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Tests treatment safety and results for DIPG Brain Tumor
Official title Safety and Efficacy of Loco-regional B7H3 IL-7Ra CAR T Cell in DIPG
ClinicalTrials.gov ID: NCT06221553
What this study is testing
What is B7H3 specific CAR T cell with IL-7Ra signaling domain?
B7H3 specific CAR T cell with IL-7Ra signaling domain is an investigational medicine, being studied as a potential treatment for dipg brain tumor.
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
- A Phase 1 clinical trial to evaluate the safety and early efficacy of CAR T-cell with IL-7Ra signal targeting B7H3 in children with diffuse intrinsic pontine glioma (DIPG) patients after complete standard treatments.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- Participants must have diffuse intrinsic pontine glioma at any timepoint following completion of standard radiotherapy
- Age 1-18 years
- Sex: Male or female
- CNS reservoir catheter, such as an Ommaya or Rickham catheter, present in the proper location for CNS-directed therapy
- Performance status: Lansky or Karnofsky score \>= 60
You likely can't join if
- Presence of \>= grade 3 cardiac dysfunction or symptomatic arrythmia requiring intervention
- Presence of primary immunodeficiency or bone marrow failure syndrome
- Presence of clinical and/or radiographic evidence of impending herniation of CNS
- Presence of \> Grade 3 dysphagia
- History of active malignancy other than nonmelanoma skin cancer and carcinoma in situ (e.g., cervix, bladder, breast).
- Presence of uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure...
See the full eligibility criteria
- Participants must have diffuse intrinsic pontine glioma at any timepoint following completion of standard radiotherapy
- Age 1-18 years
- Sex: Male or female
- CNS reservoir catheter, such as an Ommaya or Rickham catheter, present in the proper location for CNS-directed therapy
- Performance status: Lansky or Karnofsky score \>= 60
- Life expectancy \>= 8 weeks
- Normal organ function: 7.1 AST (SGOT) \ =90%
- Prior therapy wash-out before planned leukapheresis 8.1 \>= 7 days post last chemotherapy/biologic therapy administration 8.2 3 half-lives or 30 days, whichever is shorter after the last dose of antitumor antibody...
- Participants and/or legal guardians must have the ability to understand and willingness to sign a written informed consent and/or assent document
- Presence of \>= grade 3 cardiac dysfunction or symptomatic arrythmia requiring intervention
- Presence of primary immunodeficiency or bone marrow failure syndrome
- Presence of clinical and/or radiographic evidence of impending herniation of CNS
- Presence of \> Grade 3 dysphagia
- History of active malignancy other than nonmelanoma skin cancer and carcinoma in situ (e.g., cervix, bladder, breast).
- Presence of uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities, or...
- Pregnant or breastfeeding women were excluded from this study because CAR-T-cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a...
- Serologic status reflecting active HIV, hepatitis B or C infection. Participants who are positive for hepatitis B core antibody, hepatitis B surface antigen or hepatitis C antibody must have negative PCR prior to...
The study team makes the final eligibility decision.
Where it's taking place
- Bangkok, Pathumwan, Thailand
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, 1 year to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bangkok, Pathumwan, Thailand. 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.