A Phase 1 interventional study of AGAR T cells in Liver Cancer, Rhabdomyosarcoma and Malignant Rhabdoid Tumor, sponsored by Baylor College of Medicine. Active, not recruiting at 1 site in United States. Open to participants aged 1 Year to 21 Years. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Baylor College of Medicine · Phase 1, Interventional, and Treatment
Patients may be considered if the cancer has come back, has not gone away after standard treatment or the patient cannot receive standard treatment. This research study uses special immune system cells called AGAR T cells, a new experimental treatment.
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: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients.
Investigators have found from previous research that they can put a new gene (a tiny part of what makes-up DNA and carries your traits) into T cells that will make them recognize cancer cells and kill them. In the lab, investigators made several genes called a chimeric antigen receptor (CAR), from an antibody called GPC3. The antibody GPC3 recognizes a protein found solid tumors including pediatric liver cancers. This CAR is called GPC3-CAR. To make this CAR more effective, investigators also added a gene that includes IL15. IL15 is a protein that helps CAR T cells grow better and stay in the blood longer so that they may kill tumors better. The mixture of GPC3-CAR and IL15 killed tumor cells better in the laboratory when compared with CAR T cells that did not have IL15 .This study will test T cells that investigators made (called genetic engineering) with GPC3-CAR and the IL15 (AGAR T cells) in patients with GPC3-positive solid tumors such as yours.
T cells made to carry a gene called iCasp9 can be killed when they encounter a specific drug called Rimiducid. The investigators will insert the iCasp9 and IL15 together into the T cells using a virus that has been made for this study. The drug (Rimiducid) is an experimental drug that has been tested in humans with no bad side-effects. The investigators will use this drug to kill the T cells if necessary due to side effects.
This study will test T cells genetically engineered with a GPC3-CAR and IL15 (AGAR T cells) in patients with GPC3-positive solid tumors.
The AGAR T cells are an investigational product not approved by the Food and Drug Administration.
The purpose of this study is to find the biggest dose of AGAR T cells that is safe, to see how long they last in the body, to learn what the side effects are and to see if the AGAR T cells will help people with GPC3-positive solid tumors.
Approximately 15-24 subjects will participate in the treatment part of this study.
Maximum of 180 mL of blood (not exceeding 3ml/kg/day) is collected from patients to grow the T cells and a retrovirus (a special virus that can insert the GPC3 CAR gene into the T cells) is used to genetically engineer them. After the CAR gene was put into the T cells, the investigators make sure that they are able to kill GPC3 positive solid tumor cells in the laboratory.
LYMPHODEPLETION CHEMOTHERAPY:
Several studies suggest that the infused T cells need room to be able to increase in numbers/multiply and accomplish their functions and that this may not happen if there are too many other T cells in circulation . Because of that, participants will receive treatment with lymphodepletion chemotherapy. This chemotherapy means the participant will receive both cyclophosphamide (Cytoxan) and fludarabine. Participants will receive these drugs for 3 days before receiving the T-cell infusion. These drugs will decrease the numbers of the participants own T cells before the investigators infuse the AGAR T cells.
WHAT THE INFUSION WILL BE LIKE:
After making these cells, they will be frozen. If the patient agrees to participate in this study, at the time the patient is scheduled to be treated, the cells will be thawed and injected into the patient over 5 to 10 minutes. The participant will receive the AGAR T CELLS 48 to 72 hours after completing the chemotherapy.
This is a dose escalation study, which means that the investigators do not know the highest dose of GAP T cells that is safe. To find out, the investigators will give the cells to at least 3 participants at one dose level. If that is safe, the investigators will raise the dose given to the next group of participants. The dose each patient gets depends on how many participants get the agent before that patient and how they react. The investigator will tell each patient this information. If your cancer responds to therapy and there are no DLTs, we would allow for up to 3 additional treatments at that same dose. This will help the participant think about possible harms and benefits. Since the treatment is experimental, what is likely to happen at any dose is not known.
All of the treatments will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital.
Medical tests before treatment:
Medical tests during and after treatment:
FOLLOW-UP STUDIES The investigators will follow the participant during and after each injection. To learn more about the way the T cells are working in the participant's body, up to 60 mL (upto 12 teaspoons, no more than 3ml/kg/day) of blood will be taken from the participant before the chemotherapy, before the T-cell infusion, 1 to 4 hours after the infusion, 3 to 4 days after the infusion (this time point is optional ) at 1 week, 2 weeks, 4 weeks and 8 weeks after the injection, every 3 months for
1 year, every 6 months for 4 years and then every year for the next 10 years. Total participation time for this study will be 15 years.
During the time points listed above, if the T cells are found in the participant's blood at a certain amount an extra 5 mL of blood may need to be collected for additional testing.
