NeuroblastomaPhase 1GRAINNCT01822652
3rd Generation GD-2 Chimeric Antigen Receptor and iCaspase Suicide Safety Switch, Neuroblastoma, GRAIN
A Phase 1 study testing iC9-GD2 T Cells - frozen, iC9-GD2 T Cells - fresh and Cytoxan in people with Neuroblastoma, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
Subjects that have relapsed or refractory neuroblastoma are invited to take part in this gene transfer research study. We have found from previous research that we can put a new gene called a chimeric antigen receptor (CAR) into T cells that will make them recognize neuroblastoma cells and kill them. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- iC9-GD2 T Cells - frozen, iC9-GD2 T Cells - fresh and Cytoxan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2013to Oct 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PROCUREMENT
- High risk neuroblastoma with persistent or relapsed disease
- Life expectancy of at least 12 weeks
- Karnofsky/Lansky score of 60% or greater
- Absence of HAMA prior to enrollment (only in patients that have been previously treated with murine antibodies)
- Informed consent and assent (as applicable) obtained from parent/guardian and child
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- TREATMENT:
- High risk neuroblastoma with persistent or relapsed disease
- Life expectancy of at least 12 weeks
- Karnofsky/Lansky score of 60% or greater
- Patients must have an ANC greater than or equal to 500, platelet count greater than or equal to 20,000
- Pulse Ox greater than or equal to 90% on room air
- AST and ALT less than 5 times the upper limit of normal
- Total bilirubin less than 3 times the upper limit of normal
- Serum creatinine less than 3 times upper limit of normal. Creatinine clearance is needed for patients with creatinine greater than 1.5 times upper limit of normal
- TSH normal for age. Patients using thyroid medication to facilitate a euthyroid state must be on a stable dose for at least 1 month prior to planned infusion
- Recovered from acute effects of all prior chemotherapy. If some effects of therapy have become chronic (i.e., treatment associated thrombocytopenia), the patient must be clinically stable and meet all other eligibility criteria
- Absence of human anti-mouse antibodies (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies
- Patients must have autologous transduced activated T-cells with greater than or equal to 20% expression of GD2
- Pembrolizumab available for infusion
- Informed consent and assent (as applicable) obtained from parent/guardian and child
Who cannot join
- PROCUREMENT:
- Rapidly progressive disease
- History of hypersensitivity to murine protein containing products
- TREATMENT:
- Rapidly progressive disease
- Currently receiving other investigational drugs
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- History of hypersensitivity to murine protein containing products
- History of cardiomegaly or bilateral pulmonary infiltrates on chest radiograph or CT. However, patients with cardiomegaly on imaging may be enrolled if they have an assessment of cardiac function (i.e., ECHO or MUGA) within 3 weeks of starting protocol therapy that is within normal limits. Additionally, patients with bilateral pulmonary infiltrates on imaging may be enrolled if the lesions are not consistent with active neuroblastoma (i.e., negative on functional imaging with PET or MIBG, or by pathologic assessment).
- Evidence of tumor potentially causing airway obstruction
- Patients who are pregnant, lactating, or unwilling to use birth control
- Patients currently receiving immunosuppressive drugs such as corticosteroids, tacrolimus or cyclosporine
- Patients previously experienced severe toxicity from cyclophosphamide or fludarabine
- Severe previous toxicity from pembrolizumab or other PD-1 targeted antibody
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Houston Methodist Hospital
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
About this study
Official title: Autologous Activated T-Cells Transduced With A 3rd Generation GD-2 Chimeric Antigen Receptor And iCaspase9 Safety Switch Administered To Patients With Relapsed Or Refractory Neuroblastoma (GRAIN)
Subjects that have relapsed or refractory neuroblastoma are invited to take part in this gene transfer research study.
We have found from previous research that we can put a new gene called a chimeric antigen receptor (CAR) into T cells that will make them recognize neuroblastoma cells and kill them. In a previous clinical trial, we used a CAR that recognizes GD2, a protein found on almost all neuroblastoma cells (GD2-CAR). We put this gene into T cells and gave them back to patients that had neuroblastoma. The infusions were safe and in patients with disease at the time of their infusion, the time to progression was longer if we could find GD2 T cells in their blood for more than 6 weeks. Because of this, we think that if T cells are able to last longer, they may have a better chance of killing neuroblastoma tumor cells.
