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

Recurrence Clinical Trial

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)

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06245915
Study type Interventional
Source Arsenal Biosciences, Inc.
Contact Arsenal Biosciences
Phone 650-446-4874
Email clinicaltrials@arsenalbio.com
Status Recruiting
Phase Phase 1/Phase 2
Start date February 26, 2024
Completion date May 31, 2027
View Details
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