AzTrials
AzTrials

Metastatic TumorPhase 1NCT05420519

Clinical Study of CD70-targeted CAR-T Therapy for Advanced/Advanced Renal Cancer

A Phase 1 study testing CD70 CAR-T cells in people with Metastatic Tumor and Renal Cell Carcinoma, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with advanced/metastatic renal cell carcinoma, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CD70 CAR-T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
31 Dec 2021to 31 Dec 2024
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 old, male or female;
  • Diagnosed with advanced/metastatic renal cell carcinoma (staging according to 2017AJCC) by histopathology or cytology (paraffin section or fresh biopsy tumor tissue specimens), and the tumor is positive for CD70 expression (positive for tumor CD70 confirmed by histology or pathology) (IHC 3+));
  • At least after TKI, anti-vascular drug treatment is ineffective, there is no available standard treatment plan or standard treatment fails or cannot tolerate (disease progression or intolerance such as surgery, chemotherapy, radiotherapy, targeted therapy, etc.) no effective treatment;
  • Measurable and evaluable lesions specified by RECIST version 1.1: Measurable disease is defined as at least one lesion that can be accurately measured on at least one level (long diameter needs to be recorded); ), each lesion must be >10mm when measured by Magnetic Resonance Imaging (MRI), The lymph node must be >15mm in the short axis;
  • ECOG 0-2 points (Appendix 2);
  • The expected survival time is more than 12 weeks;
Show all 17Show fewer
  • No serious mental disorder;
  • The functions of important organs are basically normal:
  • Hematopoietic function: neutrophils 1.0×109/L, platelets 75×109/L, hemoglobin 80g/L;
  • Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram;
  • Renal function: serum creatinine≤2.0×ULN;
  • Liver function: ALT and AST ≤2.0×ULN (for patients with liver tumor infiltration, it can be relaxed to ≤3.0×ULN);
  • Total bilirubin ≤2.0×ULN (Gilbert syndrome or combined liver tumor infiltration can be relaxed to ≤3.0×ULN);
  • Oxygen saturation > 92% in non-oxygen state.
  • Have apheresis or venous blood collection standards, and have no other contraindications for cell collection;
  • Subjects agree to use reliable and effective contraceptive methods for contraception within 1 year after signing the informed consent form to receiving CAR-T cell infusion (excluding rhythm contraception);
  • Subjects or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.

Who cannot join

  • Those who have received CAR-T therapy or other gene-modified cell therapy before screening;
  • Received anti-CD70 drug treatment before screening;
  • Active/symptomatic central nervous system metastases or meningeal metastases at the time of screening; subjects with brain metastases who have been treated must be confirmed to have no imaging evidence of progression ≥ 4 weeks after the end of treatment before they can be enrolled;
  • Received any of the following treatments before screening:
  • Participated in other interventional clinical studies before screening, including: the last use of unmarketed new drugs is less than 3 months from the time of cell reinfusion, or the last use of marketed drugs is less than 5 months from the time of cell reinfusion half-life;
  • Received anti-tumor therapy such as chemotherapy and targeted therapy within 2 weeks or at least 5 half-lives (whichever is shorter) before apheresis;
Show all 21Show fewer
  • Received systemic corticosteroid therapy at doses greater than 10 mg/day prednisone (or equivalent doses of other corticosteroids) within 2 weeks prior to apheresis (inhalation or topical is allowed in the absence of active autoimmune disease Use steroids and adrenal corticosteroid replacement at doses greater than 10 mg/day of prednisone);
  • Received live attenuated vaccine within 4 weeks before screening;
  • Active infection or uncontrollable infection requiring systemic treatment within 1 week before screening;
  • Patients with other malignancies other than renal cancer within 3 years before screening, except for the following cases: malignant tumors that have received radical treatment, and no known active disease within ≥3 years before enrollment; or Treated non-melanoma skin cancer with no evidence of disease;
  • Suffering from any of the following heart diseases:
  • New York Heart Association (NYHA) stage III or IV congestive heart failure;
  • Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment;
  • Clinically significant ventricular arrhythmia, or a history of unexplained syncope (except those caused by vasovagal or dehydration);
  • History of severe nonischemic cardiomyopathy.
  • Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, etc.;
  • Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is greater than the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood type C Hepatitis virus (HCV) RNA titer detection greater than normal range Human immunodeficiency virus (HIV) antibody positive; syphilis positive test; cytomegalovirus (CMV) DNA test positive;
  • The subject has experienced venous thromboembolic events (for example: pulmonary embolism) and still needs anticoagulation therapy, or meets the following conditions: a. Bleeding with grades 3 to 4 for more than 30 days; b. There are veins Sequelae caused by embolism (such as persistent dyspnea and hypoxia); (Note: subjects who have venous embolism but do not meet the above conditions can participate in the trial);
  • Poorly controlled hypertension, defined as systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg (The measurement of blood pressure is based on the average of 3 readings at least 2 minutes apart. Patients with blood pressure ≥150/90mmHg at the initial screening can receive antihypertensive treatment, and if they are well controlled after treatment, and blood pressure <150/90mmHg can be performed. filter);
  • Women who are pregnant or breastfeeding, and male or female subjects who plan to have children within 1 year after receiving CAR-T cell reinfusion;
  • Other investigators deem it unsuitable to participate in the study.

