Your session is about to expire
← Back to Search
CAR T-cell Therapy
CAR T-Cell Therapy for Brain Cancer
Phase 1
Recruiting
Led By Reena Thomas, MD, PhD
Research Sponsored by Crystal Mackall, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing if it is safe to give a certain medication to people with a certain type of brain cancer. The trial will see if there are any side effects from the medication and if it is possible to manufacture it.
Who is the study for?
Adults aged 18-75 with recurrent high-grade glioblastoma, IDH wild-type, who have completed standard therapy and show tumor progression. They must be stable on low-dose steroids, have good organ function and performance status, not pregnant or breastfeeding, willing to use contraception, able to follow study procedures at Stanford Health Care.Check my eligibility
What is being tested?
The trial is testing B7-H3CART cells delivered directly into the brain of patients with recurrent glioblastoma. It's a Phase I study focusing on safety and how well the treatment can be made using a '3+3 dose escalation' method where doses are increased slowly in small groups.See study design
What are the potential side effects?
Potential side effects may include immune reactions due to CAR T-cell therapy such as fever, fatigue, headache, muscle pain; neurological symptoms like confusion or seizures; and possible risks from local administration into the brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) or Recommended phase 2 dose (RP2D)
Number of successful manufacturing product (B7-H3CART) that met minimum assigned dose level range
Secondary outcome measures
Cumulative Safety of B7-H3CART
Immunotherapy Response Assessment in Neuro-oncology (iRANO) in subjects with recurrent IDH wild-type GBM
Median overall survival (OS)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dose escalationExperimental Treatment1 Intervention
Participants will follow a standard 3+3 dose escalation design up to four dose levels, repeated every 28 days up to 6 doses.
Group II: Dose ExpansionExperimental Treatment1 Intervention
After maximum tolerated dose and/or recommended phase 2 dose (MTD/RP2D) is established, subjects will be enrolled at the RP2D to further explore safety and conduct a preliminary assessment of benefit.
Find a Location
Who is running the clinical trial?
Crystal Mackall, MDLead Sponsor
4 Previous Clinical Trials
178 Total Patients Enrolled
Reena Thomas, MD, PhDPrincipal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctors believe most of my tumor can be surgically removed.I have HIV or hepatitis but it's under control.I have had a bone marrow or stem cell transplant.I am currently on blood thinners.I use no more than 4 mg of decadron daily.I have used Avastin for recurrent disease or radiation damage.I have previously received CAR therapy.I am between 18 and 75 years old.I have an autoimmune disease or primary immunodeficiency that has affected my organs or needed strong medication in the last 2 years.I can care for myself but may need occasional help.I've had a break from cancer treatments long enough to meet the trial's requirements.I had cancer before, but it was treated over 3 years ago or is not considered a threat.I have severe brain pressure or seizures that are not controlled.I do not have any major health issues like uncontrolled high blood pressure, heart disease, severe lung problems, kidney failure, liver issues, another type of cancer (except for certain skin cancers), or a serious infection.My high-grade brain tumor has returned or worsened after initial treatment.I do not have any serious infections, or if I do, they are under control with treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Dose escalation
- Group 2: Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent might B7-H3CART pose a risk to people participating in the experiment?
"Given the limited data collected in Phase 1 of this study, our team at Power provided B7-H3CART with a score of 1 on its assessment scale for safety."
Answered by AI
What is the current cohort size for this study?
"Affirmative. According to the clinicaltrials.gov website, this medical trial is presently on the search for 39 participants from a single location. It was first published on July 12th 2022 and recently updated on July 22nd of the same year."
Answered by AI
Are there still enrolment opportunities for this clinical research project?
"According to the records on clinicaltrials.gov, recruitment for this medical trial is still taking place. It was initially published in July 12th 2022 and underwent its last update two weeks ago on July 22nd of the same year."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger