NCT06245915

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

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)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Arsenal Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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 as a single intravenous infusion. Patients may be assigned to receive conditioning chemotherapy prior to the infusion 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.

Conditions

• Advanced/Metastatic Clear Cell Renal Cell Carcinoma
• Recurrence

Interventions

Type	Name	Description
BIOLOGICAL	AB-2100	autologous T cell therapy

Timeline

• Start date: 2024-02-26
• Primary completion: 2026-03-31
• Completion: 2028-06-30
• First posted: 2024-02-07
• Last updated: 2025-09-22

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study