DLL3-targeted CAR-T therapy for DLL3-positive brain tumors
4sCAR-DLL3 CAR-T Therapy Targeting Brain Tumors
This trial tests DLL3-directed CAR-T cells in people aged 2–70 with recurrent or refractory DLL3-positive brain tumors such as cerebellar glioblastoma, DIPG, or DMG to see if the treatment is safe, feasible, and can reduce tumor burden.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 2 Years to 70 Years |
| Sex | All |
| Sponsor | Shenzhen Geno-Immune Medical Institute Academic / other |
| Drugs / interventions | chemotherapy, CAR-T, chimeric antigen receptor |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT07180927 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2 trial uses autologous CAR-T cells engineered to recognize DLL3, a protein commonly expressed on certain aggressive brain tumors but minimally on normal tissue. Eligible participants undergo leukapheresis to collect T cells, which are modified and then infused back into the patient, with monitoring for safety, persistence of the CAR-T cells, and preliminary signs of anti-tumor activity. The study enrolls patients with recurrent or refractory disease and measurable lesions who meet defined organ function and performance status criteria. Outcomes include feasibility of manufacturing, adverse events, CAR-T cell persistence, and early measures of tumor response.
Who should consider this trial
Good fit: Ideal candidates are people aged 2–70 with recurrent or refractory DLL3-positive brain tumors who have measurable disease, adequate organ function, Karnofsky performance score ≥60, life expectancy >3 months, and are on low-dose or no dexamethasone at leukapheresis.
Not a fit: Patients whose tumors do not express DLL3, who have poor performance status, significant organ dysfunction, uncontrolled infections, or require high-dose steroids are unlikely to benefit from this therapy.
Why it matters
Potential benefit: If successful, this approach could offer a new targeted immunotherapy option that shrinks DLL3-positive brain tumors and potentially extends survival for patients with few current treatments.
How similar studies have performed: DLL3 has been targeted by other experimental therapies with mixed results and DLL3-directed CAR-T is a relatively new approach with encouraging preclinical data but limited clinical evidence so far.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. abilities to understand and the willingness to provide written informed consent; 2. patients are ≥ 2 and ≤ 70 years old; 3. 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; 4. Karnofsky performance score (KPS) ≥ 60; 5. life expectancy \>3 months; 6. 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; 7. peripheral blood absolute lymphocyte count must be above 0.8×10\^9/L; 8. satisfactory heart functions; 9. patients must be willing to follow the instructions of doctors; 10. 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. Exclusion Criteria: 1. a prior history of gliadel implantation 4 weeks before this study start or currently receiving antibody based therapies; 2. HIV positive; 3. tuberculosis infection not under control; 4. history of autoimmune disease, or other diseases require long-term administration of steroids or immunosuppressive therapies; 5. history of allergic disease, or allergy to immune cells or study product excipients; 6. 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.
Where this trial is running
Shenzhen, Guangdong
- Shenzhen Geno-immuno Medical Institute — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Lung-Ji Chang, PhD
- Email: c@szgimi.org
- Phone: +86 0755-86573763
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.