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 Details — Status: Recruiting

Administrative data

• NCT number: NCT06245915
• Other study ID #: AB-2100-201
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 26, 2024
• Est. completion date: May 31, 2027

Study information

• Verified date: May 2024
• Source: Arsenal Biosciences, Inc.
• Contact: Arsenal Biosciences
• Phone: 650-446-4874
• Email: clinicaltrials[@]arsenalbio.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: May 31, 2027
• Est. primary completion date: February 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced/Metastatic Clear Cell Renal Cell Carcinoma
• Carcinoma
• Carcinoma, Renal Cell
• Recurrence

Intervention

Biological:
• AB-2100
autologous T cell therapy

Locations

Country	Name	City	State
United States	City of Hope	Duarte	California
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Iowa and Holden Comprehensive Cancer Center	Iowa City	Iowa
United States	Perlmutter Cancer Center - NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Arsenal Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1 (Dose escalation): incidence of adverse events	Defined as dose-limiting toxicities based on a 3+3 dose escalation study design	From AB-2100 infusion up to 21 days post infusion
Primary	Phase 2 (Cohort expansion): Objective response rate (ORR)	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