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Engineered immune cells take on advanced kidney cancer in new trial

NCT ID NCT06245915

Disease control Sponsor: Arsenal Biosciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-phase trial tests a new treatment called AB-2100 for people with advanced or metastatic clear-cell renal cell carcinoma that has come back after standard treatments. AB-2100 is made from the patient's own immune cells, which are modified in the lab to better recognize and attack cancer cells. The study aims to see if this therapy is safe and whether it can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AB-2100 (a type of modified immune cell therapy called Integrated Circuit T cells)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced kidney cancer that has stopped responding to standard therapies.
What could go wrong
This is an early-phase trial with only 37 participants, so results may not apply to everyone. The therapy may cause serious side effects or fail to shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

37 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

clear cell renal carcinoma Clear-cell metastatic renal cell carcinoma kidney cancer nonpapillary renal cell carcinoma Recurrence renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced/metastatic clear cell renal cell carcinoma Recurrence

Contacts and locations

Locations

  • City of Hope

    Duarte, California, 91010, United States

  • Dana Farber Cancer Institue

    Boston, Massachusetts, 02215, United States

  • Huntsman Cancer Institute - Univ of Utah Health

    Salt Lake City, Utah, 84112, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Perlmutter Cancer Center - NYU Langone Health

    New York, New York, 10016, United States

  • University of Iowa and Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242, United States

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