The investigators will use this blood to look for the frequency and activity of the cells that the investigators have given; that is, to learn more about the way the T cells are working and how long they last in the body. The investigators will also use this blood to see if there are any long-term side effects of putting the new gene (chimeric antigen receptor, CAR) into the cells. In addition to the blood draws, because the participants have received cells that have had a new gene put in them, the participants will need to have long term follow up for 15 years so the investigators can see if there are any long-term side effects of the gene transfer.
Once a year, the participants will be asked to have their blood drawn and answer questions about their general health and medical condition. The investigators may ask the participants to report any recent hospitalizations, new medications, or the development of conditions or illness that were not present when the participants enrolled in the study and may request that physical exams and/or laboratory tests be performed if necessary.
When tumor biopsy is performed for clinical reasons the investigators will request permission to obtain excess sample to learn more about the effects of the treatment on the participant's disease.
In the event of death, the investigators will request permission to perform an autopsy to learn more about the effects of the treatment on the participant's disease and if there were any side effects from the cells with the new gene.
In addition, the investigators would like to ask for participant permission to use tumor biopsy for research purposes only. Associated risk with the biopsy will be discussed with each participant in detail in a procedure specific consent form. The investigators will test the sample to see if the GAP T cells can be found in the tumor and what effect they had on the tumor cells.
If participants develop a second abnormal cancer growth, significant blood or nervous system disorder during the trial, a biopsy sample of the tissue will be tested.
1,345 studies on the registry are indexed under Liver Neoplasms; 335 are open to participants now.
This study's enrollment of 14 is below the median of 48 across 928 interventional studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Procurement Eligibility
Inclusion Criteria:
Exclusion Criteria:
Treatment Eligibility
Inclusion Criteria:
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GPC3-CAR and the IL15 (AGAR T cells) will be administered to patients with GPC3-positive solid tumors.
Genetic: AGAR T cells
Four different dosing schedules will be evaluated. Three to six patients will be evaluated on each dosing schedule. The following dose levels will be evaluated: DL1: 3x10\^7/m2 DL2: 1x10\^8/m2 DL3: 3x10\^8/m2 DL4: 1x10\^9/m2 The doses are calculated according to the actual number of GPC3-CAR transduced T cells.
Also known as: GPC3-CAR T cells
Number of Patients With Dose Limiting Toxicity
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the GPC3-CAR T cells. Specifically those which are Grade 5; non-hematologic Grade 3-4 not returning to Grade 2 within 72 hours; Grade 2-4 allergic reaction; grade 4 hematologic toxicity that persists for 28 days or greater; all grade 4 CRS and neurologic toxicities and grade 3 CRS and neurologic toxicities that fail to return to Grade 1 within 7 days.
Time frame: 4 weeks
Response Rate
Response rate is calculated as the percentage of subjects with the best overall response that is either complete response or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time frame: 4 weeks
Maximum Tolerated Dose (MTD) of Autologous Glypican-3 Specific Chimeric Antigen Expressing T Cells Co-expressing IL-15 Administered to Patients With GPC3-positive Solid Tumors.
Defined as the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate. If there is no DLT that determine a MTD, the maximum dose level will be declared as the MTD. In case the lowest dose level is determined to be too toxic and the elimination boundary is reached, no MTD will be defined for the trial.
Time frame: 28 days
| Milestone | 15.GPC3-CAR T Cells - Dose Level 1 | 15.GPC3-CAR T Cells - Dose Level 2 | 15.GPC3-CAR T Cells - Dose Level 3 |
|---|---|---|---|
| Started | 8 | 0 | 0 |
| Completed | 0 | 0 | 0 |
| Not completed | 8 | 0 | 0 |
| Withdrew: Death | 7 | 0 | 0 |
| Withdrew: On long term follow up | 1 | 0 | 0 |
| Milestone | 15.GPC3-CAR T Cells - Dose Level 1 | 15.GPC3-CAR T Cells - Dose Level 2 | 15.GPC3-CAR T Cells - Dose Level 3 |
|---|---|---|---|
| Started | 0 | 3 | 0 |
| Completed | 0 | 0 | 0 |
| Not completed | 0 | 3 | 0 |
| Withdrew: Death | 0 | 3 | 0 |
| Milestone | 15.GPC3-CAR T Cells - Dose Level 1 | 15.GPC3-CAR T Cells - Dose Level 2 | 15.GPC3-CAR T Cells - Dose Level 3 |
|---|---|---|---|
| Started | 0 | 0 | 3 |
| Completed | 0 | 0 | 0 |
| Not completed | 0 | 0 | 3 |
| Withdrew: Death | 0 | 0 | 2 |
| Withdrew: On long term follow up | 0 | 0 | 1 |
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the GPC3-CAR T cells. Specifically those which are Grade 5; non-hematologic Grade 3-4 not returning to Grade 2 within 72 hours; Grade 2-4 allergic reaction; grade 4 hematologic toxicity that persists for 28 days or greater; all grade 4 CRS and neurologic toxicities and grade 3 CRS and neurologic toxicities that fail to return to Grade 1 within 7 days.
