Actively Recruiting

Phase 1
Phase 2
Age: 2Years - 70Years
All Genders
NCT07180927

DLL3 CAR-T Therapy Targeting Brain Tumors

Led by Shenzhen Geno-Immune Medical Institute · Updated on 2025-09-18

30

Participants Needed

1

Research Sites

211 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to assess the feasibility, safety and efficacy of Delta-like ligand 3 (DLL3)-specific CAR-T cell therapy in patients with DLL3 positive brain tumors including glioblastomas and diffused intrinsic pontine or midline gliomas (DIPG or DMG). Another goal of the study is to learn more about the function of the anti-DLL3 CAR-T cells and their persistency in patients.

CONDITIONS

Official Title

DLL3 CAR-T Therapy Targeting Brain Tumors

Who Can Participate

Age: 2Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and provide written informed consent
  • Age between 2 and 70 years
  • Recurrent or refractory brain tumor patients with measurable lesions who have received standard care such as surgery and chemoradiotherapy
  • Patients not receiving dexamethasone or receiving 4 mg/day or less at the time of leukapheresis
  • Karnofsky performance score of 60 or higher
  • Life expectancy greater than 3 months
  • Adequate bone marrow, liver, and kidney function as defined by specific blood counts and lab values
  • Peripheral blood absolute lymphocyte count above 0.8 x 10^9/L
  • Satisfactory heart function
  • Willingness to follow doctors' instructions
  • Women of reproductive potential (ages 15 to 49) must have a negative pregnancy test within 7 days before study start
  • Male and female patients of reproductive potential must agree to use birth control during the study and for 3 months after
Not Eligible

You will not qualify if you...

  • Prior gliadel implantation within 4 weeks before study start or currently receiving antibody-based therapies
  • HIV positive
  • Uncontrolled tuberculosis infection
  • History of autoimmune disease or other conditions requiring long-term steroids or immunosuppressive therapy
  • History of allergic disease or allergy to immune cells or study product components
  • Active enrollment in another immune cell clinical study
  • Investigator judgment that the patient may not be eligible or able to comply with the study

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

Shenzhen Geno-immuno Medical Institute

Shenzhen, Guangdong, China, 518000

Actively Recruiting

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Research Team

L

Lung-Ji Chang, PhD

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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