Health Trials

About this trial

This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CD70-positive advanced/metastatic solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.

Eligibility criteria

Qualifiers

Age ≥18 years old, male or female;

Histopathology or cytology (paraffin section or fresh biopsy tumor tissue specimen) diagnosed as advanced/metastatic solid tumor (positive tumor CD70 expression (tumor CD70 positive (IHC 3+) confirmed by histology or pathology));

Failure or intolerance after standard treatment (disease progression or intolerance such as surgery, chemotherapy, radiotherapy, targeted therapy, etc.), and there is currently no effective treatment;

According to the RECIST version 1.1 standard, at least one target lesion with measurable diameter and evaluable, measurable lesions are defined as: extranodal CT scan long diameter ≥ 10mm, lymph node lesions CT scan short diameter ≥ 15mm, scan slice thickness Not larger than 5mm, and has not received local treatment;

Disqualifiers

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-proven progression ≥4 weeks after the end of treatment before they can be enrolled;

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;

Received anti-tumor therapy such as chemotherapy and targeted therapy within 2 weeks or at least 5 half-lives (whichever is shorter) before apheresis;

Trial design

Treatments tested in this trial

  • CD70 CAR-T cells
  • CD70 CAR-T cells

Treatment groups

30 Participants
are divided into 2 treatment groups

Locations

1
First affiliated hospital, Zhejiang University310006, HangzhouZhejiang, China

Sponsors and collaborators

Weijia Fang, MD

Lead sponsor

Zhejiang University

Sponsor institution

Chongqing Precision Biotech Co., Ltd

Collaborator

Source ClinicalTrials.gov