DLL3 CAR-T Therapy Targeting Brain Tumors

NCT07180927 | Recruiting Phase 1

• 1 other identifier: GIMI-IRB-25003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Glioblastoma of Cerebellum

Keywords

CAR-T; Glioblastoma; DLL3

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events.

  Determine the toxicity profile the 4SCAR DLL3 cells with Common Toxicity Criteria for Adverse Effects version 4.0

  6 months

Secondary Outcomes (4)

• Anti-tumor effects

  1 year

• Anti-tumor effects

  1 year

• The expansion of 4SCAR DLL3 T cells

  1 year

• The persistence of 4SCAR DLL3 T cells

  1 year

Study Arms (1)

4SCAR-DLL3 T Cell Therapy treating DLL3 positive glioblastoma

EXPERIMENTAL

Infusion of 4SCAR-DLL3 T cells at 10\^6 cells/kg body weight via intravenous route

Biological: 4SCAR DLL3 T cells

Interventions

4SCAR DLL3 T cells BIOLOGICAL

Infusion of 4SCAR DLL3 T cells at 10\^6 cells/kg body weight via intravenous route

4SCAR-DLL3 T Cell Therapy treating DLL3 positive glioblastoma

Eligibility Criteria

• Age: 2 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• abilities to understand and the willingness to provide written informed consent;
• patients are ≥ 2 and ≤ 70 years old;
• recurrent or refractory brain tumor patients with measurable lesions. Patients have received standard care of medication, such as gross total resection with concurrent radio-chemotherapy (\~54 - 60 Gy, TMZ). Patients must either not be receiving dexamethasone or receiving ≤ 4 mg/day at the time of leukopheresis;
• Karnofsky performance score (KPS) ≥ 60;
• life expectancy \>3 months;
• satisfactory bone marrow, liver and kidney functions as defined by the following: absolute neutrophile count ≥ 1500/mm\^3; hemoglobin \> 10 g/dL; platelets \> 100000 /mm\^3; Bilirubin \< 1.5×ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2.5×ULN; creatinine \< 1.5×ULN;
• peripheral blood absolute lymphocyte count must be above 0.8×10\^9/L;
• satisfactory heart functions;
• patients must be willing to follow the instructions of doctors;
• women of reproductive potential (between 15 and 49 years old) must have a negative pregnancy test within 7 days of study start. Male and female patients of reproductive potential must agree to use birth control during the study and 3 months post study.

You may not qualify if:

• a prior history of gliadel implantation 4 weeks before this study start or currently receiving antibody based therapies;
• HIV positive;
• tuberculosis infection not under control;
• history of autoimmune disease, or other diseases require long-term administration of steroids or immunosuppressive therapies;
• history of allergic disease, or allergy to immune cells or study product excipients;
• patients already actively enrolled in other immune cell clinical study; patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

Sponsors & Collaborators

• Shenzhen Geno-Immune Medical Institute: lead

Study Sites (1)

Shenzhen Geno-immuno Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Lung-Ji Chang, PhD

CONTACT

+86 0755-86573763; c@szgimi.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)