Study on AB-2100 Cell Therapy for Patients with Recurrent Clear-cell Kidney Cancer

Sponsor: Arsenal Biosciences, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06245915

Provider View

This clinical trial is testing a new treatment called AB-2100 cell therapy for patients with clear-cell kidney cancer that has returned or not improved after previous treatments. The study aims to evaluate the safety and effectiveness of this therapy.

Patient Parameters

Program Overview

This study is exploring a new treatment for patients with clear-cell kidney cancer that has come back or not improved after treatment with certain cancer drugs. The treatment uses a special type of immune cell called Integrated Circuit T (ICT) cells, known as AB-2100 cells, to help the body's immune system target and destroy cancer cells. The study will involve about 60 patients in the first phase and 70 in the second phase to test the safety and effectiveness of this new therapy.

Description

This clinical trial is for patients with clear-cell kidney cancer that has returned or not improved after treatment with a checkpoint inhibitor and a VEGF inhibitor. The study is testing a new treatment called AB-2100 cell therapy, which is not yet approved by the FDA.

The goal is to find the safest dose of AB-2100 cells. These cells are a type of T cell, which is part of the immune system that helps fight infections and cancer. In this study, the T cells are taken from the patient and modified to recognize specific proteins on cancer cells, helping the immune system to attack the cancer while avoiding healthy cells.

Patients will receive the AB-2100 cells through an IV after undergoing three days of chemotherapy to prepare their body. If they meet the study requirements, they will receive a single infusion of the AB-2100 cells two days after the last chemotherapy session.

After treatment, patients will be monitored for safety, how well they tolerate the treatment, and how their cancer responds. This research aims to gather new information that could help future patients.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic clear-cell kidney cancer.
  • Must have previously received an immune checkpoint inhibitor and a VEGF-targeted therapy, and the cancer must have progressed or treatment was stopped due to side effects.
  • Have good organ function as defined by the study.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have measurable cancer at the time of joining the study.
  • Agree to use effective contraception during the study and for 12 months after receiving AB-2100 cells.

Exclusion Criteria

  • Have received any kidney cancer treatment within 14 days before cell collection, or 28 days if the last treatment included an antibody-based drug.
  • Have received any cancer treatment within 14 days before starting chemotherapy, or 28 days if the last treatment included an antibody-based drug.
  • Have had investigational cell therapies within 8 weeks before starting chemotherapy.
  • Have had previous treatment with anti-CA9 therapies.
  • Have had a heart attack or unstable chest pain within 6 months before screening.
  • Have fluid around the lungs that needs draining within 28 days before screening.
  • Have an active autoimmune disease requiring treatment or not controlled with treatment.
  • Have untreated cancer that has spread to the brain.
  • Are not willing to participate in extended safety monitoring.

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