B7-H3.CD28Z.CART in CNS Neoplasms (NCT07390539) | Clinical Trial Compass
Not Yet RecruitingPhase 1
B7-H3.CD28Z.CART in CNS Neoplasms
United States70 participantsStarted 2026-07
Plain-language summary
The purpose of this research study is to test the safety and effectiveness of a cell therapy at different doses for children and young adults with recurrent or progressive brain tumors. Recurrent/recurred means a tumor that has gone away and then came back. This cell therapy is called B7- H3.CD28Z.CART, referred to as B7-H3 CAR T cells. B7-H3 is a protein that is over-expressed on many tumor cells, making it a good target for cancer cell therapy.
The names of the study investigational therapies involved in this study are:
* Fludarabine (a type of chemotherapy)
* Cyclophosphamide (a type of chemotherapy)
* B7-H3 CAR T cells (a type of cellular therapy)
Who can participate
Age range
2 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
-Eligible CNS embryonal tumor types include:
-Eligible CNS embryonal tumor types include:
-Measurable disease (contrast-enhancing or non-enhancing tumor)
-Non-measurable disease (tumor that is too small to be accurately measured)
--Craniospinal irradiation, whole brain radiation therapy, or radiation therapy to \>50% of the pelvis or spine \>28 days prior to enrollment
--Focal irradiation (small port) \>14 days prior to enrollment
-Adequate bone marrow function
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Manufacturing Success Rate of Autologous B7-H3.CD28Z CAR T Cells
Timeframe: Participants will receive the CART cell infusion on Day 0.
2
Maximum Tolerated Dose (MTD) of B7-H3.CD28Z.CART Cells
Timeframe: 28 days
3
Recommended Phase 2 Dose (RP2D) of B7-H3.CD28Z.CART Cells