Read more
Therefore, in this study we will add new genes to the GD2 T cells that can cause the cells to live longer. These new genes are called CD28 and OX40. The purpose of this study will be to determine the highest dose of iC9-GD2-CD28-OX40 (iC9-GD2) T cells that can safely be given to patients with relapsed/refractory neuroblastoma.
In other clinical studies using T cells, some investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. This is called lymphodepletion and we think that it will allow the T cells we infuse to expand and stay longer in the body, and potentially kill cancer cells more effectively.
The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and fludarabine.
Additionally, to effectively kill the tumor cells, it is important that the T cells are able to survive and expand in the tumor. Recent studies have shown that solid tumors release a substance (PD1) that can inhibit T cells after they arrive into the tumor tissue. In an attempt to overcome the effect of PD1 in neuroblastoma we will also give a medication called pembrolizumab.
Read the detailed description
We will make iC9-GD2 T cells by infecting normal T cells with a retroviral vector containing the iC9-GD2 gene. After the new gene has been put into the T cells, the cells will be tested to make sure that they kill GD2-positive neuroblastoma cells and then will be either given fresh or frozen until the patient is ready for their infusion.
First, patients will receive cyclophosphamide and fludarabine intravenously (through a needle inserted into a vein or your port-a-cath) for 2 days and then fludarabine alone for one day (Day -4, -3,-2). On the next day (Day -1) patients will receive the drug called pembrolizumab intravenously. Finally on Day 0 patients will be given an infusion of iC9 GD2 T cells into the vein through an IV line at the assigned dose.
The iC9-GD2 T cell infusion will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or Houston Methodist Hospital. The infusion will take between 5 and 10 minutes. Patients may need to stay in Houston for up to 4 weeks after the infusion so we can monitor them for side effects.
On Day 21 (at the time of the week 3 visit), if the treatment was well tolerated, patients will receive another dose of pembrolizumab intravenously.
There will be follow-up visits every 1-2 weeks during the first 2 months and then they will be spaced out over a total of 15 years. Because the cells are modified with a new gene we must follow patients for at least 15 years to see if there are any long term side effects of gene transfer. During the visits, we will see how the patients are doing and during certain time points we will obtain extra blood samples to learn more about the way the iC9-GD2 T cells are working and how long they last in the body.
After disease re-evaluation, if disease has not gotten worse, or if in the future it seems that patient might benefit and they have not had a severe side effect caused by the infusion of their iC9-GD2 T cells, patients may be eligible to receive up to 2 additional doses of their T cells. Each dose will be at the same dose level as their first infusion and separated by at least 6 weeks such that we can make sure patients have no severe side effects between infusions. If patients receive additional doses of iC9-GD2 T-cells, they may need to stay in Houston for up to 4 weeks after the infusion as well so we can monitor them for side effects. If there were no severe side effects from pembrolizumab, patients will receive pembrolizumab again with the iC9 GD2 T cells on the day before the T cell injection and 21 days after the T cells.
- Conditions
- Neuroblastoma
- Being tested
- iC9-GD2 T Cells - frozen, iC9-GD2 T Cells - fresh, Cytoxan, Fludara, Keytruda
- Keywords
- Neuroblastoma, Solid tumor, Neuroblastoma-specific immunotherapy targeting GD2, CAR T cells, Gene Therapy, Relapsed, Refractory
- Medical subject headings
- Neuroblastoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iC9-GD2 T Cells - frozenGenetic
Subjects will receive the iC9-GD2 T cells through an IV over 5 to 10 minutes.
Subjects will receive one of the following dose levels (cells/m2):
- Dose Level 1 = 1 x 10^7
- Dose Level 2 = 1 x 10^8
- Dose Level 3 = 2 x 10^8
Six weeks after the infusion, patients will have a disease re-evaluation. If the disease has not gotten worse AND they have not had a severe side effect caused by the infusion of the iC9-GD2 T cells, the subject may be eligible to receive up to 2 additional doses of T cells. Each dose will be at the same dose level as the first infusion, if available, and separated by at least 6 weeks.
iC9-GD2 T Cells - freshGenetic
For subjects who will receive a fresh T cell product:
- Dose Level 1 = 1 x 10^8
- Dose Level 2 = 1.5 x 10^8
- Dose Level 3 = 2 x 10^8
Six weeks after the infusion, patients will have a disease re-evaluation. If the disease has not gotten worse AND they have not had a severe side effect caused by the infusion of the iC9-GD2 T cells, the subject may be eligible to receive up to 2 additional doses of T cells. Each dose will be at the same dose level as the first infusion, if available, and separated by at least 6 weeks.
CytoxanDrug
Also called Cyclophosphamide
Cyclophosphamide (500 mg/m2/day x 2 days, for patients <12 kg = 16.7 mg/kg/day x 2 days)
FludaraDrug
Also called Fludarabine
Fludarabine (30 mg/m2/day x 3 days, for patients <12 kg = 1 mg/kg/day x 3 days)
KeytrudaDrug
Also called Pembrolizumab
Pembrolizumab (2 mg/kg on Day -1 and on Day 21).
iC9-GD2 T cellsGenetic
For subjects who will receive a fresh T cell product:
- Dose Level 1 = 1.5 x 10^8
- Dose Level 2 = 2 x 10^8
Six weeks after the infusion, patients will have a disease re-evaluation. If the disease has not gotten worse AND they have not had a severe side effect caused by the infusion of the iC9-GD2 T cells, the subject may be eligible to receive up to 2 additional doses of T cells. Each dose will be at the same dose level as the first infusion, if available, and separated by at least 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| iC9-GD2 T Cells - fresh - CLOSED | Experimental | The cells will be given IV over 5-10 minutes. There is a possibility for additional doses of iC9-GD2 T cells. Receives: Genetic: iC9-GD2 T Cells - fresh |
| iC9-GD2 T Cells - frozen - CLOSED | Experimental | The cells will be given IV over 5-10 minutes. There is a possibility for additional doses of iC9-GD2 T cells. Receives: Genetic: iC9-GD2 T Cells - frozen |
| iC9-GD2 T cells,Cytoxan,Fludara,Keytruda | Experimental | Fresh T cells will be given IV over 5-10 mins. There is a possibility for additional doses of iC9-GD2 T cells. Receives: Drug: Cytoxan; Drug: Fludara; Drug: Keytruda; Genetic: iC9-GD2 T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicities at 6 weeks post T cell infusion
We will measure and assess the adverse events to find the maximum tolerated dose of iC9-GD2 T cells and the safety profile of iC9-GD2 T cells.
Measured: 6 weeks after infusion of the last dose of iC9-GD2 T cells to all patients on the study
Secondary outcomes (3)
To evaluate the expansion and persistence of 3rd generation iC9-GD2 T cells
We will determine the expansion and functional persistence of iC9-GD2 T cells in the peripheral blood of patients using transgene detection by quantitative real-time PCR and response of transgenic cells to tumor antigen and to dimerizing drug in vitro.
Measured: 15 years
Time to progression of disease
To describe the overall response rate and disease-free survival.
Measured: 15 years
Change in serum cytokine and chemokine levels
The changes in patients' serum cytokine and chemokine levels after iC9-GD2 T cell infusion
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2015
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute, Solving Kids' Cancer, The Evan Foundation, National Cancer Institute (NCI), Kids Cancer Research Foundation
- Responsible party
- Principal investigator, David Steffin, MD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822652
- Sponsor's protocol ID
- H-31493 GRAIN
- Other IDs
- P01CA094237
- Acronym
- GRAIN
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2013
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Activated T-Cells Transduced With A 3rd Generation GD-2 Chimeric Antigen Receptor And iCaspase9 Safety Switch Administered To Patients With Relapsed Or Refractory Neuroblastoma (GRAIN)
- ClinicalTrials.gov ID
- NCT01822652
- Acronym / sponsor ID
- GRAIN / H-31493 GRAIN
- Conditions
- Neuroblastoma
- Keywords
- Neuroblastoma, Solid tumor, Neuroblastoma-specific immunotherapy targeting GD2, CAR T cells, Gene Therapy, Relapsed, Refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute, Solving Kids' Cancer, The Evan Foundation, National Cancer Institute (NCI), Kids Cancer Research Foundation
- Study start
- Aug 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Oct 2030 (estimated)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects that have relapsed or refractory neuroblastoma are invited to take part in this gene transfer research study.
