Your session is about to expire
← Back to Search
CAR T-cell Therapy
CAR T-Cell Therapy for Neuroblastoma (GRAIN Trial)
Phase 1
Waitlist Available
Led By Andras A. Heczey, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
PROCUREMENT
Karnofsky/Lansky score of 60% or greater
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
GRAIN Trial Summary
This trial is for people with relapsed or refractory neuroblastoma who will receive iC9-GD2 T cells after lymphodepletion with fludarabine and cyclophosphamide.
Who is the study for?
This trial is for children with high-risk neuroblastoma that's come back or didn't respond to treatment. They should have normal liver and kidney function, be stable after previous treatments, not have certain allergies, and must not be on immunosuppressive drugs. A key requirement is having T-cells modified to fight cancer ready for infusion.Check my eligibility
What is being tested?
The study tests a new gene therapy using T cells engineered to target neuroblastoma more effectively by living longer in the body. It includes lymphodepletion chemotherapy (cyclophosphamide and fludarabine) followed by these special T cells plus pembrolizumab to counteract substances released by tumors that weaken immune responses.See study design
What are the potential side effects?
Possible side effects include reactions from the genetically modified T cells or chemotherapy like fatigue, nausea, low blood counts leading to infection risk; pembrolizumab can cause immune-related issues such as inflammation of organs but varies among patients.
GRAIN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may need occasional help.
Select...
My kidney function tests are within acceptable limits.
Select...
Pembrolizumab is available for my treatment.
Select...
My neuroblastoma is high risk and has either come back or not gone away.
Select...
My T-cells are modified to target my cancer effectively.
GRAIN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicities at 6 weeks post T cell infusion
Secondary outcome measures
Change in serum cytokine and chemokine levels
Time to progression of disease
To evaluate the expansion and persistence of 3rd generation iC9-GD2 T cells
GRAIN Trial Design
3Treatment groups
Experimental Treatment
Group I: iC9-GD2 T cells,Cytoxan,Fludara,KeytrudaExperimental Treatment4 Interventions
Fresh T cells will be given IV over 5-10 mins. There is a possibility for additional doses of iC9-GD2 T cells.
Group II: iC9-GD2 T Cells - frozen - CLOSEDExperimental Treatment1 Intervention
The cells will be given IV over 5-10 minutes. There is a possibility for additional doses of iC9-GD2 T cells.
Group III: iC9-GD2 T Cells - fresh - CLOSEDExperimental Treatment1 Intervention
The cells will be given IV over 5-10 minutes. There is a possibility for additional doses of iC9-GD2 T cells.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytoxan
2007
Completed Phase 3
~1460
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,169 Total Patients Enrolled
13 Trials studying Neuroblastoma
294 Patients Enrolled for Neuroblastoma
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,806 Total Patients Enrolled
11 Trials studying Neuroblastoma
252 Patients Enrolled for Neuroblastoma
The Methodist Hospital Research InstituteOTHER
271 Previous Clinical Trials
80,364 Total Patients Enrolled
3 Trials studying Neuroblastoma
152 Patients Enrolled for Neuroblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had an allergic reaction in the past to products containing murine protein.My cancer is growing quickly.I have recovered from my last chemotherapy, except for stable chronic conditions.Pembrolizumab is available for my treatment.I have had heart enlargement or lung issues on scans but my heart function is normal or my lung issues are not cancer.I can care for myself but may need occasional help.My thyroid hormone levels are normal, and if I'm on medication, my dose has been stable for at least a month.My T-cells are modified to target my cancer effectively.My tumor might block my airways.I am currently taking drugs that suppress my immune system.I had a severe reaction to a PD-1 inhibitor like pembrolizumab.My kidney function tests are within acceptable limits.You are currently taking experimental medications for other studies.You are expected to live for at least 12 more weeks.My neuroblastoma is high risk and has either come back or not gone away.I am currently receiving or need treatment.I had severe side effects from cyclophosphamide or fludarabine.
Research Study Groups:
This trial has the following groups:- Group 1: iC9-GD2 T Cells - fresh - CLOSED
- Group 2: iC9-GD2 T Cells - frozen - CLOSED
- Group 3: iC9-GD2 T cells,Cytoxan,Fludara,Keytruda
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.
How deleterious is the use of iC9-GD2 T cells to human health?
"The safety of iC9-GD2 T Cells has been rated a 1 on our scale because this is an initial Phase I trial. There is thus limited evidence to support its efficacy and security at present."
Answered by AI
What maladies are iC9-GD2 T cells commonly employed to treat?
"iC9-GD2 T cells are usually used to treat lymphoma and non-Hodgkin's, but they can also be beneficial for other malignancies like melanomas of the skin, recurrent cervical cancer, and leukemia."
Answered by AI
Could you please provide a numerical estimate of the participants involved in this research endeavor?
"Unfortunately, this research project is not taking on new trial participants at the present time. It was first posted in August 2013 and last updated in January 2022. If you are looking for alternative studies, there are 161 open studies involving neuroblastoma sufferers as well as 1,817 clinical trials accepting patients with iC9-GD2 T Cells."
Answered by AI
Has there been precedent for using iC9-GD2 T cells in clinical trials?
"At present, 1817 research trials investigating iC9-GD2 T cells are ongoing. Of those experiments, 281 have entered Phase 3 in the clinical trial process. While Philadelphia is the epicentre for these studies, 63417 sites across America are running tests related to this treatment modality."
Answered by AI
Are there any vacancies available for participants in this experiment?
"This clinical trial is not currently open to participants, as the last update on 1/19/2022 indicates. If you are seeking other trials, 161 studies related to neuroblastoma and 1817 regarding iC9-GD2 T cells are actively looking for recruits."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger