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A Clinical Research About CD70-positive Advanced/Metastatic Solid Tumors Treated by CD70-targeted CAR-T | Clinical Trials | Clareo Health

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A Clinical Research About CD70-positive Advanced/Metastatic Solid Tumors Treated by CD70-targeted CAR-T

A Phase I Clinical Study to Assess the Safety and Tolerability of CD70-targeting CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors

NCT05468190•Chongqing Precision Biotech Co., Ltd

View on ClinicalTrials.gov

Summary

As a phase I clinical research，this study plans to evaluate the safety and tolerability of CD70-targeting CAR-T cells in the treatment of CD70-positive advanced/metastatic solid tumors, and obtain recommended doses and infusion patterns.

Detailed Description

This is a single-center, double-arm, open-label study. The research designs to follow 2 groups：Intravenous infusion group and Intraperitoneal injection group；each group sets up 2 phases,the first phase is dose discovery phase to obtain recommended doses,the second phase is dose expansion phase to verify the safety in the recommended doses. In the discovery phase,each group puts up 4 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 12 subjects with CD70-positive advanced/metastatic solid tumors.In the dose expansion phase,each group will choose one or two dose groups to verify the safety and efficacy at this dose,and plan to recruit about 6 subjects in each dose group.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years old, male or female;
•2. Advanced/metastatic solid tumor confirmed by histopathology or cytology (paraffin section or fresh biopsy tumor tissue specimen) (positive tumor CD70 expression (tumor CD70 positive (IHC 3+) confirmed by histology or pathology)) ;
•3. At least after TKI/PARPi, anti-vascular drug treatment is ineffective, there is no available standard treatment plan or standard treatment fails or intolerable (disease progression or intolerance such as surgery, chemotherapy, radiotherapy, targeted therapy, etc.), There is currently no effective treatment;
•4. Measurable and evaluable lesions defined 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); ), when measured by magnetic resonance imaging (MRI), each lesion must be \>10mm, 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. Received anti-CD70 drug treatment before screening;
•2. 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;
•3. 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 before cell reinfusion, or the last use of marketed drugs is less than 5 half-lives from cell reinfusion;
•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 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;
•4. Active infection or uncontrollable infection requiring systemic treatment within 1 week before screening;
•5. Malignant tumors other than the target tumor within 3 years before screening, except for the following: 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;
•6. Suffering from any of the following heart diseases:
+10 more criteria

Locations (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

Key Dates

Start Date

July 17, 2022

Primary Completion Date

July 17, 2024

Completion Date

July 17, 2025

Last Updated

August 18, 2023

Enrollment

ESTIMATED participants

Conditions

Metastatic TumorAdvanced Solid TumorRenal Cell CarcinomaOvarian CancerCervix Cancer

Interventions

CD70 CAR-T cells

BIOLOGICAL

CD70 CAR-T cells

BIOLOGICAL

Contacts

Quanli Gao, M.D

CONTACT

15038171966 zlyygql0855@zzu.edu.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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A Clinical Research About CD70-positive Advanced/Metastatic Solid Tumors Treated by CD70-targeted CAR-T

Inclusion Criteria

Exclusion Criteria

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