Renal Cell Carcinoma (RCC)Phase 1NCT07181720
CD70-Targeted CAR-T Therapy in CD70-Positive Advanced Solid Tumors
A Phase 1 study testing CD70-targeted CAR-T cells in people with Renal Cell Carcinoma (RCC) and Lung Cancer, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.
Trial summary
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CD70-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CD70-positive advanced malignant tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma (RCC), Lung Cancer, Anaplastic Thyroid Carcinomas
- What is being tested?
- CD70-targeted CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2025to 31 May 2028
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, regardless of gender;
- Histologically or cytologically confirmed advanced/metastatic solid tumors (tumors with positive CD70 expression, confirmed histopathological ly with IHC 3+ score);
- Failed or intolerant to standard second-line treatments (at least one of the following: tyrosine kinase inhibitors (TKIs), poly(ADP-ribose) polymerase inhibitors (PARPi), anti-angiogenic therapy; disease progression or inability to tolerate surgery, chemotherapy, radiotherapy, or targeted therapy);
- At least one measurable lesion per RECIST 1.1 criteria, with measurable lesions defined as:
- Extranodal lesions with a long axis ≥10mm on CT scan;
- Lymph node lesions with a short axis ≥15mm on CT scan;
Show all 19Show fewer
- CT slice thickness ≤5mm.
- ECOG performance status of 0-2 ;
- Expected survival ≥12 weeks;
- No history of severe psychiatric disorders;
- Adequate organ function as defined by the following:
- Hematology: White blood cell count >2.0×10⁹/L, neutrophils >0.8×10⁹/L, lymphocytes >0.5×10⁹/L, platelets >50×10⁹/L, hemoglobin >90g/L;
- Cardiac: Echocardiogram showing left ventricular ejection fraction (LVEF) ≥50%, and ECG with no significant abnormalities;
- Renal: Serum creatinine ≤2.0×ULN;
- Hepatic: ALT and AST ≤3.0×ULN (may be relaxed to ≤5.0×ULN in cases with liver tumor infiltration); total bilirubin ≤2.0×ULN (may be relaxed to ≤3.0×ULN in cases with Gilbert's syndrome or liver tumor infiltration);
- Oxygen saturation ≥92% without supplemental oxygen;
- Ability to undergo single or venous blood collection, with no contraindications to cellular collection;
- Female subjects must agree to use reliable contraception (excluding fertility awareness methods) from the time of informed consent until 1 year after CAR-T cell infusion;
- Subject or authorized guardian agrees to participate in the trial and signs the informed consent form (ICF), indicating understanding of the trial's purpose and procedures and willingness to participate.
Who cannot join
- Prior treatment with anti-CD70 therapies;
- Active/symptomatic central nervous system (CNS) metastasis or meningeal metastasis: Subjects with treated brain metastases are eligible if treatment was completed ≥4 weeks prior to screening and there is no evidence of progression on imaging;
- Prior treatments within specified time frames:
- Participation in other interventional clinical trials within 3 months before cell infusion (for unapproved drugs, the last dose must be ≥3 months prior; for approved drugs, ≥5 half-lives prior to cell infusion);
- Received chemotherapy or targeted therapy within 2 weeks prior to blood collection or within 5 half-lives of the drug (whichever is shorter);
- Received >10mg/day prednisone (or equivalent) within 2 weeks prior to blood collection, unless for adrenal replacement or inhaled/local steroids (except for active autoimmune disease);
Show all 22Show fewer
- Received live attenuated vaccines within 4 weeks prior to screening;
- Active infection requiring systemic treatment or uncontrolled infection within 1 week before screening;
- History of any other malignancy within the past 3 years, except for treated and stable non-melanoma skin cancer or malignancies treated with curative intent and no evidence of active disease for ≥3 years;
- Cardiovascular conditions:
- NYHA Class III or IV heart failure;
- Myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to screening;
- Clinically significant ventricular arrhythmias or unexplained syncope (excluding vasovagal or dehydration);
- Severe non-ischemic cardiomyopathy;
- Active or uncontrolled autoimmune diseases such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, etc.;
- Positive for HBsAg or HBcAb with elevated HBV DNA in peripheral blood; positive for HCV antibodies with detectable HCV RNA levels; positive for HIV antibodies; positive syphilis test;
- Toxicity from prior anti-tumor treatments has not resolved to baseline or ≤grade 1, except for alopecia or peripheral neuropathy;
- History of venous thromboembolism (e.g., pulmonary embolism) requiring ongoing anticoagulation treatment, or meeting one of the following criteria:
- Severe bleeding (grade 3 or 4) lasting for ≥30 days;
- Post-thrombotic sequelae (e.g., persistent dyspnea and hypoxia) due to venous thromboembolism;
- Pregnant or breastfeeding women;
- Other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The 901 Hospital of Joint Logistics Support Force of People Liberation Army
Hefei, Anhui, 230031
About this study
Official title: Clinical Study of CD70-Targeted Chimeric Antigen Receptor T Lymphocytes (CAR-T) in Advanced CD70-Positive Malignant Solid Tumors
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CD70-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CD70-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CD70-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
Read the detailed description
According to the different infusion methods, patients will be assigned to three parallel subgroups: intravenous infusion, intrapleural infusion, and intraperitoneal infusion.
