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New treatment option for Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma
Official title H3K27M-specific Immune Effector Cells Targeting DMG/DIPG
ClinicalTrials.gov ID: NCT07501156
What this study is testing
What is H3K27M-EIEs?
H3K27M-EIEs is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for diffuse midline glioma or diffuse intrinsic pontine glioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to assess the feasibility, safety and efficacy of H3K27M-specific engineered immune effector (EIE) therapy in patients with high-risk, H3K27M-positive diffuse midline glioma/diffuse intrinsic pontine glioma. Another goal of the study is to learn more about the function of the anti-H3K27M EIE cells and their persistency in patients.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 70
You may be able to join if
- Abilities to understand and the willingness to provide written informed consent;
- ≥ 2 and ≤ 70 years old;
- Recurrent or refractory diffuse midline glioma or diffuse intrinsic pontine glioma patients with confirmed H3K27M mutation and documented lesions...
- Karnofsky performance score (KPS) ≥ 60;
- Life expectancy \>3 months;
You likely can't join 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;
- Patients already actively enrolled in other immune cell clinical study; Patients, in the opinion of investigators, may not be eligible or not able to...
See the full eligibility criteria
- Abilities to understand and the willingness to provide written informed consent;
- ≥ 2 and ≤ 70 years old;
- Recurrent or refractory diffuse midline glioma or diffuse intrinsic pontine glioma patients with confirmed H3K27M mutation and documented lesions. Patients have received standard care of medication, such as gross total...
- 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...
- Peripheral blood absolute lymphocyte count must be above 0.8×10\^9/L;
- Satisfactory heart functions;
- 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...
- 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.