Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06394622

A Clinical Research About CD70-targeted CAR-NKT Cells Therapy Advanced Malignant Solid Tumors

Led by Fudan University · Updated on 2024-05-01

12

Participants Needed

1

Research Sites

115 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC729 in the treatment of advanced malignant solid tumors. Condition or disease:advanced malignant solid tumors. Intervention/treatment:Biological: CD70 CAR-NKT cells. Phase:I

CONDITIONS

Official Title

A Clinical Research About CD70-targeted CAR-NKT Cells Therapy Advanced Malignant Solid Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years
  • ECOG performance status of 0 or 1
  • Expected survival time longer than 3 months
  • Advanced malignant solid tumor confirmed by histology or cytology, recurrent or metastatic after at least second-line treatment
  • Tumor is CD70 positive by immunohistochemistry
  • At least one measurable tumor lesion at baseline per RECIST version 1.1
  • Adequate organ function including hematopoietic, renal, liver function, and coagulation parameters
  • Negative pregnancy test for women of childbearing age
  • Agreement to use effective contraception for both men and women
  • Signed informed consent indicating understanding and willingness to participate
Not Eligible

You will not qualify if you...

  • Received cell therapy within the previous one month
  • Risk of severe bleeding in esophageal cancer
  • Other malignant tumors within past 2 years except certain cured skin, bladder, or breast cancers
  • Leptomeningeal or central nervous system metastasis or significant CNS disease symptoms in past 6 months
  • Immunotherapy, targeted therapy, or chemotherapy within 2 weeks before cell infusion
  • Active hepatitis B, HIV positive, or hepatitis C positive
  • Active or uncontrolled infections
  • NYHA heart failure class 2 or higher, uncontrolled hypertension, recent myocarditis or myocardial infarction within 6 months
  • Unstable respiratory diseases including interstitial pneumonia
  • Uncontrolled ascites or pleural effusion
  • Active or uncontrolled autoimmune diseases like Crohn's disease, rheumatoid arthritis, or lupus
  • Use of systemic steroids or steroid inhalers
  • Pregnant or lactating females
  • Any condition deemed unsuitable for study participation by investigators

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

Fudan University

Shanghai, Shanghai Municipality, China

Actively Recruiting

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Research Team

J

Jian Zhang

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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