We have found from previous research that we can put a new gene called a chimeric antigen receptor (CAR) into T cells that will make them recognize neuroblastoma cells and kill them. In a previous clinical trial, we used a CAR that recognizes GD2, a protein found on almost all neuroblastoma cells (GD2-CAR). We put this gene into T cells and gave them back to patients that had neuroblastoma. The infusions were safe and in patients with disease at the time of their infusion, the time to progression was longer if we could find GD2 T cells in their blood for more than 6 weeks. Because of this, we think that if T cells are able to last longer, they may have a better chance of killing neuroblastoma tumor cells.
Therefore, in this study we will add new genes to the GD2 T cells that can cause the cells to live longer. These new genes are called CD28 and OX40. The purpose of this study will be to determine the highest dose of iC9-GD2-CD28-OX40 (iC9-GD2) T cells that can safely be given to patients with relapsed/refractory neuroblastoma.
In other clinical studies using T cells, some investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. This is called lymphodepletion and we think that it will allow the T cells we infuse to expand and stay longer in the body, and potentially kill cancer cells more effectively.
The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and fludarabine.
Additionally, to effectively kill the tumor cells, it is important that the T cells are able to survive and expand in the tumor. Recent studies have shown that solid tumors release a substance (PD1) that can inhibit T cells after they arrive into the tumor tissue. In an attempt to overcome the effect of PD1 in neuroblastoma we will also give a medication called pembrolizumab.
Detailed description
We will make iC9-GD2 T cells by infecting normal T cells with a retroviral vector containing the iC9-GD2 gene. After the new gene has been put into the T cells, the cells will be tested to make sure that they kill GD2-positive neuroblastoma cells and then will be either given fresh or frozen until the patient is ready for their infusion.
First, patients will receive cyclophosphamide and fludarabine intravenously (through a needle inserted into a vein or your port-a-cath) for 2 days and then fludarabine alone for one day (Day -4, -3,-2). On the next day (Day -1) patients will receive the drug called pembrolizumab intravenously. Finally on Day 0 patients will be given an infusion of iC9 GD2 T cells into the vein through an IV line at the assigned dose.
The iC9-GD2 T cell infusion will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or Houston Methodist Hospital. The infusion will take between 5 and 10 minutes. Patients may need to stay in Houston for up to 4 weeks after the infusion so we can monitor them for side effects.
On Day 21 (at the time of the week 3 visit), if the treatment was well tolerated, patients will receive another dose of pembrolizumab intravenously.
There will be follow-up visits every 1-2 weeks during the first 2 months and then they will be spaced out over a total of 15 years. Because the cells are modified with a new gene we must follow patients for at least 15 years to see if there are any long term side effects of gene transfer. During the visits, we will see how the patients are doing and during certain time points we will obtain extra blood samples to learn more about the way the iC9-GD2 T cells are working and how long they last in the body.
After disease re-evaluation, if disease has not gotten worse, or if in the future it seems that patient might benefit and they have not had a severe side effect caused by the infusion of their iC9-GD2 T cells, patients may be eligible to receive up to 2 additional doses of their T cells. Each dose will be at the same dose level as their first infusion and separated by at least 6 weeks such that we can make sure patients have no severe side effects between infusions. If patients receive additional doses of iC9-GD2 T-cells, they may need to stay in Houston for up to 4 weeks after the infusion as well so we can monitor them for side effects. If there were no severe side effects from pembrolizumab, patients will receive pembrolizumab again with the iC9 GD2 T cells on the day before the T cell injection and 21 days after the T cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iC9-GD2 T Cells - fresh - CLOSED | Experimental | Genetic: iC9-GD2 T Cells - freshThe cells will be given IV over 5-10 minutes. There is a possibility for additional doses of iC9-GD2 T cells. |
| iC9-GD2 T Cells - frozen - CLOSED | Experimental | Genetic: iC9-GD2 T Cells - frozenThe cells will be given IV over 5-10 minutes. There is a possibility for additional doses of iC9-GD2 T cells. |
| iC9-GD2 T cells,Cytoxan,Fludara,Keytruda | Experimental | Drug: Cytoxan, Drug: Fludara, Drug: Keytruda, Genetic: iC9-GD2 T cellsFresh T cells will be given IV over 5-10 mins. There is a possibility for additional doses of iC9-GD2 T cells. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- PROCUREMENT
- High risk neuroblastoma with persistent or relapsed disease
- Life expectancy of at least 12 weeks
- Karnofsky/Lansky score of 60% or greater
- Absence of HAMA prior to enrollment (only in patients that have been previously treated with murine antibodies)
Key exclusion criteria (13 listed)
- Rapidly progressive disease
- History of hypersensitivity to murine protein containing products
- Rapidly progressive disease
- Currently receiving other investigational drugs
- History of hypersensitivity to murine protein containing products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iC9-GD2 T Cells - frozenSubjects will receive the iC9-GD2 T cells through an IV over 5 to 10 minutes. Subjects will receive one of the following dose levels (cells/m2): * Dose Level 1 = 1 x 10^7 * Dose Level 2 = 1 x 10^8 * Dose Level 3 = 2 x 10^8 Six weeks after the infusion, patients will have a disease re-evaluation. If the disease has not gotten worse AND they have not had a severe side effect caused by the infusion of the iC9-GD2 T cells, the subject may be eligible to receive up to 2 additional doses of T cells. Each dose will be at the same dose level as the first infusion, if available, and separated by at least 6 weeks. | Genetic | iC9-GD2 T Cells - frozen - CLOSED |
| iC9-GD2 T Cells - freshFor subjects who will receive a fresh T cell product: * Dose Level 1 = 1 x 10^8 * Dose Level 2 = 1.5 x 10^8 * Dose Level 3 = 2 x 10^8 Six weeks after the infusion, patients will have a disease re-evaluation. If the disease has not gotten worse AND they have not had a severe side effect caused by the infusion of the iC9-GD2 T cells, the subject may be eligible to receive up to 2 additional doses of T cells. Each dose will be at the same dose level as the first infusion, if available, and separated by at least 6 weeks. | Genetic | iC9-GD2 T Cells - fresh - CLOSED |
| CytoxanAlso: CyclophosphamideCyclophosphamide (500 mg/m2/day x 2 days, for patients <12 kg = 16.7 mg/kg/day x 2 days) | Drug | iC9-GD2 T cells,Cytoxan,Fludara,Keytruda |
| FludaraAlso: FludarabineFludarabine (30 mg/m2/day x 3 days, for patients <12 kg = 1 mg/kg/day x 3 days) | Drug | iC9-GD2 T cells,Cytoxan,Fludara,Keytruda |
| KeytrudaAlso: PembrolizumabPembrolizumab (2 mg/kg on Day -1 and on Day 21). | Drug | iC9-GD2 T cells,Cytoxan,Fludara,Keytruda |
| iC9-GD2 T cellsFor subjects who will receive a fresh T cell product: * Dose Level 1 = 1.5 x 10^8 * Dose Level 2 = 2 x 10^8 Six weeks after the infusion, patients will have a disease re-evaluation. If the disease has not gotten worse AND they have not had a severe side effect caused by the infusion of the iC9-GD2 T cells, the subject may be eligible to receive up to 2 additional doses of T cells. Each dose will be at the same dose level as the first infusion, if available, and separated by at least 6 weeks. | Genetic | iC9-GD2 T cells,Cytoxan,Fludara,Keytruda |
Primary outcome
Dose limiting toxicities at 6 weeks post T cell infusion
Time frame: 6 weeks after infusion of the last dose of iC9-GD2 T cells to all patients on the study
We will measure and assess the adverse events to find the maximum tolerated dose of iC9-GD2 T cells and the safety profile of iC9-GD2 T cells.
3 secondary outcomes
To evaluate the expansion and persistence of 3rd generation iC9-GD2 T cells
Time frame: 15 years
Time to progression of disease
Time frame: 15 years
Change in serum cytokine and chemokine levels
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing iC9-GD2 T Cells - frozen, iC9-GD2 T Cells - fresh and Cytoxan in people with Neuroblastoma, run by Baylor College of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicities at 6 weeks post T cell infusion (time frame: 6 weeks after infusion of the last dose of iC9-GD2 T cells to all patients on the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.