Actively Recruiting

Phase 1
Age: 18Years - 70Years
All Genders
NCT04969354

Clinical Study of CAIX-targeted CAR-T Cells in the Treatment of Advanced Renal Cell Carcinoma

Led by The Affiliated Hospital of Xuzhou Medical University · Updated on 2021-07-20

20

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

T

The Affiliated Hospital of Xuzhou Medical University

Lead Sponsor

X

Xuzhou Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is an experimental study to evaluate the safety and efficacy of CAR T cells targeting CAIX in the treatment of advanced renal cancer.

CONDITIONS

Official Title

Clinical Study of CAIX-targeted CAR-T Cells in the Treatment of Advanced Renal Cell Carcinoma

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged from 18 to 70 years old
  • ECOG performance status score of 2 or less
  • Advanced or metastatic renal cell carcinoma with prior first-line and second-line targeted therapy
  • Prior immunotherapy with PD-1/L1 and two or fewer regimens
  • Unable to tolerate targeted therapy or immunotherapy
  • Measurable or evaluable lesions present
  • Adequate liver function with ALT/AST less than 3 times the upper limit of normal
  • Kidney function with creatinine less than 220 bcmol/L
  • Lung function with oxygen saturation of 95% or higher
  • Cardiac function with left ventricular ejection fraction 40% or higher
  • Voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • Infectious diseases such as HIV, active hepatitis B or C, or active tuberculosis
  • Insufficient transfection (<10%) or poor amplification (<5 times) of targeted lymphocytes
  • Abnormal vital signs preventing cooperation with examinations
  • Mental or psychological disorders preventing cooperation with treatment or evaluations
  • Severe allergies, especially to IL-2
  • Systemic or severe local infections requiring anti-infection treatment
  • Dysfunction of major organs including heart, lung, brain, liver, or kidney
  • Presence of other tumors
  • Any other medical reasons deemed by doctors to prevent inclusion in treatment

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

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China, 221000

Actively Recruiting

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Research Team

H

Hailong Li, M.D/Ph.D

CONTACT

Q

Qing Zhang, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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