Relapsed NeuroblastomaPhase 1NCT07211737
NKG2D.Zeta-NK Cell Conditioning With C7R.GD2.CAR-T Cells for Patients With Relapsed or Refractory Osteosarcoma or Neuroblastoma
A Phase 1 study testing i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells in people with Relapsed Neuroblastoma and Refractory Neuroblastoma, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to find the largest safe dose of i15.NKG2D.zeta-NK cells in combination with C7R.GD2.CAR-T cells, and additionally to evaluate how long they can be detected in patients' blood and what affect they have on patients' cancer. Read more about this study
- Who is it for?
- Ages 1 year to 24 years
- Conditions the study is for
- Relapsed Neuroblastoma, Refractory Neuroblastoma, Relapsed Osteosarcoma
- What is being tested?
- i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to Apr 2044
- 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 1 year to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
PROCUREMENT INCLUSION:
- Patients with Neuroblastoma that have persistent disease after standard treatment or have relapsed/refractory disease. Or Patients with Osteosarcoma that have persistent disease after standard treatment or have relapsed/refractory disease.
- Karnofsky/Lansky score of 60% or greater.
- Informed consent and assent (as applicable) obtained from parent/guardian and child.
- Greater than 1 year of age.
PROCUREMENT EXCLUSION:
- History of hypersensitivity to murine protein-containing products.
- Known presence of Human Anti-Mouse Antibodies (HAMA).
- Active autoimmune disease (requiring immunosuppressive treatment in the past 6 months).
- Primary brain tumor or known brain metastases (on evaluation by MIBG and/or PET if applicable, CT/MRI/LP not required).
TREATMENT INCLUSION:
- Patients with Neuroblastoma that have persistent disease after standard treatment or have relapsed/refractory disease. Or Patients with Osteosarcoma that have persistent disease after standard treatment or have relapsed/refractory disease.
- Karnofsky/Lansky score of 50% or greater
- Pulse Ox greater than or equal to 90% on room air
- AST less than 5 times upper limit of normal (less than 10 times upper normal if known with metastatic liver disease)
- Total bilirubin less than 3 times the upper limit of normal
- Serum creatinine less than 3 times upper limit of normal
- Available autologous T-cells with greater than or equal to 20% expressing GD2.CAR
- Informed consent and assent (as applicable) obtained from parent/guardian and child.
- Greater than 1 year of age.
- Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study.
TREATMENT EXCLUSION:
- History of hypersensitivity to murine protein containing products (patients who have undergone desensitization and successful re-challenge without hypersensitivity reaction are eligible).
- Known presence of Human Anti-Mouse Antibodies (HAMA).
- Tumor potentially causing airway obstruction per investigator discretion.
- Pregnancy or lactation / will not use birth control methods.
- Currently receiving immunosuppressive drugs (patients on low dose corticosteroids are eligible: less than 0.25 mg/kg/day of prednisone/equivalent).
- Primary brain tumor or known brain metastases (on evaluation by MIBG and/or PET if applicable, CT/MRI/LP not required).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Robin Parihar, MD, 832-824-4746, rxpariha@texaschildrens.org
About this study
Official title: (INCITE-ON) Phase I Study of i15.NKG2D.Zeta-NK Cell Conditioning in the Tumor Micro-environment in Combination With C7R.GD2.CAR-T for the Treatment of Patients With Relapsed or Refractory Osteosarcoma or Neuroblastoma
The purpose of this study is to find the largest safe dose of i15.NKG2D.zeta-NK cells in combination with C7R.GD2.CAR-T cells, and additionally to evaluate how long they can be detected in patients' blood and what affect they have on patients' cancer.
Patients eligible for this study have neuroblastoma or osteosarcoma that expresses a substance on the cancer cells called GD2. This cancer has either come back after treatment or did not respond to the standard or other investigational treatments or therapies used to treat it. There is no standard treatment for these types of advanced cancers at this time. This is a gene transfer research study using special immune cells called NK cells and T cells. NK cells and T cells are types of white blood cell that help the body fight infection.
Read more
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: NK cells and T cells. T cells are special infection-fighting blood cells that can kill cells infected with viruses and tumor cells. NK cells, another kind of infection-fighting cell, can recognize a wide range of cells in distress, including tumor cells and cells that help protect tumor cells in the cancer environment. Both NK cells and T cells have been used individually to treat patients with cancers. They have shown promise, but have not been strong enough individually to cure most patients.
Investigators have found from previous research that we can put a new gene into T cells that will make them recognize GD2, a substance found on almost all neuroblastoma and osteosarcoma cells. We can also put a new gene into NK cells that help them fight the tumor environment. Investigators know that T cells and NK cells need substances called cytokines to survive but the cells do not get enough cytokines after infusion into the body; therefore, the investigators have added the genes C7R and IL15 into the T and NK cells, respectively, to give each cell a constant supply of cytokine that helps them to survive longer.
The C7R.GD2.CAR-T cells and i15.NKG2D.zeta-NK cells are investigational products not approved by the Food and Drug Administration.
Read the detailed description
To make the T cells, the investigators will take patient's blood and stimulate it with growth factors that make T cells grow. Investigators will use a retrovirus to insert the GD2-targeting chimeric antigen receptor (CAR) into the T cells. To make NK cells, investigators will take blood from healthy donors and stimulate them with growth factors that make NK cells grow. Investigators will also use a retrovirus to insert the tumor environment-targeting NK receptor, called NKG2D.zeta, into the NK cells.
The cells generated will be frozen and stored to give back to the patient. Because patients will have received cells with a new gene in them, patients will be followed for a total of 15 years to see if there are any long term side effects of gene transfer.
Patients will be assigned a dose of i15.NKG2D.zeta-NK cells. The assigned dose of cells is based on body weight and height.
In this study, patients will receive the i15.NKG2D.zeta-NK and C7R.GD2.CAR-T cells. On Day -5, the patient will be given an injection of i15.NKG2D.zeta-NK cells into the vein through an IV line at the assigned dose. Before receiving the NK cell infusion, the patient may be given a dose of Benadryl (diphenhydramine) and Tylenol (acetaminophen). The infusion will take between 1 to 10 minutes. Investigators will then monitor the patient in the clinic for about 3 hours. The study was designed to not give doses of lymphodepletion chemotherapy prior to the i15.NKG2D.zeta-NK and C7R.GD2.CAR-T cells. However, some patients may need to receive lymphodepletion chemotherapy prior to the NK cell infusion, based on preliminary study results.
This will be followed by an injection of C7R.GD2.CAR-T cells on Day 0. Before receiving the infusion, the patient may be given doses of Benadryl (diphenhydramine) and Tylenol (acetaminophen). The infusion will take between 1 to 10 minutes. Investigators will monitor the patient in the clinic for about 3 hours. The treatment will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital. The patient may need to stay in Houston for up to 4 weeks after the infusion so we can monitor for side effects.
The patient will have follow-up visits after the T cell infusion at day -3, day +3, weeks 1, 2, 3, 4, and 8, then at months 3, 6, 9, an d 12, and then twice a year for the next 4 years and annually for the next 10 years. The patient will also have scheduled disease evaluations after the T cell injection at week 6 and then as clinically needed.
Medical test before treatment--
Before being treated, the patient will receive a series of standard medical tests:
- Physical exam
- Blood tests to measure blood cells, kidney and liver function
- Measurements of the tumor by routine imaging studies and/or bone marrow evaluation. We will use the imaging studies that have been used in the past to best assess the tumor: Computed Tomography (CT) scan, Magnetic Resonance Imaging (MRI), Position Emission Tomography (PET/CT), Bone Scan, and/or MIBG scan.
- Pulmonary Function Tests (PFT) to see how well the patient's lungs are working.
Medical tests during and after treatment--
The patient will receive standard medical tests when they are getting the infusions and afterwards:
- Physical exams
- Blood tests to measure blood cells, kidney and liver function
- Measurements of the tumor by routine imaging studies and/or bone marrow evaluation 6 weeks after the infusion (if the bone marrow showed tumor before the infusion).
