Unresectable or Metastatic Clear Cell Renal Cell CarcinomaEarly Phase 1NCT07645690
The Safety and Efficacy of Allogeneic CD70 CAR-T Therapy in Unresectable or Metastatic Clear Cell Renal Cell Carcinoma
A Early Phase 1 study testing CLEAR CAR-T cell injection in people with Unresectable or Metastatic Clear Cell Renal Cell Carcinoma, run by Chinese PLA General Hospital at 3 sites in China.
Trial summary
CLEAR CAR-T cell injection (ET-970) is an engineered CD70-targeting allogeneic Chimeric Antigen Receptor T-Cell (CAR-T cell). This is a multi-center, single-arm, open-label, early exploratory clinical study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unresectable or Metastatic Clear Cell Renal Cell Carcinoma
- What is being tested?
- CLEAR CAR-T cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jul 2026to 31 Mar 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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).
- Coagulation function: International normalized ratio (INR) ≤ 1.5×ULN, and activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
- 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.
- Renal function: Serum creatinine ≤ 1.5×ULN or creatinine clearance (Cockcroft-Gault formula) ≥ 60 mL/min.
- Cardiac function: Left ventricular ejection fraction (LVEF) on echocardiography (ECHO) ≥ 50%, no pericardial effusion. no clinically significant abnormalities on 12-lead electrocardiogram (ECG).
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- 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).
Who cannot join
- Expected survival < 3 months.
- 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.
- Prior use of CD70-targeted therapy.
- Previous treatment with CAR-T or any other genetically engineered cell therapy.
- History of central nervous system (CNS) disease or clinically significant CNS dysfunction, such as cerebral ischemia/hemorrhage, dementia, cerebellar disease, epilepsy, aphasia, dementia, etc.
- History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
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- Occurrence of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina, or other clinically significant cardiac diseases within 12 months prior to screening.
- Presence of CNS metastasis or symptoms of CNS metastasis.
- Toxicities from prior therapy have not recovered to CTCAE grade ≤ 1, except for adverse events without safety risks (e.g., alopecia).
- The anti-tumor therapy received is still within 5 half-lives prior to the planned ET-970 infusion.
- Presence of uncontrolled active bacterial, fungal, or viral infections, or other infections deemed by the investigator as unsuitable for study participation.
- 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.
- History of other autoimmune diseases requiring immunosuppressive therapy.
- Known severe allergy to the study drug or any of its components.
- Pregnant or breastfeeding women.
- Use of any live vaccines against infectious disease within 6 weeks before lymphodepletion conditioning.
- 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.
- Psychiatric disorders with depression or suicidal tendencies.
- Presence of any other medical condition that may affect the evaluation of the safety and efficacy of the study drug.
- Other factors due to which the patient is deemed unsuitable for participation by the investigator.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Biotherapeutic Department of Chinese PLA General Hospital
Beijing
Weidong Han, Ph.D, +86-010-55499341, hanwdrsw@sina.com
Chunmeng Wang, M.S
- Recruiting
Biotherapeutic Department of Chinese PLA General Hospital
Beijing
Yang Liu, M.D., +86-010-55499341, liuyang301blood@163.com
- Recruiting
Urology Department of Chinese PLA General Hospital
Beijing
Liangyou Gu, M.D., +86-010-66936394, Guliangyouyd1@126.com
About this study
Official title: A Clinical Study to Evaluate the Safety and Efficacy of Allogeneic CD70 CAR-T Therapy in Patients With Unresectable or Metastatic Clear Cell Renal Cell Carcinoma
CLEAR CAR-T cell injection (ET-970) is an engineered CD70-targeting allogeneic Chimeric Antigen Receptor T-Cell (CAR-T cell). This is a multi-center, single-arm, open-label, early exploratory clinical study. The objective of this study is to evaluate the safety and preliminary efficacy of ET-970 in unresectable or metastatic clear cell renal cell carcinoma.
