ClinicalTrials.gg
SuspendedNCT07181720Updated Sep 11, 2026

CD70-Targeted CAR-T Therapy in CD70-Positive Advanced Solid Tumors

A Phase 1 interventional study of CD70-targeted CAR-T cells and CD70-targeted CAR-T cells in Renal Cell Carcinoma (RCC), Lung Cancer and Anaplastic Thyroid Carcinomas, sponsored by Chongqing Precision Biotech Co., Ltd. Suspended at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Chongqing Precision Biotech Co., Ltd · Phase 1, Interventional, and Treatment

Why this study was suspended
Sponsor stopped the study.
Phase
Phase 1
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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:

  1. .Part A (dose-escalation): escalation begins at the lowest dose level; 3-6 subjects are enrolled at each dose level;
  2. .Part B (dose-expansion): additional subjects are treated at the recommended dose identified in Part A to further evaluate safety and preliminary efficacy.
02

Conditions studied

  • Renal Cell Carcinoma (RCC)
  • Lung Cancer
  • Anaplastic Thyroid Carcinomas
  • Ovarian Cancer
  • Cervical Cancer
  • Thymic Carcinoma
03

In context

Carcinoma, Renal Cell

2,037 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.

This study's planned enrollment of 90 is above the median of 43 across 1,564 interventional studies indexed under Carcinoma, Renal Cell.

Browse Carcinoma, Renal Cell studies →

Lead sponsor

Chongqing Precision Biotech Co., Ltd is the lead sponsor of 51 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥18 years, regardless of gender;
  2. or cytologically confirmed advanced/ solid tumors (tumors with positive CD70 expression, confirmed histopathological ly with IHC 3+ score);
  3. Failed or intolerant to standard 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);
  4. At least one per 1.1 criteria, with measurable lesions defined as:

    1. Extranodal lesions with a long axis ≥10mm on CT scan;
    2. Lymph node lesions with a short axis ≥15mm on CT scan;
    3. CT slice thickness ≤5mm.
  5. performance status of 0-2 ;
  6. Expected survival ≥12 weeks;
  7. No history of severe psychiatric disorders;
  8. Adequate organ function as defined by the following:

    1. Hematology: White blood cell count >2.0×10⁹/L, neutrophils >0.8×10⁹/L, lymphocytes >0.5×10⁹/L, >50×10⁹/L, >90g/L;
    2. Cardiac: Echocardiogram showing (LVEF) ≥50%, and with no significant abnormalities;
    3. Renal: Serum creatinine ≤2.0×;
    4. Hepatic: and AST ≤3.0×ULN (may be relaxed to ≤5.0×ULN in cases with liver tumor infiltration); total ≤2.0×ULN (may be relaxed to ≤3.0×ULN in cases with Gilbert's syndrome or liver tumor infiltration);
    5. Oxygen saturation ≥92% without supplemental oxygen;
  9. Ability to undergo single or venous blood collection, with no to cellular collection;
  10. Female subjects must agree to use reliable (excluding fertility awareness methods) from the time of until 1 year after CAR-T cell infusion;
  11. 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.

Exclusion criteria

Exclusion Criteria:

  1. Prior treatment with anti-CD70 therapies;
  2. Active/symptomatic central nervous system (CNS) or meningeal metastasis: Subjects with treated are eligible if treatment was completed ≥4 weeks prior to screening and there is no evidence of progression on imaging;
  3. Prior treatments within specified time frames:

    1. 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);
    2. Received chemotherapy or targeted therapy within 2 weeks prior to blood collection or within 5 half-lives of the drug (whichever is shorter);
    3. Received >10mg/day prednisone (or equivalent) within 2 weeks prior to blood collection, unless for adrenal replacement or inhaled/local (except for active disease);
    4. Received within 4 weeks prior to screening;
  4. Active infection requiring systemic treatment or uncontrolled infection within 1 week before screening;
  5. History of any other 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;
  6. Cardiovascular conditions:

    1. Class III or IV heart failure;
    2. Myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to screening;
    3. ventricular arrhythmias or unexplained syncope (excluding vasovagal or dehydration);
    4. Severe non-ischemic cardiomyopathy;
  7. Active or uncontrolled autoimmune diseases such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, etc.;
  8. Positive for or HBcAb with elevated HBV DNA in peripheral blood; positive for antibodies with detectable HCV RNA levels; positive for antibodies; positive syphilis test;
  9. Toxicity from prior anti-tumor treatments has not resolved to baseline or ≤grade 1, except for alopecia or peripheral neuropathy;
  10. History of venous thromboembolism (e.g., pulmonary embolism) requiring ongoing anticoagulation treatment, or meeting one of the following criteria:

    1. Severe bleeding (grade 3 or 4) lasting for ≥30 days;
    2. Post-thrombotic sequelae (e.g., persistent dyspnea and hypoxia) due to venous thromboembolism;
  11. Pregnant or breastfeeding women;
  12. Other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in the trial.
Terms in these criteria, in plain language(26)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Intravenous of CD70-targeted CAR-T

    Infusion of CD70-targeted CAR-T cells by dose of 3-10x10\^5 cells/kg

    Biological: CD70-targeted CAR-T cells

  • Experimental
    Intrapleural infusion of CD70-targeted CAR-T

    Infusion of CD70-targeted CAR-T cells by dose of 3-10x10\^5 cells/kg

    Biological: CD70-targeted CAR-T cells

  • Experimental
    Intraperitoneal infusion of CD70-targeted CAR-T

    Infusion of CD70-targeted CAR-T cells by dose of 3-10x10\^5 cells/kg

    Biological: CD70-targeted CAR-T cells

Interventions

  • BiologicalCD70-targeted CAR-T cells

    Administration method: intravenous infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.

  • BiologicalCD70-targeted CAR-T cells

    Administration method: intrapleural infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.

  • BiologicalCD70-targeted CAR-T cells

    Administration method: intraperitoneal infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 month

  2. 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

    Time frame: 1 month

Secondary outcomes

  1. 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.

    Time frame: 1 and 3 months

  2. 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

    Time frame: From infusion through Month 3

  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

    Time frame: From infusion through Month 3

  4. 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

    Time frame: From infusion through Month 3

Other outcomes

  1. Objective response rate (ORR) of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies [Effectiveness]

    Objective response rate includes:The proportion of subjects who achieved CR, PR 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.

    Time frame: 2 years

  2. Duration of Response (DOR) of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies [Effectiveness]

    DOR will be assessed from the first assessment of CR/PR/SD to the first assessment of recurrence or progression of the disease or death from any cause

    Time frame: 2 years

  3. Progress-free survival(PFS) of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies [Effectiveness]

    PFS will be assessed from the first CD70 CAR-T cell infusion to death from any cause or the first assessment of progression(Assessed based on RECIST criteria)

    Time frame: 2 years

  4. Overall survival(OS)of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies [Effectiveness]

    OS will be assessed from the first CD70 CAR-T cell infusion to death from any cause (Assessed by investigators based on IRECIST criteria)

    Time frame: 2 years

07

Study locations

1 site
  • The 901 Hospital of Joint Logistics Support Force of People Liberation Army
    Hefei, Anhui 230031, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2025 (actual). Primary completion is estimated for Mar 2028, 30 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2025
First posted
Sep 18, 2025
StartActual
Sep 12, 2025
Primary completionEst.
Mar 31, 2028
CompletionEst.
May 31, 2028
Last update
Sep 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07181720
Responsible party
Sponsor
First posted
Sep 18, 2025
Start date
Sep 12, 2025
Primary completion
Mar 31, 2028 (estimated)
Completion
May 31, 2028 (estimated)
Last update
Sep 11, 2026

Study contacts

Donglai Lv, MD
principal investigator · The 901 Hospital of Joint Logistics Support Force of People Liberation Army

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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