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

NCT06245915 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: AB-2100-201
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 9

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.

Conditions

Advanced/Metastatic Clear Cell Renal Cell Carcinoma; Recurrence

Keywords

kidney cancer; CAR T; Cell Therapy; Autologous; Autologous Cell Therapy; ccRCC; Clear Cell Renal Cell Carcinoma; AB-2100; Integrated Circuit T Cell

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

AB-2100

EXPERIMENTAL

Patients receive a single dose of AB-2100 intravenously on day 0. Patients may be assigned to receive conditioning chemotherapy prior to the infusion.

Biological: AB-2100

Interventions

AB-2100 BIOLOGICAL

autologous T cell therapy

Also known as: Integrated Circuit T cells

AB-2100

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Arsenal Biosciences, Inc.: lead

Study Sites (9)

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of Iowa and Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Dana Farber Cancer Institue

Boston, Massachusetts, 02215, United States

Location

Perlmutter Cancer Center - NYU Langone Health

New York, New York, 10016, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute - Univ of Utah Health

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Clear-cell metastatic renal cell carcinoma; Recurrence; Kidney Neoplasms; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Arsenal Biosciences

  Arsenal Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: February 26, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

US (9)