Experimental cell therapy takes aim at Hard-to-Treat kidney cancer
NCT ID NCT07500805
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study tests a new cell therapy called UCL70805F in 21 people with advanced clear cell kidney cancer that has not responded to standard treatments. The therapy uses immune cells designed to target a protein called CD70 on cancer cells. The main goals are to check safety and see if the treatment 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
- UCL70805F (a type of cell therapy using immune cells to target CD70 on cancer cells)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced kidney cancer that has stopped responding to standard therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 21 participants, so it is primarily testing safety. The treatment may not shrink tumors or could cause serious side effects.
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 21 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2029
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 75 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.
Show the full entry requirements Hide 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: * Age from 18 to 75 years old (inclusive), gender is not limited. * Histopathologically confirmed advanced clear cell renal cell carcinoma (ccRCC) that has failed prior standard therapy, or is intolerant to standard therapy, or for which no effective treatment is available. * At least one measurable target lesion as defined by RECIST v1.1. * Fresh solid tumor samples or formalin fixed paraffin embedded tumor archival samples are necessary. * CD70 should be positive confirmed by Immunohistochemistry (IHC) in tumor tissue samples (H-Score \> 100 for CD70 membrane expression). * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Life expectancy ≥ 3 months. * The organ function must meet the protocol requirements. * Female participants of childbearing potential must have a negative pregnancy test. Female participants of childbearing potential or male participants have partners of childbearing potential must agree to use effective contraception throughout the screening period until 1 year after the last cell infusion. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * Pregnant or lactating women. * Hepatitis C virus (HCV) antibody positive with quantitative PCR for peripheral blood HCV RNA above the lower limit of detection; human immunodeficiency virus (HIV) antibody positive; or active syphilis infection. * HBV surface antigen (HBsAg) positive and/or HBV core antibody (HBcAb) positive, with HBV-DNA ≥ 500 IU/mL. * Unresolved \> Grade 1 non-hematologic toxicity per CTCAE 5.0 associated with any prior treatments (surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.), except for alopecia, peripheral sensory neuropathy. * History of allogeneic tissue/organ transplantation (including bone marrow transplantation, stem cell transplantation, liver transplantation, kidney transplantation, etc.), except for transplants not requiring immunosuppressive therapy (e.g., corneal transplantation, hair transplantation). * Receipt of other CD70-targeted CAR-T cell therapy. * Major surgery procedure without full recovery within 4 weeks prior to signing the informed consent, or a history of severe trauma that have not recovered, or plan to receive major surgery procedure within 12 weeks after cell infusion. * Known central nervous system metastasis lesions, except for the following participants: a. asymptomatic brain metastases; b. clinically stable status (i.e., no radiological progression within 4 weeks prior to cell apheresis, and any neurological symptoms have resolved to baseline level), and have not required corticosteroids or other therapy for brain metastases for ≥ 4 weeks. * Presence of clinically significant systemic disease (e.g., severe active infection or significant dysfunctions of the heart, lungs, liver, nervous system, or other organs), at the discretion of the Investigator, impairs the participant's ability to tolerate the treatment specified in this trial protocol or significantly increases the risk of complications. * History of severe systemic hypersensitivity to the drugs/components used in this trial \[e.g., fludarabine, cyclophosphamide, dimethyl sulfoxide (DMSO), low molecular weight dextran, human serum albumin (HSA)\]. * Receipt of live attenuated vaccine within 4 weeks prior to signing informed consent. * Participation in another clinical trial within 4 weeks prior to signing informed consent. * History of another malignancy within the past 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ (e.g., breast, stomach, colon, cervix, etc.). * History of neuropsychiatric disorders diagnosed per ICD-11 criteria, or any neuropsychiatric disorder requiring exclusion as determined by the investigator, including but not limited to epilepsy, schizophrenia, dementia, or drugs/alcohol addiction. * Any other condition that, in the investigator's opinion, makes the patient unsuitable for participating in this trial.
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Get notified about this study
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China