Read the detailed description
ET-970-RCC01 is an open-label study in subjects with ccRCC and will be conducted in two stages: dose-escalation (stage A) and dose-expansion (stage B). The 3+3 dose-escalation design will be adopted in stage A. The aim of stage B is to further assess the safety and efficacy of ET-970 under the dose which has been evaluated as safe in stage A. During treatment period, the subjects will receive a single-dose of ET-970. The duration of participation for each subject will be approximately 57 weeks since the signing of informed consent.
- Being tested
- CLEAR CAR-T cell injection
- Medical subject headings
- Clear-cell metastatic renal cell carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLEAR CAR-T cell injectionBiological
CLEAR CAR-T cell injection is an engineered CD70-targeting allogeneic CAR-T cell.
| Study group | Role | What they receive |
|---|---|---|
| CLEAR CAR-T cell injection | Experimental | Administered by IV infusion Receives: Biological: CLEAR CAR-T cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limited toxicity (DLT)
DLT is defined as any of the following adverse events (AEs) related to ET-970 occurring within 28 days after ET-970 infusion (CRS and ICANS will be graded according to the ASTCT 2019 criteria, and other AEs will be evaluated using CTCAE v6.0)
Measured: Within 28 days post-infusion
Incidence and severity of AEs and serious adverse events (SAEs)
AEs refer to any adverse medical events occurring in subjects from the initiation of ET-970 administration during clinical trials. SAEs denote events involving death, life-threatening conditions, significant disability/incapacity, hospitalization or prolonged hospitalization arising after ET-970 administration in subjects.
Measured: Within 52 weeks post-infusion
Incidence and severity of AESIs
AESI including grade ≥3 Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and GvHD.
Measured: Within 52 weeks post-infusion
Secondary outcomes (13)
Disease control rate (DCR)
Including complete response (CR), partial response (PR), or stable disease (SD).
Measured: Within 52 weeks post-infusion
Objective Response Rate (ORR)
Including complete response (CR), partial response (PR).
Measured: Within 52 weeks post-infusion
Duration of Response (DOR)
Time from administration to first documented PR or better.
Measured: Within 52 weeks post-infusion
Progression-Free Survival (PFS)
Time from administration to disease progression or death for any cause, whichever occurs first.
Measured: Within 52 weeks post-infusion
Overall Survival (OS)
Time from administration to death for any cause.
Measured: Within 52 weeks post-infusion
CAR-positive T cells
CAR-positive T cells in peripheral blood.
Measured: Within 52 weeks post-infusion
CAR gene copy number
CAR gene copy number in peripheral blood.
Measured: Within 52 weeks post-infusion
Number of CD70 positive cells
Number of CD70 positive cells in peripheral blood
Measured: Within 52 weeks post-infusion
Change in interleukin-2 (IL-2) levels
Peripheral blood IL-2 level changes, with measured in pg/mL.
Measured: Within 52 weeks post-infusion
Change in interleukin-6 (IL-6) levels
Peripheral blood IL-6 level changes, with measured in pg/mL.
Measured: Within 52 weeks post-infusion
Change in interleukin-10 (IL-10) levels
Peripheral blood IL-10 level changes, with measured in pg/mL.
Measured: Within 52 weeks post-infusion
Change in Tumor Necrosis Factor-α (TNF-α) levels
Peripheral blood TNF-α level changes, with measured in pg/mL.
Measured: Within 52 weeks post-infusion
Change in Interferon-gamma (IFN-γ) levels
Peripheral blood IFN-γ level changes, with measured in pg/mL.
Measured: Within 52 weeks post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable or Metastatic Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645690
- Sponsor's protocol ID
- ET-970-RCC01
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Efficacy of Allogeneic CD70 CAR-T Therapy in Patients With Unresectable or Metastatic Clear Cell Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07645690
- Acronym / sponsor ID
- ET-970-RCC01
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CLEAR CAR-T cell injection (ET-970) is an engineered CD70-targeting allogeneic Chimeric Antigen Receptor T-Cell (CAR-T cell). This is a multi-center, single-arm, open-label, early exploratory clinical study. The objective of this study is to evaluate the safety and preliminary efficacy of ET-970 in unresectable or metastatic clear cell renal cell carcinoma.
