Engineered immune cells take on Hard-to-Treat kidney cancer
NCT ID NCT07645690
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial is testing a new type of immune cell therapy called CLEAR CAR-T (ET-970) in 30 people with advanced clear cell kidney cancer that has not responded to at least two prior treatments. The therapy uses donor immune cells engineered 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
- CLEAR CAR-T cell injection (ET-970) - an engineered immune cell therapy targeting CD70
- 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, small trial (30 people) focused on safety. The therapy may not shrink tumors or could cause serious side effects like cytokine release syndrome.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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.
Key Inclusion Criteria: 1.Age 18-75 years (inclusive), any gender. 2.Confirmed by histopathology and/or cytology as unresectable or metastatic clear cell renal cell carcinoma; 3.Local progression or metastasis after receiving at least second line therapy \[including at least one immune checkpoint inhibitor (ICI) and at least one vascular endothelial growth factor tyrosine kinase inhibitor (VEGF TKI)\]; 4.Willing to undergo tumor tissue sample collection or provide previous tumor tissue samples for CD70 expression level testing; 5.Positive CD70 expression by immunohistochemical (IHC) staining of tumor tissue (percentage of positive cells ≥ 10%); 6.At least one measurable lesion according to RECIST v1.1 criteria. 7.Karnofsky Performance Status (KPS) ≥ 70%. 8.Organ function must meet the following criteria: 1. Complete blood count (no G-CSF within 1 week prior to blood count testing. or no pegylated G-CSF within 2 weeks prior to blood count testing): Absolute neutrophil count (ANC) ≥ 1.0×10⁹/L. platelet count (PLT) ≥ 100×10⁹/L. hemoglobin ≥ 80 g/L (excluding bone marrow suppression caused by lymphoma involvement of the bone marrow). 2. Coagulation function: International normalized ratio (INR) ≤ 1.5×ULN, and activated partial thromboplastin time (APTT) ≤ 1.5×ULN. 3. Liver function: Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3×ULN (if with liver metastasis, AST and ALT ≤ 5×ULN). total bilirubin ≤ 1.5×ULN. 4. Renal function: Serum creatinine ≤ 1.5×ULN or creatinine clearance (Cockcroft-Gault formula) ≥ 60 mL/min. 5. Cardiac function: Left ventricular ejection fraction (LVEF) on echocardiography (ECHO) ≥ 50%, no pericardial effusion. no clinically significant abnormalities on 12-lead electrocardiogram (ECG). 6. Pulmonary function: End-blood oxygen saturation ≥ 92% while breathing room air without supplemental oxygen. no clinically significant pleural effusion. 9.Subjects and/or their partners of childbearing potential agree to use effective contraceptive measures throughout the entire treatment period and for 52 weeks after treatment, and during this period they must not donate eggs/sperm for assisted reproduction; Female participants of childbearing potential (women who have undergone sterilization surgery or have been postmenopausal for ≥12 months are not considered to have childbearing potential) must present a negative pregnancy test at screening and agree to use effective contraception throughout the study period. 10.Willing to comply with all study procedures and voluntarily participate in this study and sign the informed consent form (ICF). Key Exclusion Criteria: 1. Expected survival \< 3 months. 2. Prior or concurrent active malignancy, with the exception of cured or recurrence-free for at least 3 years of cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer, or locally advanced prostate cancer that has received curative treatment, or ductal carcinoma in situ after radical surgery. 3. Prior use of CD70-targeted therapy. 4. Previous treatment with CAR-T or any other genetically engineered cell therapy. 5. History of central nervous system (CNS) disease or clinically significant CNS dysfunction, such as cerebral ischemia/hemorrhage, dementia, cerebellar disease, epilepsy, aphasia, dementia, etc. 6. History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation. 7. Occurrence of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina, or other clinically significant cardiac diseases within 12 months prior to screening. 8. Presence of CNS metastasis or symptoms of CNS metastasis. 9. Toxicities from prior therapy have not recovered to CTCAE grade ≤ 1, except for adverse events without safety risks (e.g., alopecia). 10. The anti-tumor therapy received is still within 5 half-lives prior to the planned ET-970 infusion. 11. Presence of uncontrolled active bacterial, fungal, or viral infections, or other infections deemed by the investigator as unsuitable for study participation. 12. Positive for human immunodeficiency virus (HIV) antibody, positive for Treponema pallidum antibody, positive for hepatitis B surface antigen (HBsAg) or positive for hepatitis B core antibody (HBcAb) with detectable peripheral blood HBV DNA, positive for hepatitis C virus (HCV) antibody with detectable HCV RNA; except for infections that can be prevented or controlled with medication as judged by the investigator. 13. History of other autoimmune diseases requiring immunosuppressive therapy. 14. Known severe allergy to the study drug or any of its components. 15. Pregnant or breastfeeding women. 16. Use of any live vaccines against infectious disease within 6 weeks before lymphodepletion conditioning. 17. Participation in another interventional clinical study and receipt of an active investigational drug within 3 months prior to signing the ICF, or intention to participate in another clinical trial or receive treatment for autoimmune diseases outside the protocol during the entire study period. 18. Psychiatric disorders with depression or suicidal tendencies. 19. Presence of any other medical condition that may affect the evaluation of the safety and efficacy of the study drug. 20. Other factors due to which the patient is deemed unsuitable for participation by the investigator.
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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
3 sites. 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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Biotherapeutic Department of Chinese PLA General Hospital
RECRUITINGBeijing, China
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Biotherapeutic Department of Chinese PLA General Hospital
RECRUITINGBeijing, China
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Urology Department of Chinese PLA General Hospital
RECRUITINGBeijing, China