Clinical Trial

Disease: Renal Cell Carcinoma, RCC, (NCT06245915)

Disease info:

Renal cell cancer (also called kidney cancer or renal cell adenocarcinoma) is a disease in which malignant (cancer) cells are found in the lining of tubules (very small tubes) in the kidney. There are 2 kidneys, one on each side of the backbone, above the waist. Tiny tubules in the kidneys filter and clean the blood. 

Cancer that starts in the ureters or the renal pelvis (the part of the kidney that collects urine and drains it to the ureters) is different from renal cell cancer. 

The prognosis and treatment options depend on the stage of the disease, and the patient's age and general health. After renal cell cancer has been diagnosed, tests are done to find out if cancer cells have spread within the kidney or to other parts of the body. The cancer may come back in the kidney or in other parts of the body after initial treatment.

There are different types of treatment for patients with renal cell cancer. Five types of standard treatment are used:

Surgery
Radiation therapy
Chemotherapy
Immunotherapy
Targeted therapy
New types of treatment are being tested in clinical trials. Patients can enter clinical trials before, during, or after starting their cancer treatment. Follow-up tests may be needed.

 

Frequency:
The American Cancer Society estimates about 81,800 new cases of kidney cancer will be diagnosed in the United States in 2023, and approximately 14,890 will die from the disease..
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)
Who:

Contact

Arsenal Biosciences

Phone: 650-446-4874

Email: clinicaltrials@arsenalbio.com

Sponsor:

Arsenal Biosciences, Inc.

Partners:
Locations:

United States, California
City of Hope, Duarte, California, United States, 91010

Study start:
Feb. 26, 2024
Enrollment:
130 participants
Gene editing method:
CITE (CRISPR Integration of Transgene via Electroporation)
Type of edit:
Gene insertion
Gene:
Circuit/logic gate inserted to make cells able to recognise prostate-specific membrane antigen (PSMA) and carbonic anhydrase 9 (CA9)
Delivery method:
Electroporation - Ex-vivo
Trial link:
https://clinicaltrials.gov/study/NCT06245915?spons=Arsenal%20Biosciences,%20Inc.#contacts-and-locations
IndicatorIndicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Not yet recruiting

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.

Last updated: Feb. 13, 2024
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