Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05518253

A Clinical Study of CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors

Led by Weijia Fang, MD · Updated on 2025-05-31

30

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

W

Weijia Fang, MD

Lead Sponsor

C

Chongqing Precision Biotech Co., Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Clinical Study of CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, male or female
  • Diagnosed with advanced or metastatic solid tumor with CD70-positive expression confirmed by pathology
  • Disease progression or intolerance after standard treatments with no effective current treatment
  • Presence of at least one measurable target lesion according to RECIST 1.1 criteria
  • ECOG performance status between 0 and 2
  • Expected survival time longer than 12 weeks
  • No serious mental disorders
  • Adequate organ function including hematopoietic, cardiac, renal, liver function, and oxygen saturation above 92%
  • Suitable for apheresis or venous blood collection without contraindications
  • Agreement to use reliable contraception methods for 1 year after CAR-T infusion
  • Signed informed consent indicating understanding and willingness to participate
Not Eligible

You will not qualify if you...

  • Prior treatment with anti-CD70 drugs before screening
  • Active or symptomatic central nervous system or meningeal metastases at screening
  • Participation in other interventional clinical studies recently or recent use of unmarketed or marketed drugs within specified timeframes
  • Recent anti-tumor therapies such as chemotherapy, targeted therapy, or corticosteroids above specified doses
  • Receipt of live attenuated vaccines within 4 weeks before screening
  • Active or uncontrolled infections requiring systemic treatment within 1 week before screening
  • Malignant tumors other than the target tumor within past 3 years, except certain treated cases
  • Serious heart conditions including advanced congestive heart failure, recent myocardial infarction, significant arrhythmias, or severe cardiomyopathy
  • Active or uncontrolled autoimmune diseases
  • Positive tests for certain infections including hepatitis B, hepatitis C, HIV, syphilis, or CMV
  • History of venous thromboembolic events requiring ongoing anticoagulation or significant sequelae
  • Poorly controlled hypertension despite treatment
  • Pregnant or breastfeeding women or those planning to conceive within 1 year after CAR-T infusion
  • Any other condition deemed inappropriate by investigators for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, China, 310006

Actively Recruiting

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Research Team

W

Weijia Fang, M.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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A Clinical Study of CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors | DecenTrialz