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

Introduction

• Org Study ID: AB-2100-201
• NTC ID: NCT06245915
• Lead Sponsor Name: Arsenal Biosciences, Inc.
• Status: RECRUITING

Conditions

• Clear Cell Renal Cell Carcinoma

Brief 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.

Eligibility Criteria

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.