To learn more about the way the i15.NKG2D.zeta-NK cells and C7R.GD2.CAR-T cells are working and how long they last in the body, an extra amount of blood will be obtained on the day of the NK-cell infusion and the T-cell infusion and at the end of the NK-cell and T-cell infusions, 1, 2, 3, 4, and 8 weeks after the T-cell infusion and every 3 months for the 1st year, every 6 months for the next 4 years and annually for the next 10 years. The amount of blood taken will be based on the patient's weight with up to a maximum of 60 mL (12 teaspoons) of blood to be obtained at any one time. For children, the total amount of blood drawn will not be more than 3 mL (less than 1 teaspoon) per 1 kg of body weight on any one day. This volume is considered safe, but may be decreased if patient is anemic (has a low red blood cell count).
During the time points listed above, if the i15.NKG2D.zeta-NK cells or C7R.GD2.CAR-T cells are found in the patient's blood at a certain amount, an extra 5 mL (about 1 teaspoon) of blood may need to be collected for additional testing.
If the patient has a procedure where tumor samples are obtained, like a repeat bone marrow evaluation or tumor biopsy, the investigators will request a sample to be used for research purposes.
The patient will receive supportive care for any acute or chronic toxicities, including blood components or antibiotics, and other intervention as medically appropriate.
- Conditions
- Relapsed Neuroblastoma, Refractory Neuroblastoma, Relapsed Osteosarcoma, Refractory Osteosarcoma
- Being tested
- i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells
- Keywords
- Gene Therapy, CAR T cells, Neuroblastoma, Osteosarcoma, Immunotherapy, chimeric antigen receptor, NK Cell
- Medical subject headings
- Neuroblastoma, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cellsGenetic
Dose Level 1: 3 x 10^8/m^2 of i15.NKG2D.zeta NK cells and 3 x 10^7/m^2 of C7R.GD2.CAR T cells given 5 days later.
i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cellsGenetic
Dose Level 2: 6 x 10^8/m^2 of i15.NKG2D.zeta NK cells and 3 x 10^7 cells/m^2 of C7R.GD2.CAR T cells given 5 days later.
i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cellsGenetic
Dose Level 3: 12 x 10^8/m^2 of i15.NKG2D.zeta NK cells and 3 x 10^7 cells/m^2 of C7R.GD2.CAR T cells given 5 days later.
| Study group | Role | What they receive |
|---|---|---|
| i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells | Experimental | Three dose levels will be evaluated. This is a dose escalating trial which will infuse doses of i15.NKG2D.zeta NK cells followed by a fixed dose of C7R.GD2.CAR T cells 5 days later. Receives: Genetic: i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT) rate
Proportion of participants with DLTs related to the combination of NK cell and T cell infusions evaluated as per the NCI CTCAE v5.0 criteria
Measured: 4 weeks post-CAR-T cell infusion
Maximum tolerated dose (MTD) of i15.NKG2D.zeta-NK cells when given in combination with C7R.GD2.CAR-T cells
The dose level of infused NK cells for which the DLT rate is approximately 0.3
Measured: 4 weeks post CAR-T infusion of the last participant
Secondary outcomes (2)
Objective response rate (ORR)
Proportion of participants with complete response (CR) or partial response (PR) according to RECIST v1.1 criteria and/or MIBG evaluation (for neuroblastoma)
Measured: 6 weeks after CAR-T infusion
Cytokine release syndrome (CRS) grade
Any grade CRS as evaluated by established clinical CRS Grading Scale
Measured: 4 weeks post CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start15 Jul 2026
- Primary completionApr 2029 (estimated)
- Study completionApr 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
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
- Responsible party
- Principal investigator, Robin Parihar, MD, PhD, Baylor College of Medicine
- Investigators
- Leander D Timothy, MD, Principal investigator, Baylor College of MedicineShoba A Navai, MD, Principal investigator, Baylor College of MedicineStephanie L Fetzko, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211737
- Sponsor's protocol ID
- H-55743 INCITE-ON
- Status last verified
- Jul 2026
- First submitted
- 4 Sep 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (INCITE-ON) Phase I Study of i15.NKG2D.Zeta-NK Cell Conditioning in the Tumor Micro-environment in Combination With C7R.GD2.CAR-T for the Treatment of Patients With Relapsed or Refractory Osteosarcoma or Neuroblastoma
- ClinicalTrials.gov ID
- NCT07211737
- Acronym / sponsor ID
- H-55743 INCITE-ON
- Conditions
- Relapsed Neuroblastoma, Refractory Neuroblastoma, Relapsed Osteosarcoma, Refractory Osteosarcoma
- Keywords
- Gene Therapy, CAR T cells, Neuroblastoma, Osteosarcoma, Immunotherapy, chimeric antigen receptor, NK Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2044 (estimated)
- First posted
- 8 Oct 2025 (actual)
- 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.
