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Renal Cell CarcinomaEarly Phase 1NCT06586658

Anti-CD70-CAR-T Cell Injection for the Treatment of Locally Advanced or Relapsed/Metastatic CD70+ Inoperable Renal Cells

A Early Phase 1 study testing anti-CD70-CAR-T cells in people with Renal Cell Carcinoma, run by Shanghai Changzheng Hospital at 1 site in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This is an investigator-initiated trial to evaluate the role of anti-CD70-CAR T cells in locally advanced or recurrent/metastatic renal cell carcinoma that is inoperable. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
anti-CD70-CAR-T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
6 Sep 2024to 16 Jul 2027
Phase
Early 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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Understand and sign informed consent, and voluntarily participate in clinical research;
  • Age ≥18, and <70 years old, gender is not limited;
  • Histopathologically or cytologically confirmed advanced malignant renal cell carcinoma of CD70+ with at least VEGFR-targeted therapy and an immune checkpoint therapy (either combination therapy or sequential therapy);
  • At least one measurable lesion with a maximum diameter of less than 6 cm according to RECIST 1.1;
  • Expected survival ≥12 weeks;
  • ECOG score ≤2 points;
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  • Have sufficient hematologic function and have not received blood transfusion or cell growth factor therapy within 7 days prior to the hematologic evaluation during the screening period (2 weeks interval is required for those receiving long-acting agents such as PEG-rhG-CSF, allowing the use of recombinant erythropoietin) :
  • Neutrophil absolute value ≥1.5×109/L
  • Hemoglobin ≥80g/L
  • Platelets ≥75×109/L
  • Lymphocytes (ALC) ≥0.3×109/L
  • Adequate liver function: serum total bilirubin ≤1.5× upper limit of normal (ULN) (for Gilbert syndrome patients, total bilirubin ≤3×ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN; If there is liver metastasis, allow AST, ALT≤5×ULN);
  • Adequate renal function: creatinine ≤1.5×ULN or endogenous creatinine clearance ≥50 mL/min (using Cockcroft Gault formula);
  • Left ventricular ejection fraction (LVEF) of echocardiography was ≥50%.
  • There was no evidence of dyspnea at rest and pulse oximetry was >93% without oxygen.
  • Activated partial thromboplastin time (APTT) ≤1.5×ULN and International normalized ratio (INR) ≤1.5×ULN;
  • Good venous access (for apheresis) and no other contraindications for blood cell separation;
  • Pregnancy tests for women of childbearing age must be negative. All subjects must agree to use an effective contraceptive method at the same time from the time of signing the informed consent to 12 months after the final administration of the study drug.

Who cannot join

  • Patients are not eligible to participate in this trial if they meet any of the following conditions:
  • Previous use of any CAR T cell products or other genetically modified T cell therapy;
  • Patients who have a history of allogeneic stem cells or solid organ transplantation or are waiting for organ transplantation;
  • Patients with acute or uncontrolled active infection who currently require intravenous anti-infective therapy, and patients taking antibiotics to prevent infection should be allowed to participate in the study at the discretion of the investigator;
  • Active hepatitis B (hepatitis B surface antigen positive and hepatitis B DNA>103 copies /mL or >200IU/mL), active hepatitis C (hepatitis C antibody positive and RNA positive); Active syphilis infection (RPR or TRUst-positive), human immunodeficiency virus (HIV) infection (HIV positive);
  • Patients with low sodium and/or hypokalemia with blood sodium <125mmol/L and/or blood potassium <3.5mmol/L (unless sodium and/or potassium supplementation is required prior to study participation to restore blood sodium and/or potassium above this level);
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  • Imaging results showed that the proportion of liver replaced by tumor was ≥50%;
  • There was clinically uncontrollable third space effusion, which was judged by the researcher not suitable for inclusion;
  • Previously received anti-CD70 therapy;
  • Receiving continuous systemic steroid medication (prednisone > 10mg/ day or equivalent dose of other hormones) within 14 days of preapheresis or 3 days before cell therapy, except for recent or current topical steroid use;
  • Toxicity from previous antitumor therapy has not recovered (>CTCAE version 5.0 Grade 1), except for alopecia, pigmentation, and other tolerable events as determined by the investigator or laboratory abnormalities permitted under the protocol;
  • The eluting period of preaphermative antitumor therapy met the following requirements:
  • ≦2 weeks or 5 half-lives of chemotherapy, small molecule targeted therapy, radiotherapy, endocrine therapy, immunomodulatory therapy, and Chinese medicine with anti-tumor indications
  • ≦4 weeks of macromolecular targeted therapy and immunotherapy
  • ≦4 weeks of anti-tumor vaccine
  • ≦4 weeks of investigational medication/therapy
  • Previous or current co-occurrence of other malignancies (other than basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix and other malignancies that have been cured or are free of disease and have not been treated in the past five years);
  • Previous history of primary or secondary tumors of the central nervous system (CNS) (except stable ≥4 weeks after treatment, no current CNS related signs and no drug control ≥14 days);
  • Patients with other central nervous system diseases (such as seizures, cerebral hemorrhage, dementia, etc.) that researchers have judged may affect the safety of subjects;
  • Uncontrolled hypertension (systolic blood pressure ≥150 MMHG and/or diastolic blood pressure ≥95mmHg after standard treatment), unstable angina, congestive heart failure of New York Heart Association grade III or higher, or significant abnormalities on ECG, Severe arrhythmias requiring treatment and a history of myocardial infarction within 6 months prior to initiation of study therapy;
  • Patients with severe respiratory diseases, such as interstitial lung disease, active pulmonary tuberculosis, and patients who have received extensive radiation therapy in the lung, were not considered suitable for inclusion by researchers;
  • Patients with active or past autoimmune diseases with the possibility of recurrence (e.g. systemic lupus erythematosus, rheumatoid arthritis, etc.), except for type 1 diabetes, hypothyroidism requiring hormone replacement therapy, skin diseases without systemic treatment (e.g. vitiligo, psoriasis or alopecia);
  • In the investigator's judgment, any serious or uncontrollable systemic disease, systemic comorbiditis, other serious comorbiditis (such as hemophagic cell syndrome, etc.), or special conditions of the tumor may make the patient unfit to enter the study or affect protocol compliance, or significantly interfere with the correct evaluation of the safety, toxicity, and effectiveness of the investigatory drugs;
  • Had any major surgery (other than exploratory laparotomy or laparoscopic exploration) or severe trauma within 4 weeks prior to apheresis, had major surgery scheduled during DLT observation, or had not fully recovered from any previous invasive procedure;
  • Patients who are allergic to or intolerant to antisepsis agents that may be used during the study or to medications that are appropriate for the treatment of CRS, including but not limited to fludarabine and cyclophosphamide or toluzumab; Known to be allergic to anti-CD70-CAR-T ingredients; Or have any history of severe allergies, such as anaphylactic shock;
  • Women who are pregnant, who plan to become pregnant during the trial, or who are breastfeeding;
  • Patients judged by the investigator to be unable or unwilling to comply with clinical protocols;
  • Persons involved in the planning and execution of the research.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Changzheng hospital

