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

March 21, 2024 updated by: Arsenal Biosciences, Inc.

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 2
  • 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

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa and Holden Comprehensive 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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-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 Names:
  • Integrated Circuit T (ICT) cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From AB-2100 infusion up to 21 days post infusion
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
From AB-2100 infusion up to 24 months post-infusion

Collaborators and Investigators

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

Sponsor

Arsenal Biosciences, Inc.

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)

February 26, 2024

Primary Completion (Estimated)

February 26, 2025

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB-2100-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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