The purpose of this study is to find the largest safe dose of i15.NKG2D.zeta-NK cells in combination with C7R.GD2.CAR-T cells, and additionally to evaluate how long they can be detected in patients' blood and what affect they have on patients' cancer.
Patients eligible for this study have neuroblastoma or osteosarcoma that expresses a substance on the cancer cells called GD2. This cancer has either come back after treatment or did not respond to the standard or other investigational treatments or therapies used to treat it. There is no standard treatment for these types of advanced cancers at this time. This is a gene transfer research study using special immune cells called NK cells and T cells. NK cells and T cells are types of white blood cell that help the body fight infection.
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: NK cells and T cells. T cells are special infection-fighting blood cells that can kill cells infected with viruses and tumor cells. NK cells, another kind of infection-fighting cell, can recognize a wide range of cells in distress, including tumor cells and cells that help protect tumor cells in the cancer environment. Both NK cells and T cells have been used individually to treat patients with cancers. They have shown promise, but have not been strong enough individually to cure most patients.
Investigators have found from previous research that we can put a new gene into T cells that will make them recognize GD2, a substance found on almost all neuroblastoma and osteosarcoma cells. We can also put a new gene into NK cells that help them fight the tumor environment. Investigators know that T cells and NK cells need substances called cytokines to survive but the cells do not get enough cytokines after infusion into the body; therefore, the investigators have added the genes C7R and IL15 into the T and NK cells, respectively, to give each cell a constant supply of cytokine that helps them to survive longer.
The C7R.GD2.CAR-T cells and i15.NKG2D.zeta-NK cells are investigational products not approved by the Food and Drug Administration.
Detailed description
To make the T cells, the investigators will take patient's blood and stimulate it with growth factors that make T cells grow. Investigators will use a retrovirus to insert the GD2-targeting chimeric antigen receptor (CAR) into the T cells. To make NK cells, investigators will take blood from healthy donors and stimulate them with growth factors that make NK cells grow. Investigators will also use a retrovirus to insert the tumor environment-targeting NK receptor, called NKG2D.zeta, into the NK cells.
The cells generated will be frozen and stored to give back to the patient. Because patients will have received cells with a new gene in them, patients will be followed for a total of 15 years to see if there are any long term side effects of gene transfer.
Patients will be assigned a dose of i15.NKG2D.zeta-NK cells. The assigned dose of cells is based on body weight and height.
In this study, patients will receive the i15.NKG2D.zeta-NK and C7R.GD2.CAR-T cells. On Day -5, the patient will be given an injection of i15.NKG2D.zeta-NK cells into the vein through an IV line at the assigned dose. Before receiving the NK cell infusion, the patient may be given a dose of Benadryl (diphenhydramine) and Tylenol (acetaminophen). The infusion will take between 1 to 10 minutes. Investigators will then monitor the patient in the clinic for about 3 hours. The study was designed to not give doses of lymphodepletion chemotherapy prior to the i15.NKG2D.zeta-NK and C7R.GD2.CAR-T cells. However, some patients may need to receive lymphodepletion chemotherapy prior to the NK cell infusion, based on preliminary study results.
This will be followed by an injection of C7R.GD2.CAR-T cells on Day 0. Before receiving the infusion, the patient may be given doses of Benadryl (diphenhydramine) and Tylenol (acetaminophen). The infusion will take between 1 to 10 minutes. Investigators will monitor the patient in the clinic for about 3 hours. The treatment will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital. The patient may need to stay in Houston for up to 4 weeks after the infusion so we can monitor for side effects.
The patient will have follow-up visits after the T cell infusion at day -3, day +3, weeks 1, 2, 3, 4, and 8, then at months 3, 6, 9, an d 12, and then twice a year for the next 4 years and annually for the next 10 years. The patient will also have scheduled disease evaluations after the T cell injection at week 6 and then as clinically needed.
