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New cell therapy takes on advanced kidney cancer

NCT ID NCT04696731

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This early-stage study tests a new treatment called ALLO-316 for people with advanced or spreading clear cell kidney cancer who have already tried standard therapies like checkpoint inhibitors and VEGF inhibitors. The treatment uses specially designed immune cells from a donor to attack the cancer, given after a short chemotherapy course to prepare the body. The main goals are to find the safest dose and see if it helps control the disease.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2021

Expected to finish

Jan 2030

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 to 74 years

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: * Histologically confirmed renal cell carcinoma with a predominant clear cell component. * Must have received a checkpoint inhibitor and a VEGF inhibitor in the advanced and/or metastatic setting. * At least one measurable lesion as defined by RECIST version 1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. * Absence of donor (product)-specific anti-HLA antibodies (DSA). * Adequate hematological, renal, liver, pulmonary, and cardiac functions. Exclusion Criteria: * Central nervous system (CNS) metastatic disease (unless controlled and stable for at least 4 weeks), leptomeningeal disease, or cord compression. * Clinically significant CNS dysfunction. * Any other active malignancy within 3 years prior to enrollment. * Prior treatment with anti-CD70 therapies. * Current thyroid disorder (including hyperthyroidism) with the exception of hypothyroidism controlled on stable dose of hormone replacement therapy. * Prior treatment with anti-CD52 monoclonal antibody in the past 12 months. * Participants unwilling to participate in the extended safety monitoring period.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • City of Hope

    Duarte, California, 91010, United States

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • UCLA Medical Center

    Los Angeles, California, 90095, United States

  • UCSF Medical Center

    San Francisco, California, 94143, United States

  • Yale School of Medicine

    New Haven, Connecticut, 06520, United States

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