Trial locations and contacts

1 site in 1 country.

Jingwang Bi, M.D contact

13066029387

jingwangbi@live.cn

China1 site, 1 recruiting

  • The Second People's Hospital of Shandong Province

    Jinan, Shandong, 250000

    Jingwang Bi, MD, 13066029387, jingwangbi@live.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Study of CD70-targeted CAR-T Therapy for Advanced/Advanced Renal Cancer

This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with advanced/metastatic renal cell carcinoma, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.

Read the detailed description

This is a single-center, single-arm, open-label study. Intravenous infusion group have 4 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 12 subjects with CD70-positive advanced/metastatic renal cell carcinoma in Dose discovery phase and 12 subjects in dose expansion phase.

Being tested
CD70 CAR-T cells
Keywords
CAR-T, CD70
Medical subject headings
Neoplasm Metastasis, Carcinoma, Renal Cell

What participants receive

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

  • CD70 CAR-T cellsBiological

    Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.

Study groups in NCT05420519
Study groupRoleWhat they receive
CD70-targeted CAR-TExperimentalInfusion of CD70-targeted CAR-T cells by dose of 1-10x106 cells/kg
Receives: Biological: CD70 CAR-T cells

What is being measured

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

  1. Incidence of Adverse events after CD70 CAR-T cells infusion [Safety and Tolerability]

    Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

    Measured: 28 days

  2. Obtain the maximum tolerated dose of CD70 CAR-T cells[Safety and Tolerability]

    Dose-limiting toxicity after cell infusion

    Measured: 28 days

Secondary outcomes (9)

  1. Disease control rate of CAR-T cell preparations in CD70 positive advanced malignancies [Effectiveness]

    Disease control rate: including CR, PR and SD(Assessed based on RECIST criteria)

    Measured: 3 months

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

    Objective response rate includes：CR、PR(Assessed based on RECIST criteria)

    Measured: 3 months

  3. 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

    Measured: 3 months

  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 based on RECIST criteria)

    Measured: 2 years

  5. 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)

    Measured: 2 years

  6. AUCS of CD70 CAR-T cells [Cell dynamics]

    AUCS is defined as the area under the curve in 90 days

    Measured: 3 months

  7. CMAX of CD70 CAR-T cells [Cell dynamics]

    CMAX is defined as the highest concentration of CD70 CAR-T cells expanded in peripheral blood

    Measured: 3 months

  8. TMAX of CD70 CAR-T cells[Cell dynamics]

    TMAX is defined as the time to reach the highest concentration

    Measured: 3 months

  9. Pharmacodynamics of CD70 CAR-T cells[Cell dynamics]

    Concentration levels of CAR-T-related serum cytokines such as CRP, IL-6, ferritin at each time point

    Measured: 3 months

Timeline

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

  1. First posted15 Jun 2022
  2. Study start31 Dec 2021
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2024 (estimated)

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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05420519
Sponsor's protocol ID
PBC036
Status last verified
Aug 2023
First submitted
12 Jun 2022
Last updated
18 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CD70 CAR-T cells in people with Metastatic Tumor and Renal Cell Carcinoma, 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 17 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 18 Aug 2023. 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?

Contact Jingwang Bi, M.D (13066029387, jingwangbi@live.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse events after CD70 CAR-T cells infusion [Safety and Tolerability] (time frame: 28 days). 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?

On the ClinicalTrials.gov record for NCT05420519.

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 18 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in