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Clinical Study of CD70-targeted CAR-T Therapy for Advanced/Advanced Renal Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE1

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

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

NCT05420519•Chongqing Precision Biotech Co., Ltd

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years old, male or female;
•2. 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+));
•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;
•4. 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;
•5. ECOG 0-2 points (Appendix 2);
•6. The expected survival time is more than 12 weeks;
•7. No serious mental disorder;
•8. The functions of important organs are basically normal:
•1. Hematopoietic function: neutrophils 1.0×109/L, platelets 75×109/L, hemoglobin 80g/L;
•2. Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram;
+7 more criteria

Exclusion Criteria

•1. Those who have received CAR-T therapy or other gene-modified cell therapy before screening;
•2. Received anti-CD70 drug treatment before screening;
•3. 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;
•4. Received any of the following treatments before screening:
•1. 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;
•2. Received anti-tumor therapy such as chemotherapy and targeted therapy within 2 weeks or at least 5 half-lives (whichever is shorter) before apheresis;
•3. 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);
•4. Received live attenuated vaccine within 4 weeks before screening;
•5. Active infection or uncontrollable infection requiring systemic treatment within 1 week before screening;
•6. 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;
+11 more criteria

Locations (1)

The Second People's Hospital of Shandong Province

Jinan, Shandong, China

Key Dates

Start Date

December 31, 2021

Primary Completion Date

December 31, 2023

Completion Date

December 31, 2024

Last Updated

August 18, 2023

Enrollment

ESTIMATED participants

Conditions

Metastatic TumorRenal Cell CarcinomaAdvanced Cancer

Interventions

CD70 CAR-T cells

BIOLOGICAL

Contacts

Jingwang Bi, M.D

CONTACT

13066029387 jingwangbi@live.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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