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CAR T-cell Therapy
Multi-antigen T Cell Therapy for Brain Cancer (REMIND Trial)
Phase 1
Recruiting
Led By Eugene Hwang, MD
Research Sponsored by Catherine Bollard
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Organ function requirements: ANC ≥ 750/µL, Platelets ≥ 75K, Bilirubin ≤ 1.5x ULN, AST/ALT ≤ 5x ULN, Serum creatinine ≤ 1.0mg/dL or 1.5x ULN for age (whichever is higher)
Karnofsky/Lansky score of ≥ 60%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
REMIND Trial Summary
This trial is testing a new cancer treatment for patients with high-risk brain tumors. The treatment involves using the patient's own immune cells to kill the cancer cells. The trial will test the safety and feasibility of this new treatment.
Who is the study for?
This trial is for pediatric and adult patients aged 6 months to 80 years with high-risk central nervous system (CNS) tumors, including DIPG, glioma, medulloblastoma, and other aggressive malignancies. Participants must have stable neurologic deficits if present, meet organ function requirements like adequate blood counts and liver function tests, not be pregnant or breastfeeding, agree to use contraception if applicable, and have recovered from prior treatments.Check my eligibility
What is being tested?
The trial is testing TAA-T cells made from the patient's own blood to fight brain tumors. It has two groups: one for new cases of a specific tumor in the brainstem after radiotherapy (Group A), another for recurrent or hard-to-treat CNS tumors after standard therapy (Group B). The safety and ability to make these personalized immune cells quickly are being studied.See study design
What are the potential side effects?
As this is an early-phase trial focusing on safety and feasibility of TAA-T cell infusion against CNS tumors, potential side effects may include typical reactions related to immune therapies such as inflammation in various organs or tissues due to immune response but specific side effect profiles will be determined during the study.
REMIND Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood counts and liver/kidney functions are within required ranges.
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I can care for myself but may need occasional help.
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I am between 6 months and 80 years old.
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I have been diagnosed with a high-risk brain tumor.
REMIND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Product- Adverse Events
Secondary outcome measures
TAA-T responses
REMIND Trial Design
1Treatment groups
Experimental Treatment
Group I: TAA-TExperimental Treatment1 Intervention
Three different dosing schedules will be evaluated.
Dose Level One: 2 x 107 cells/m2 Dose Level Two: 4 x 107 cells/m2 Dose Level Three: 8 x 107 cells/m2
Group A patients (DIPG): The first TAA-T dose will be infused any time more than or equal to 14 days after completion of radiotherapy.
Group B patients (other recurrent/progressive/refractory CNS tumors): TAA-T will be infused any time more than or equal to 14 days after completing most recent course of conventional (non-investigational) therapy for their disease AND after appropriate washout periods as detailed in eligibility criteria.
Ideally, patients should not receive other systemic antineoplastic agents for at least 42 days after the infusion of TAA-T, although such treatment may be added if deemed critical for patient care by the attending physician.
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Who is running the clinical trial?
Catherine BollardLead Sponsor
13 Previous Clinical Trials
299 Total Patients Enrolled
Children's National Research InstituteOTHER
211 Previous Clinical Trials
208,125 Total Patients Enrolled
Eugene Hwang, MDPrincipal InvestigatorChildren's National Health System
4 Previous Clinical Trials
111 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of cancer.My blood counts and liver/kidney functions are within required ranges.My neurological symptoms have been stable for at least a week.I have had a condition where my lymphocytes grow abnormally.I can care for myself but may need occasional help.I am big enough to safely give the needed amount of blood for the test.I am taking less than 0.5 mg/kg/day of steroids.I do not have any infections that are currently uncontrolled.I have fully recovered from any side effects of my recent surgery.I am between 6 months and 80 years old.I (or my guardian) can understand and agree to the study's requirements.I have been diagnosed with a high-risk brain tumor.I haven't had cancer in the last 5 years, except for skin cancer.I haven't received certain immune system treatments within the last 28 days.My scans show a large tumor that affects my brain's structure.
Research Study Groups:
This trial has the following groups:- Group 1: TAA-T
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 could TAA-T be potentially hazardous for patients?
"The safety of TAA-T has been evaluated as a 1 given that this is an early stage trial and there is limited evidence supporting both efficacy and safety."
Answered by AI
How many applicants are being considered for this research venture?
"Affirmative. Clinicaltrials.gov reflects this medical study's ongoing recruitment of participants, which began on December 12th 2018 and was last updated on August 30th 2022. 32 patients are needed from a single health facility for the trial to move forward."
Answered by AI
Could individuals aged 55 and above partake in this clinical experiment?
"Per the selection criteria, this clinical trial is open to individuals between half a year and 8 decades of age. Moreover, 82 studies are available for minors while 351 studies cater to seniors aged 65 or older."
Answered by AI
What qualifications are necessary to gain admittance into the research?
"To be eligible for this medical trial, patients must have a neoplasm in their brain and be between 6 months old to 80 years of age. A cohort of 32 individuals are being sought out by the researchers."
Answered by AI
Is there any room left for potential participants in this research endeavor?
"Affirmative. As evidenced on clinicaltrials.gov, this study is open to recruitment and was initially published in December 12th 2018 before being updated on August 30th 2022. The trial requires 32 volunteers from 1 site."
Answered by AI
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