    Shanghai, Shanghai Municipality, 201109

Other trials in China

About this study

Official title: An Exploratory Clinical Study of the Safety and Efficacy of Anti-CD70-CAR-T Cell Injection in Patients With Locally Advanced or Relapsed/Metastatic Renal Cell Carcinoma With CD70+ Inoperable

This is an investigator-initiated trial to evaluate the role of anti-CD70-CAR T cells in locally advanced or recurrent/metastatic renal cell carcinoma that is inoperable.

Read the detailed description

This is an investigator-initiated trial to evaluate the role of anti-CD70-CAR T cells in locally advanced or recurrent/metastatic renal cell carcinoma that is inoperable

Study intervention consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.

Interim analysis will be performed when the last participant finishes the visit of 12 weeks after CAR-T cells infusion.

Being tested
anti-CD70-CAR-T cells
Keywords
CART, CD70, Renal carcinoma
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anti-CD70-CAR-T cellsBiological

    The subjects received infusions of anti-CD70 CART cells following completion of lymphodepleting preconditioning chemotherapy. Dosage: 3×10^6 cells/Kg; 1×10^7 cells/Kg; 2×10^7 cells/Kg.

Study groups in NCT06586658
Study groupRoleWhat they receive
Assigned InterventionsExperimentalNot described
Receives: Biological: anti-CD70-CAR-T cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT) within 28 days after infusion

    Measured: Within 28 days after infusion

  2. Incidence and severity of adverse events after infusion (including abnormal test values, physical examination, vital sign parameters)

    Measured: 1 year

  3. Maximum tolerated dose (MTD) or recommended dose in subsequent clinical trials

    Measured: Up to 28 days from CAR-T infusion

Secondary outcomes (3)

  1. Progression-free survival (PFS)

    Progression-free survival (PFS) is the time between the date of first administration and the date of tumor progression (PD as assessed by imaging diagnosis) or the date of all-cause death (whichever occurs first).

    Measured: From date of CAR-T infusion until date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 years

  2. Overall survival (OS)

    Overall survival (OS) is the time between the date of first dosing and the date of all-cause death.

    Measured: From date of CAR-T infusion until date of death from any cause, assessed up to 15 years

  3. Duration of efficacy (DOR)

    Duration of efficacy (DOR) is the time between meeting the criteria for treatment effectiveness (first recorded complete or partial response) and the first clear recurrence or progression.

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start6 Sep 2024
  3. Primary completion16 Jul 2027 (estimated)
  4. Study completion16 Jul 2027 (estimated)

Why it stopped: Modifications to the trial design

Resources

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
Model description
Single Group Assignment
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06586658
Sponsor's protocol ID
CD70-CN-A5
Status last verified
Jul 2026
First submitted
7 Aug 2024
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to concerns regarding the security of patient personal information.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing anti-CD70-CAR-T cells in people with Renal Cell Carcinoma, run by Shanghai Changzheng Hospital 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 18 inclusion and 28 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 23 Jul 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?

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?

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?

Dose-limiting toxicity (DLT) within 28 days after infusion (time frame: Within 28 days after 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?

On the ClinicalTrials.gov record for NCT06586658.

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 23 Jul 2026.

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