Within each subgroup, the study is conducted in two sequential parts:
- .Part A (dose-escalation): escalation begins at the lowest dose level; 3-6 subjects are enrolled at each dose level;
- .Part B (dose-expansion): additional subjects are treated at the recommended dose identified in Part A to further evaluate safety and preliminary efficacy.
- Conditions
- Renal Cell Carcinoma (RCC), Lung Cancer, Anaplastic Thyroid Carcinomas, Ovarian Cancer, Cervical Cancer, Thymic Carcinoma
- Being tested
- CD70-targeted CAR-T cells
- Medical subject headings
- Carcinoma, Renal Cell, Lung Neoplasms, Thyroid Carcinoma, Anaplastic, Ovarian Neoplasms, Uterine Cervical Neoplasms, Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD70-targeted CAR-T cellsBiological
Administration method: intravenous infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.
CD70-targeted CAR-T cellsBiological
Administration method: intrapleural infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.
CD70-targeted CAR-T cellsBiological
Administration method: intraperitoneal infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous of CD70-targeted CAR-T | Experimental | Infusion of CD70-targeted CAR-T cells by dose of 3-10x10^5 cells/kg Receives: Biological: CD70-targeted CAR-T cells |
| Intrapleural infusion of CD70-targeted CAR-T | Experimental | Infusion of CD70-targeted CAR-T cells by dose of 3-10x10^5 cells/kg Receives: Biological: CD70-targeted CAR-T cells |
| Intraperitoneal infusion of CD70-targeted CAR-T | Experimental | Infusion of CD70-targeted CAR-T cells by dose of 3-10x10^5 cells/kg Receives: Biological: CD70-targeted CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of CAR-T cell preparations in the treatment of CD70-positive advanced malignancies [Safety and Tolerability]
Incidence of adverse events during the study, evaluated per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) criteria
Measured: 1 month
Obtained the recommended dose and infusion regimen of CAR-T cells for the treatment of patients with CD70-positive advanced malignancies [Safety and Tolerability]
Dose-limiting toxicity after CD70 CAR-T cell infusion
Measured: 1 month
Secondary outcomes (4)
Assessing disease control rates of CAR-T cell preparations in CD70-positive advanced malignancies [Effectiveness]
Disease control rate: The proportion of subjects who achieved CR, PR, SD after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.
Measured: 1 and 3 months
To characterize the in-vivo cellular kinetics of CAR-T cells【pharmacokinetics】
Cmax: maximum observed level of circulating CAR-T cells in peripheral blood after infusion
Measured: From infusion through Month 3
To characterize the in-vivo cellular kinetics of CAR-T cells【pharmacokinetics】
To determine the time to maximum observed level of circulating CAR-T cells (Tmax)；To estimate AUC0-28d and AUC0-90d for circulating CAR-T cells
Measured: From infusion through Month 3
To assess the inflammatory response following CAR-T cell infusion
Serum levels of inflammation-related markers and cytokines, including but not limited to C-reactive protein (CRP), interleukin-6 (IL-6), and ferritin
Measured: From infusion through Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start12 Sep 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 May 2028 (estimated)
Why it stopped: Sponsor stopped the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (RCC)Studies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Precision Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donglai Lv, MD, Principal investigator, The 901 Hospital of Joint Logistics Support Force of People Liberation Army
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181720
- Sponsor's protocol ID
- PBC095
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2025
- Last updated
- 11 Sep 2026
- 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 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of CD70-Targeted Chimeric Antigen Receptor T Lymphocytes (CAR-T) in Advanced CD70-Positive Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07181720
- Acronym / sponsor ID
- PBC095
- Conditions
- Renal Cell Carcinoma (RCC), Lung Cancer, Anaplastic Thyroid Carcinomas, Ovarian Cancer, Cervical Cancer, Thymic Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Sponsor stopped the study.
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chongqing Precision Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 18 Sep 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.
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CD70-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CD70-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CD70-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
Detailed description
According to the different infusion methods, patients will be assigned to three parallel subgroups: intravenous infusion, intrapleural infusion, and intraperitoneal infusion.
