🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT06245915
Active, not recruiting Phase 1/2

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

NCT06245915 · tracked via the Priya Life Science USA tracker
Sponsor
Arsenal Biosciences, Inc.
Phase
Phase 1/2
Started
2024-02-26
Last updated
2025-09-22

Condition(s) studied

Advanced/Metastatic Clear Cell Renal Cell CarcinomaRecurrence

Investigational drug(s) / intervention(s)

AB-2100

AB-2100: autologous T cell therapy

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Mayo Clinic Hospital Phoenix Arizona
City of Hope Duarte California
Moffitt Cancer Center Tampa Florida
University of Iowa and Holden Comprehensive Cancer Center Iowa City Iowa
Dana Farber Cancer Institue Boston Massachusetts
Perlmutter Cancer Center - NYU Langone Health New York New York
Memorial Sloan Kettering Cancer Center New York New York
MD Anderson Cancer Center Houston Texas
Huntsman Cancer Institute - Univ of Utah Health Salt Lake City Utah

More Arsenal Biosciences, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06245915 on ClinicalTrials.gov ↗ ← All trials in the USA