Health TrialsbyHealthPanel

DLL3 CAR-T Therapy Targeting Brain Tumors

ConditionGlioblastoma of Cerebellum
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age2-70
SponsorShenzhen Geno-Immune Medical Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 4SCAR DLL3 T cells

    Biological/Vaccine

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: 4SCAR-DLL3 T Cell Therapy treating DLL3 positive glioblastomaExperimental treatment 1 intervention

Trial outcomes

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

Time frame
6 months

Secondary outcomes

1

Anti-tumor effects

Objective responses (complete response (CR) are assessed by the Response Evaluation Criteria in Glioblastoma (RECIST) v1.1 criteria.

Time frame
1 year
2

Anti-tumor effects

Objective responses partial response (PR)) are assessed by the Response Evaluation Criteria in Glioblastoma (RECIST) v1.1 criteria.

Time frame
1 year
3

The expansion of 4SCAR DLL3 T cells

Scale of CAR copies for efficacy

Time frame
1 year
4

The persistence of 4SCAR DLL3 T cells

Scale of tumor burden for efficacy

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen Geno-Immune Medical Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: