New cell therapy takes on advanced kidney cancer
NCT ID NCT04696731
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2021
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 74 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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City of Hope
Duarte, California, 91010, United States
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Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
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Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Providence Portland Medical Center
Portland, Oregon, 97213, United States
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UCLA Medical Center
Los Angeles, California, 90095, United States
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UCSF Medical Center
San Francisco, California, 94143, United States
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Yale School of Medicine
New Haven, Connecticut, 06520, United States
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