of AB-1015 cells
Number of AB-1015 cells present in patients treatment with AB-1015
Measured: Up to 1 year post treatment
Evidence of anti-tumor activity
Assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: Up to 2 years post treatment
Co-expression of ALPG and MSLN targets on tumor cells
Assessment by immunohistochemistry (or similar method)
Measured: Up to 2 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start29 Nov 2022
- Primary completion30 Sep 2024
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Ovarian EpithelialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arsenal Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arsenal Biosciences, Study director, Arsenal Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617755
- Sponsor's protocol ID
- AB-1015-101
- Status last verified
- Sep 2026
- First submitted
- 4 Nov 2022
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase 1 Study to Evaluate the Safety and Efficacy of AB-1015 in Patients With Resistant/Refractory Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05617755
- Acronym / sponsor ID
- AB-1015-101
- Conditions
- Carcinoma, Ovarian Epithelial, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Neoplasms, Glandular and Epithelial, Ovarian Diseases
- Keywords
- ovarian cancer, fallopian tube cancer, primary peritoneal cancer, platinum resistant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Arsenal Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AB-1015 | Experimental | Biological: AB-1015Patients receive fludarabine and cyclophosphamide intravenously on days -5 to -3. Patients receive a single dose of AB-1015 intravenously on day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AB-1015Also: Integrated Circuit T (ICT) cellsautologous T cell therapy | Biological | AB-1015 |
Primary outcome
Incidence of adverse events and dose limiting toxicities (DLTs)
Time frame: Up to 2 years post treatment
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.
Maximal tolerated dose of AB-1015
Time frame: Up to 21 days
Will be determined by a 3x3 dose escalation study
3 secondary outcomes
Number of AB-1015 cells
Time frame: Up to 1 year post treatment
Evidence of anti-tumor activity
Time frame: Up to 2 years post treatment
Co-expression of ALPG and MSLN targets on tumor cells
Time frame: Up to 2 years post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arsenal Biosciences study director
Arsenal Biosciences
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AB-1015 in people with Carcinoma, Ovarian Epithelial and Ovarian Neoplasms, run by Arsenal Biosciences, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events and dose limiting toxicities (DLTs) (time frame: Up to 2 years post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.