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CAR T-Cell Therapy for Pediatric Cancer
Study Summary
This trial is for patients ≤ 21 years old with relapsed/refractory B7-H3+ solid tumors, investigating the use of autologous T cells genetically engineered to express B7-H3-CARs. The study will evaluate the safety and maximum tolerated dose of B7-H3-CAR T cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am not pregnant or breastfeeding and can undergo or have had apheresis.I haven't taken any medication in the last 14 days that could affect my upcoming CAR T-cell therapy.I do not have any severe, uncontrolled infections.I haven't taken high doses of steroids in the week before my planned CAR T-cell therapy.My tumor is B7-H3 positive and can be measured.I am 21 years old or younger.Your disease is getting worse quickly, according to the study leaders.You are expected to live for more than 12 weeks.I have a stored sample of my white blood cells for T-cell production.You have been diagnosed with HIV.I do not have a severe infection like hepatitis B or C.You have had allergic reactions to products containing murine (mouse) proteins in the past.Your disease is getting worse very quickly according to the study doctors.I can do most activities but may need help.I have a history of HIV infection.You have a known weak immune system.I have a previously collected sample for T-cell production.
- Group 1: Treatment Phase
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has this treatment been explored in previous experimental investigations?
"Currently, 893 clinical trials are assessing the efficacy of this medication. Out of those active studies, 161 have reached Phase 3 status. While most trials for this treatment are being conducted in Philadelphia, Pennsylvania, 28460 locations around the world possess a research presence for it."
How many participants are currently being admitted to this research endeavor?
"Correct. According to records on clinicaltrials.gov, this study is actively recruiting participants since its launch date of June 29th 2022 and has been recently updated on the 30th. The trial requires 32 individuals at one medical centre."
Is this treatment a secure option for individuals?
"The safety of this treatment is rated a 1 on our scale because, as it stands in Phase 1, there are only minimal studies to back up its efficacy and risk-profile."
What indications does this treatment typically address?
"While this remedy is typically used for the treatment of multiple sclerosis, it may also be effective in treating leukaemia, myelocytic acute conditions and retinoblastoma as well as histiocytic lymphoma."
Are there still openings for participants in this clinical research?
"That is accurate. Clinicaltrials.gov holds the record that this clinical trial, initially posted on June 29th 2022, has remained open for participant recruitment. A total of 32 patients are desired from a single site."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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