Medical test before treatment--
Before being treated, the patient will receive a series of standard medical tests:
- Physical exam
- Blood tests to measure blood cells, kidney and liver function
- Measurements of the tumor by routine imaging studies and/or bone marrow evaluation. We will use the imaging studies that have been used in the past to best assess the tumor: Computed Tomography (CT) scan, Magnetic Resonance Imaging (MRI), Position Emission Tomography (PET/CT), Bone Scan, and/or MIBG scan.
- Pulmonary Function Tests (PFT) to see how well the patient's lungs are working.
Medical tests during and after treatment--
The patient will receive standard medical tests when they are getting the infusions and afterwards:
- Physical exams
- Blood tests to measure blood cells, kidney and liver function
- Measurements of the tumor by routine imaging studies and/or bone marrow evaluation 6 weeks after the infusion (if the bone marrow showed tumor before the infusion).
To learn more about the way the i15.NKG2D.zeta-NK cells and C7R.GD2.CAR-T cells are working and how long they last in the body, an extra amount of blood will be obtained on the day of the NK-cell infusion and the T-cell infusion and at the end of the NK-cell and T-cell infusions, 1, 2, 3, 4, and 8 weeks after the T-cell infusion and every 3 months for the 1st year, every 6 months for the next 4 years and annually for the next 10 years. The amount of blood taken will be based on the patient's weight with up to a maximum of 60 mL (12 teaspoons) of blood to be obtained at any one time. For children, the total amount of blood drawn will not be more than 3 mL (less than 1 teaspoon) per 1 kg of body weight on any one day. This volume is considered safe, but may be decreased if patient is anemic (has a low red blood cell count).
During the time points listed above, if the i15.NKG2D.zeta-NK cells or C7R.GD2.CAR-T cells are found in the patient's blood at a certain amount, an extra 5 mL (about 1 teaspoon) of blood may need to be collected for additional testing.
If the patient has a procedure where tumor samples are obtained, like a repeat bone marrow evaluation or tumor biopsy, the investigators will request a sample to be used for research purposes.
The patient will receive supportive care for any acute or chronic toxicities, including blood components or antibiotics, and other intervention as medically appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells | Experimental | Genetic: i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cellsThree dose levels will be evaluated. This is a dose escalating trial which will infuse doses of i15.NKG2D.zeta NK cells followed by a fixed dose of C7R.GD2.CAR T cells 5 days later. |
Who may qualify
- Ages
- 1 year to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cellsDose Level 1: 3 x 10^8/m^2 of i15.NKG2D.zeta NK cells and 3 x 10^7/m^2 of C7R.GD2.CAR T cells given 5 days later. | Genetic | i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells |
| i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cellsDose Level 2: 6 x 10^8/m^2 of i15.NKG2D.zeta NK cells and 3 x 10^7 cells/m^2 of C7R.GD2.CAR T cells given 5 days later. | Genetic | i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells |
| i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cellsDose Level 3: 12 x 10^8/m^2 of i15.NKG2D.zeta NK cells and 3 x 10^7 cells/m^2 of C7R.GD2.CAR T cells given 5 days later. | Genetic | i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells |
Primary outcome
Dose-limiting toxicity (DLT) rate
Time frame: 4 weeks post-CAR-T cell infusion
Proportion of participants with DLTs related to the combination of NK cell and T cell infusions evaluated as per the NCI CTCAE v5.0 criteria
Maximum tolerated dose (MTD) of i15.NKG2D.zeta-NK cells when given in combination with C7R.GD2.CAR-T cells
Time frame: 4 weeks post CAR-T infusion of the last participant
The dose level of infused NK cells for which the DLT rate is approximately 0.3
2 secondary outcomes
Objective response rate (ORR)
Time frame: 6 weeks after CAR-T infusion
Cytokine release syndrome (CRS) grade
Time frame: 4 weeks post CAR-T infusion
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 21 Jul 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.
Leander D Timothy, MD principal investigator
Baylor College of Medicine
Shoba A Navai, MD principal investigator
Baylor College of Medicine
Stephanie L Fetzko, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells in people with Relapsed Neuroblastoma and Refractory Neuroblastoma, run by Baylor College of Medicine at 1 site 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?
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: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Robin Parihar, MD, PhD (832-824-4746, rxpariha@texaschildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) rate (time frame: 4 weeks post-CAR-T cell infusion). The study lists 2 primary outcomes in all. 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 21 Jul 2026.