Within each subgroup, the study is conducted in two sequential parts:
- .Part A (dose-escalation): escalation begins at the lowest dose level; 3-6 subjects are enrolled at each dose level;
- .Part B (dose-expansion): additional subjects are treated at the recommended dose identified in Part A to further evaluate safety and preliminary efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intravenous of CD70-targeted CAR-T | Experimental | Biological: CD70-targeted CAR-T cellsInfusion of CD70-targeted CAR-T cells by dose of 3-10x10^5 cells/kg |
| Intrapleural infusion of CD70-targeted CAR-T | Experimental | Biological: CD70-targeted CAR-T cellsInfusion of CD70-targeted CAR-T cells by dose of 3-10x10^5 cells/kg |
| Intraperitoneal infusion of CD70-targeted CAR-T | Experimental | Biological: CD70-targeted CAR-T cellsInfusion of CD70-targeted CAR-T cells by dose of 3-10x10^5 cells/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥18 years, regardless of gender;
- Histologically or cytologically confirmed advanced/metastatic solid tumors (tumors with positive CD70 expression, confirmed histopathological ly with IHC 3+ score);
- Failed or intolerant to standard second-line treatments (at least one of the following: tyrosine kinase inhibitors (TKIs), poly(ADP-ribose) polymerase inhibitors (PARPi), anti-angiogenic therapy; disease progression or inability to tolerate surgery, chemotherapy, radiotherapy, or targeted therapy);
- At least one measurable lesion per RECIST 1.1 criteria, with measurable lesions defined as:
- ECOG performance status of 0-2 ;
Key exclusion criteria (22 listed)
- Prior treatment with anti-CD70 therapies;
- Active/symptomatic central nervous system (CNS) metastasis or meningeal metastasis: Subjects with treated brain metastases are eligible if treatment was completed ≥4 weeks prior to screening and there is no evidence of progression on imaging;
- Prior treatments within specified time frames:
- Active infection requiring systemic treatment or uncontrolled infection within 1 week before screening;
- History of any other malignancy within the past 3 years, except for treated and stable non-melanoma skin cancer or malignancies treated with curative intent and no evidence of active disease for ≥3 years;
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 |
|---|---|---|
| CD70-targeted CAR-T cellsAdministration method: intravenous infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion. | Biological | Intravenous of CD70-targeted CAR-T |
| CD70-targeted CAR-T cellsAdministration method: intrapleural infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion. | Biological | Intrapleural infusion of CD70-targeted CAR-T |
| CD70-targeted CAR-T cellsAdministration method: intraperitoneal infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion. | Biological | Intraperitoneal infusion of CD70-targeted CAR-T |
Primary outcome
To evaluate the safety of CAR-T cell preparations in the treatment of CD70-positive advanced malignancies [Safety and Tolerability]
Time frame: 1 month
Incidence of adverse events during the study, evaluated per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) criteria
Obtained the recommended dose and infusion regimen of CAR-T cells for the treatment of patients with CD70-positive advanced malignancies [Safety and Tolerability]
Time frame: 1 month
Dose-limiting toxicity after CD70 CAR-T cell infusion
4 secondary outcomes
Assessing disease control rates of CAR-T cell preparations in CD70-positive advanced malignancies [Effectiveness]
Time frame: 1 and 3 months
To characterize the in-vivo cellular kinetics of CAR-T cells【pharmacokinetics】
Time frame: From infusion through Month 3
To characterize the in-vivo cellular kinetics of CAR-T cells【pharmacokinetics】
Time frame: From infusion through Month 3
To assess the inflammatory response following CAR-T cell infusion
Time frame: From infusion through Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Renal Cell Carcinoma (RCC)
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingObservational study
Federated Learning in Renal Tumor Model
Renal Tumors
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Active, not recruiting
App-Based Mindfulness Intervention for the Improvement of Quality of Life in Patients With Metastatic Renal Cell Cancer
Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8
RecruitingPhase 3
A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)
Carcinoma, Renal Cell
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. This study is not recruiting at the moment.
Donglai Lv, MD principal investigator
The 901 Hospital of Joint Logistics Support Force of People Liberation Army
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD70-targeted CAR-T cells in people with Renal Cell Carcinoma (RCC) and Lung Cancer, run by Chongqing Precision Biotech Co., Ltd at 1 site 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 19 inclusion and 22 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: paused, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
To evaluate the safety of CAR-T cell preparations in the treatment of CD70-positive advanced malignancies [Safety and Tolerability] (time frame: 1 month). The study lists 2 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 Sep 2026.