Advanced Renal Cell CarcinomaEarly Phase 1NCT07113977
Clinical Study of a Novel Humanized CD70-Targeted CAR-T Cell Incorporating TLR2 for Advanced Renal Cell Carcinoma Therapy
A Early Phase 1 study testing CAR-T(CD70) in people with Advanced Renal Cell Carcinoma, run by Wei Guan.
Trial summary
In this clinical study, participants with advanced renal cell carcinoma will receive a novel humanized CD70-targeted CAR-T-cell product that incorporates the TLR2 co-stimulatory domain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Renal Cell Carcinoma
- What is being tested?
- CAR-T(CD70)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 31 Dec 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. Voluntary participation with written informed consent provided by the patient or legally authorized representative;
- 2.Age 18-75 years (inclusive) at the time of consent, regardless of sex;
- 3.Advanced-stage renal cell carcinoma (RCC) with no curative treatment options, who have received ≥1 prior line of therapy and meet one or more of the following:
- Recurrence after first-line or later-line treatment(s).
- Progression or persistent progression following prior therapy;
- 4.Histopathologically confirmed advanced RCC per WHO 2016 classification, with at least one measurable lesion evaluable by CT or MRI;
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- 5.CD70 positivity in tumor tissue confirmed by immunohistochemistry (IHC);
- 6.Adequate organ function: Hepatic: ALT/AST <3× ULN and total bilirubin ≤34.2 μmol/L. Renal: Creatinine clearance (Cockcroft-Gault) ≥60 mL/min. Pulmonary: Oxygen saturation ≥95% with no active pulmonary infection. Cardiac: LVEF ≥50%, no significant pericardial effusion, and no clinically relevant ECG abnormalities;
- 7.Contraception: Women of childbearing potential must have a negative pregnancy test (urine/serum) at screening and agree to use effective contraception for ≥1 year post-infusion.
- Men with partners of childbearing potential must use barrier contraception for ≥1 year post-infusion;
- 8.Performance status: ECOG score 0-3;
- 9.Life expectancy >3 months;
- 10.Willingness to comply with leukapheresis, medical assessments, and follow-up visits.
Who cannot join
- 1.Pregnant or lactating women;
- 2.Uncontrolled fungal, bacterial, Treponema pallidum, viral, or other infections;
- 3.Active hepatitis: HBV DNA >500 IU/mL. Positive HCV RNA (confirmed by repeat testing);
- 4.HIV infection, known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
- 5.Prior gene therapy of any form;
- 6.History of severe allergic reactions to biologics (including antibiotics), antibodies, cytokines, or other macromolecular agents;
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- 7.Clinically significant CNS disorders: epilepsy, paresis, aphasia, stroke, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndrome;
- 8.Uncontrolled psychiatric illness;
- 9.Substance abuse/addiction;
- 10.Prohibited medications/treatments: Corticosteroids: ≥2 mg/kg prednisone (or equivalent >20 mg/day) within 2 weeks before leukapheresis.
- Chemo/radiotherapy: Anti-tumor radiotherapy or salvage chemotherapy within 3 weeks before leukapheresis.
- Immunosuppressants: Use within 4 weeks before leukapheresis. Other trials/major surgery: Participation in another clinical trial or major non-diagnostic surgery within 4 weeks before leukapheresis.
- Specific agents: Alemtuzumab within 6 months, or clofarabine/cladribine within 3 months before leukapheresis.
About this study
In this clinical study, participants with advanced renal cell carcinoma will receive a novel humanized CD70-targeted CAR-T-cell product that incorporates the TLR2 co-stimulatory domain. Peripheral blood mononuclear cells will be collected from each subject, genetically modified to express the CAR construct, and expanded ex vivo; after passing multiple quality-control assays, the CAR-T cells will be infused at the pre-specified dose. Post-infusion, the efficacy and safety of CD70-directed CAR-T-cell therapy will be systematically evaluated using clinical symptom assessments, quality-of-life questionnaires, biomarker analyses, laboratory tests, imaging studies, adverse-event monitoring, and long-term follow-up.
- Conditions
- Advanced Renal Cell Carcinoma
- Being tested
- CAR-T(CD70)
- Keywords
- CD70, CAR-T, Advanced renal cell carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T(CD70)Biological
In this clinical study, participants with advanced renal cell carcinoma will receive a novel humanized CD70-targeted CAR-T-cell product that incorporates the TLR2 co-stimulatory domain. Peripheral blood mononuclear cells will be collected from each subject, genetically modified to express the CAR construct, and expanded ex vivo; after passing multiple quality-control assays, the CAR-T cells will be administered intratumorally under CT guidance at the pre-specified dose. Following treatment, the efficacy and safety of CD70-directed CAR-T-cell therapy will be comprehensively assessed through clinical symptom evaluations, quality-of-life questionnaires, biomarker analyses, laboratory tests, imaging studies, adverse-event monitoring, and long-term follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Not described Receives: Biological: CAR-T(CD70) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune Effector Cell-Associated Neurotoxicity Syndrome（ICANS）
To assess the number and severity of ICANS after treatment according to the ASTCT criteria
Measured: in 6 months
Cytokine Release Syndrome（CRS）
To assess the number and severity of CRS after treatment according to the ASTCT criteria
Measured: in 6 months
Objective response rate (ORR)
Objective response rate (ORR) will be assessed by imaging at 1 month, 6 months, and 1 year post-CAR-T infusion.
