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AB-2100, an Integrated Circuit T (ICT) Cell Therapy in Patients With Recurrent Clear-cell Renal Cell Carcinoma (ccRCC)

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: NCT06245915
Recruitment Status : Recruiting
First Posted : February 7, 2024
Last Update Posted : May 10, 2024
Sponsor:
Information provided by (Responsible Party):
Arsenal Biosciences, Inc.

Study Description
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Brief Summary:
This is a multi-center, open-label phase 1/2 trial evaluating the safety and efficacy of AB-2100 cell product. The study may enroll approximately 60 patients in phase 1 and approximately 70 patients in phase 2.

Condition or disease Intervention/treatment Phase
Advanced/Metastatic Clear Cell Renal Cell Carcinoma Recurrence Biological: AB-2100 Phase 1 Phase 2

Detailed Description:

This study is intended for the patients who have been diagnosed with clear-cell renal cell carcinoma that either came back or did not improve after treatment with a checkpoint inhibitor and a VEGF inhibitor. The purpose of this study is to test the safety and efficacy of using a new treatment called Integrated Circuit T (ICT) cells (AB-2100 cells) in patients with renal cell carcinoma. This treatment has not been approved by the Food and Drug Administration.

The goal of this study is to determine the maximum tolerated dose of the AB-2100 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 prostate-specific membrane antigen (PSMA) and carbonic anhydrase 9 (CA9), 2 proteins found on 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-2100 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-2100 cells. If they continue to meet the eligibility criteria, AB-2100 cells will be given to them 2 days after the last conditioning chemotherapy round. A single infusion of the AB-2100 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter Phase 1/2 Study to Evaluate the Safety and Efficacy of AB-2100 in Patients With Recurrent Advanced or Metastatic Clear-cell Renal Cell Carcinoma (ccRCC)
Actual Study Start Date : February 26, 2024
Estimated Primary Completion Date : February 26, 2025
Estimated Study Completion Date : May 31, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AB-2100
Patients receive fludarabine and cyclophosphamide intravenously on days -5 to -3. Patients receive a single dose of AB-2100 intravenously on day 0.
 Biological: AB-2100
autologous T cell therapy
Other Name: Integrated Circuit T (ICT) cells


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1 (Dose escalation): incidence of adverse events [ Time Frame: From AB-2100 infusion up to 21 days post infusion ]
    Defined as dose-limiting toxicities based on a 3+3 dose escalation study design

  2. Phase 2 (Cohort expansion): Objective response rate (ORR) [ Time Frame: From AB-2100 infusion up to 24 months post-infusion ]
    ORR based on Independent Review Committee (IRC) assessment, defined as the proportion of subjects who have achieved a best overall response of CR or PR according to RECIST v1.1


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced or metastatic clear-cell renal cell carcinoma
  • Must have received an immune checkpoint inhibitor and a VEGF-targeted therapy in the advanced or metastatic setting. Must have evidence of progression on or after the last treatment regimen or discontinued treatment for unacceptable toxicity.
  • Adequate organ function as per protocol definitions.
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
  • Measurable disease at time of enrollment as per protocol definitions.
  • Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after AB-2100 infusion.

Exclusion Criteria:

  • Any prior systemic RCC therapy within 14 days of time of cell collection (interval of 28 days will be required if the last immediate treatment contained an antibody-based agent).
  • Systemic anti-cancer therapy within 14 days of starting of conditioning chemotherapy (interval of 28 days will be required if the last immediate treatment contained an antibody-based agent)
  • Investigational cellular therapies within 8 weeks prior to start of conditioning chemotherapy
  • Prior treatment with anti-CA9 therapies
  • Myocardial infarction or unstable angina within 6 months prior to screening
  • Pleural 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06245915


Contacts
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Contact: Arsenal Biosciences 650-446-4874 clinicaltrials@arsenalbio.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
United States, Iowa
University of Iowa and Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
United States, New York
Perlmutter Cancer Center - NYU Langone Health Recruiting
New York, New York, United States, 10016
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Arsenal Biosciences, Inc.
Investigators
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Study Director: Arsenal Biosciences Arsenal Biosciences
More Information
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Responsible Party: Arsenal Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT06245915    
Other Study ID Numbers: AB-2100-201
First Posted: February 7, 2024    Key Record Dates
Last Update Posted: May 10, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arsenal Biosciences, Inc.:
kidney cancer
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Adenocarcinoma
Kidney Neoplasms
 Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases