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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Advanced/Metastatic Clear Cell Renal Cell Carcinoma, Recurrence

In brief

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.

Key facts

Study ID

NCT06245915

Run by

Arsenal Biosciences, Inc.

People needed

37

Starts

2024-02-26

Expected to finish

2028-06-30

Last updated by the study team

2025-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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