Detailed description
ET-970-RCC01 is an open-label study in subjects with ccRCC and will be conducted in two stages: dose-escalation (stage A) and dose-expansion (stage B). The 3+3 dose-escalation design will be adopted in stage A. The aim of stage B is to further assess the safety and efficacy of ET-970 under the dose which has been evaluated as safe in stage A. During treatment period, the subjects will receive a single-dose of ET-970. The duration of participation for each subject will be approximately 57 weeks since the signing of informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLEAR CAR-T cell injection | Experimental | Biological: CLEAR CAR-T cell injectionAdministered by IV infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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).
- Coagulation function: International normalized ratio (INR) ≤ 1.5×ULN, and activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
- 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.
- Renal function: Serum creatinine ≤ 1.5×ULN or creatinine clearance (Cockcroft-Gault formula) ≥ 60 mL/min.
Key exclusion criteria (20 listed)
- Expected survival < 3 months.
- 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.
- Prior use of CD70-targeted therapy.
- Previous treatment with CAR-T or any other genetically engineered cell therapy.
- History of central nervous system (CNS) disease or clinically significant CNS dysfunction, such as cerebral ischemia/hemorrhage, dementia, cerebellar disease, epilepsy, aphasia, dementia, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLEAR CAR-T cell injectionCLEAR CAR-T cell injection is an engineered CD70-targeting allogeneic CAR-T cell. | Biological | CLEAR CAR-T cell injection |
Primary outcome
Dose limited toxicity (DLT)
Time frame: Within 28 days post-infusion
DLT is defined as any of the following adverse events (AEs) related to ET-970 occurring within 28 days after ET-970 infusion (CRS and ICANS will be graded according to the ASTCT 2019 criteria, and other AEs will be evaluated using CTCAE v6.0)
Incidence and severity of AEs and serious adverse events (SAEs)
Time frame: Within 52 weeks post-infusion
AEs refer to any adverse medical events occurring in subjects from the initiation of ET-970 administration during clinical trials. SAEs denote events involving death, life-threatening conditions, significant disability/incapacity, hospitalization or prolonged hospitalization arising after ET-970 administration in subjects.
Incidence and severity of AESIs
Time frame: Within 52 weeks post-infusion
AESI including grade ≥3 Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and GvHD.
13 secondary outcomes
Disease control rate (DCR)
Time frame: Within 52 weeks post-infusion
Objective Response Rate (ORR)
Time frame: Within 52 weeks post-infusion
Duration of Response (DOR)
Time frame: Within 52 weeks post-infusion
Progression-Free Survival (PFS)
Time frame: Within 52 weeks post-infusion
Overall Survival (OS)
Time frame: Within 52 weeks post-infusion
CAR-positive T cells
Time frame: Within 52 weeks post-infusion
CAR gene copy number
Time frame: Within 52 weeks post-infusion
Number of CD70 positive cells
Time frame: Within 52 weeks post-infusion
Change in interleukin-2 (IL-2) levels
Time frame: Within 52 weeks post-infusion
Change in interleukin-6 (IL-6) levels
Time frame: Within 52 weeks post-infusion
Change in interleukin-10 (IL-10) levels
Time frame: Within 52 weeks post-infusion
Change in Tumor Necrosis Factor-α (TNF-α) levels
Time frame: Within 52 weeks post-infusion
Change in Interferon-gamma (IFN-γ) levels
Time frame: Within 52 weeks post-infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, China
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, China
Urology Department of Chinese PLA General Hospital
Beijing, China
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CLEAR CAR-T cell injection in people with Unresectable or Metastatic Clear Cell Renal Cell Carcinoma, run by Chinese PLA General Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limited toxicity (DLT) (time frame: Within 28 days post-infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.