Measured: 1 month, 6 months, and 1 year
Secondary outcomes (3)
Progression-Free Survival（PFS）
Measured: The time from the start of treatment to disease progression, up to a maximum of 36 months.
Overall Survival（OS）
Measured: The time from the start of treatment to death, up to a maximum of 36 months.
Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: in six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Renal Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Wei Guan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Guan, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113977
- Sponsor's protocol ID
- TJ-IRB202502144
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of a Novel Humanized CD70-Targeted CAR-T Cell Incorporating TLR2 for Advanced Renal Cell Carcinoma Therapy
- ClinicalTrials.gov ID
- NCT07113977
- Acronym / sponsor ID
- TJ-IRB202502144
- Conditions
- Advanced Renal Cell Carcinoma
- Keywords
- CD70, CAR-T, Advanced renal cell carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wei GuanUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Aug 2025 (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.
In this clinical study, participants with advanced renal cell carcinoma will receive a novel humanized CD70-targeted CAR-T-cell product that incorporates the TLR2 co-stimulatory domain. Peripheral blood mononuclear cells will be collected from each subject, genetically modified to express the CAR construct, and expanded ex vivo; after passing multiple quality-control assays, the CAR-T cells will be infused at the pre-specified dose. Post-infusion, the efficacy and safety of CD70-directed CAR-T-cell therapy will be systematically evaluated using clinical symptom assessments, quality-of-life questionnaires, biomarker analyses, laboratory tests, imaging studies, adverse-event monitoring, and long-term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Biological: CAR-T(CD70) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1. Voluntary participation with written informed consent provided by the patient or legally authorized representative;
- 2.Age 18-75 years (inclusive) at the time of consent, regardless of sex;
- 3.Advanced-stage renal cell carcinoma (RCC) with no curative treatment options, who have received ≥1 prior line of therapy and meet one or more of the following:
- 4.Histopathologically confirmed advanced RCC per WHO 2016 classification, with at least one measurable lesion evaluable by CT or MRI;
- 5.CD70 positivity in tumor tissue confirmed by immunohistochemistry (IHC);
Key exclusion criteria (13 listed)
- 1.Pregnant or lactating women;
- 2.Uncontrolled fungal, bacterial, Treponema pallidum, viral, or other infections;
- 3.Active hepatitis: HBV DNA >500 IU/mL. Positive HCV RNA (confirmed by repeat testing);
- 4.HIV infection, known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
- 5.Prior gene therapy of any form;
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 |
|---|---|---|
| CAR-T(CD70)In this clinical study, participants with advanced renal cell carcinoma will receive a novel humanized CD70-targeted CAR-T-cell product that incorporates the TLR2 co-stimulatory domain. Peripheral blood mononuclear cells will be collected from each subject, genetically modified to express the CAR construct, and expanded ex vivo; after passing multiple quality-control assays, the CAR-T cells will be administered intratumorally under CT guidance at the pre-specified dose. Following treatment, the efficacy and safety of CD70-directed CAR-T-cell therapy will be comprehensively assessed through clinical symptom evaluations, quality-of-life questionnaires, biomarker analyses, laboratory tests, imaging studies, adverse-event monitoring, and long-term follow-up. | Biological | Experimental Arm |
Primary outcome
Immune Effector Cell-Associated Neurotoxicity Syndrome（ICANS）
Time frame: in 6 months
To assess the number and severity of ICANS after treatment according to the ASTCT criteria
Cytokine Release Syndrome（CRS）
Time frame: in 6 months
To assess the number and severity of CRS after treatment according to the ASTCT criteria
Objective response rate (ORR)
Time frame: 1 month, 6 months, and 1 year
Objective response rate (ORR) will be assessed by imaging at 1 month, 6 months, and 1 year post-CAR-T infusion.
3 secondary outcomes
Progression-Free Survival（PFS）
Time frame: The time from the start of treatment to disease progression, up to a maximum of 36 months.
Overall Survival（OS）
Time frame: The time from the start of treatment to death, up to a maximum of 36 months.
Adverse Events
Time frame: in six months
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 11 Aug 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CAR-T(CD70) in people with Advanced Renal Cell Carcinoma, run by Wei Guan.
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 13 inclusion and 13 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: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune Effector Cell-Associated Neurotoxicity Syndrome（ICANS） (time frame: in 6 months). 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 11 Aug 2025.