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AB-1015, an Integrated Circuit T (ICT) Cell Therapy in Patients With Platinum Resistant Epithelial Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05617755
Recruitment Status : Recruiting
First Posted : November 15, 2022
Last Update Posted : February 8, 2023
Information provided by (Responsible Party):
Arsenal Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE November 4, 2022
First Posted Date  ICMJE November 15, 2022
Last Update Posted Date February 8, 2023
Actual Study Start Date  ICMJE November 29, 2022
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2022)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2022)
  • Number of AB-1015 cells [ Time Frame: Up to 1 year post treatment ]
    Number of AB-1015 cells present in patients treatment with AB-1015
  • Evidence of anti-tumor activity [ Time Frame: Up to 2 years post treatment ]
    Assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Co-expression of ALPG and MSLN targets on tumor cells [ Time Frame: Up to 2 years post treatment ]
    Assessment by immunohistochemistry (or similar method)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE AB-1015, an Integrated Circuit T (ICT) Cell Therapy in Patients With Platinum Resistant Epithelial Ovarian Cancer
Official Title  ICMJE An Open-label Phase 1 Study to Evaluate the Safety and Efficacy of AB-1015 in Patients With Resistant/Refractory Epithelial Ovarian Cancer
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Carcinoma, Ovarian Epithelial
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Diseases
  • Genital Neoplasm, Female
  • Abdominal Neoplasm
  • Recurrence
Intervention  ICMJE Biological: AB-1015
autologous T cell therapy
Other Name: Integrated Circuit T (ICT) cells
Study Arms  ICMJE Experimental: AB-1015
Patients receive fludarabine and cyclophosphamide intravenously on days -5 to -3. Patients receive a single dose of AB-1015 intravenously on day 0.
Intervention: Biological: AB-1015
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 10, 2022)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2027
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 cannot be treated with standard approaches.
  • Active autoimmune disease requiring immunosuppressive therapy or uncontrolled with treatment.
  • Untreated brain metastasis.
  • Subjects unwilling to participate in an extended safety monitoring period.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Arsenal Biosciences 650-212-5368 clinicaltrials@arsenalbio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT05617755
Other Study ID Numbers  ICMJE AB-1015-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Arsenal Biosciences, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Arsenal Biosciences, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Arsenal Biosciences Arsenal Biosciences
PRS Account Arsenal Biosciences, Inc.
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP