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

January 4, 2024 updated by: Arsenal Biosciences, Inc.

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.

Study Overview

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

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Helen Diller Family Comprehensive Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • U of Colorado Cancer Center - Anschutz Medical Campus
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • U of Chicago Comprehensive Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • U of Iowa Health Care
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Barbara Ann Karmanos Cancer Institute
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Roswell Park Comprehensive Cancer Center
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73117
        • Recruiting
        • U of Oklahoma, Stephenson Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • U of Washington - Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
autologous T cell therapy
Other Names:
  • Integrated Circuit T (ICT) cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 2 years post treatment
Maximal tolerated dose of AB-1015
Time Frame: Up to 21 days
Will be determined by a 3x3 dose escalation study
Up to 21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 1 year post treatment
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
Up to 2 years post treatment
Co-expression of ALPG and MSLN targets on tumor cells
Time Frame: Up to 2 years post treatment
Assessment by immunohistochemistry (or similar method)
Up to 2 years post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Arsenal Biosciences, Arsenal Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2022

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

November 4, 2022

First Submitted That Met QC Criteria

November 10, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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