| Participants | 15.GPC3-CAR T Cells - Dose Level 1 | 15.GPC3-CAR T Cells - Dose Level 2 | 15.GPC3-CAR T Cells - Dose Level 3 |
|---|---|---|---|
| Number of Patients With Dose Limiting Toxicity | 1 | 0 | 0 |
Response rate is calculated as the percentage of subjects with the best overall response that is either complete response or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
| Percentage of participants | 15.GPC3-CAR T Cells - Dose Level 1 | 15.GPC3-CAR T Cells - Dose Level 2 | 15.GPC3-CAR T Cells - Dose Level 3 |
|---|---|---|---|
| Response Rate | 50.0 (15.7 to 84.3) | 33.3 (0.8 to 90.6) | 50.0 (1.3 to 98.7) |
Defined as the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate. If there is no DLT that determine a MTD, the maximum dose level will be declared as the MTD. In case the lowest dose level is determined to be too toxic and the elimination boundary is reached, no MTD will be defined for the trial.
| 10^8 cells per square meter | 15.GPC3-CAR T Cells - All Dose Levels (DLT- Evaluable Population) |
|---|---|
| Maximum Tolerated Dose (MTD) of Autologous Glypican-3 Specific Chimeric Antigen Expressing T Cells Co-expressing IL-15 Administered to Patients With GPC3-positive Solid Tumors. | 3.0 |
Collected over Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 15.GPC3-CAR T Cells - Dose Level 1 | 7/8 (87.5%) | 6/8 (75%) | 8/8 (100%) |
| 15.GPC3-CAR T Cells - Dose Level 2 | 3/3 (100%) | 2/3 (66.7%) | 3/3 (100%) |
| 15.GPC3-CAR T Cells - Dose Level 3 | 2/3 (66.7%) | 2/3 (66.7%) | 3/3 (100%) |
| Event | 15.GPC3-CAR T Cells - Dose Level 1 | 15.GPC3-CAR T Cells - Dose Level 2 | 15.GPC3-CAR T Cells - Dose Level 3 |
|---|---|---|---|
| FeverGeneral disorders and administration site conditions | 5/8 | 2/3 | 2/3 |
| Cytokine release syndromeImmune system disorders | 5/8 | 2/3 | 2/3 |
| Ear and labyrinth disorders - Other, specify : phonophobiaEar and labyrinth disorders | 0/8 | 0/3 | 1/3 |
| PhotophobiaEye disorders | 0/8 | 0/3 | 1/3 |
| NauseaGastrointestinal disorders | 0/8 | 0/3 | 1/3 |
| VomitingGastrointestinal disorders | 0/8 | 0/3 | 1/3 |
| FatigueGeneral disorders and administration site conditions | 0/8 | 0/3 | 1/3 |
| Muscle weakness lower limbMusculoskeletal and connective tissue disorders | 0/8 | 0/3 | 1/3 |
| DizzinessNervous system disorders | 0/8 | 0/3 | 1/3 |
| Edema cerebralNervous system disorders | 0/8 | 0/3 | 1/3 |
| Event | 15.GPC3-CAR T Cells - Dose Level 1 | 15.GPC3-CAR T Cells - Dose Level 2 | 15.GPC3-CAR T Cells - Dose Level 3 |
|---|---|---|---|
| NauseaGastrointestinal disorders | 6/8 | 3/3 | 2/3 |
| VomitingGastrointestinal disorders | 4/8 | 3/3 | 1/3 |
| Aspartate aminotransferase increasedInvestigations | 8/8 | 2/3 | 2/3 |
| Lymphocyte count decreasedInvestigations | 8/8 | 3/3 | 3/3 |
| Neutrophil count decreasedInvestigations | 8/8 | 3/3 | 3/3 |
| Platelet count decreasedInvestigations | 7/8 | 3/3 | 2/3 |
| White blood cell decreasedInvestigations | 8/8 | 3/3 | 3/3 |
| HyperglycemiaMetabolism and nutrition disorders | 8/8 | 3/3 | 1/3 |
| HypocalcemiaMetabolism and nutrition disorders | 8/8 | 2/3 | 1/3 |
| HyponatremiaMetabolism and nutrition disorders | 6/8 | 2/3 | 3/3 |
Participants with GPC3-positive solid tumors received 15.GPC3-CAR T cells.
| Age, Continuous(years) | 15.GPC3-CAR T Cells - Dose Level 1 | 15.GPC3-CAR T Cells - Dose Level 2 | 15.GPC3-CAR T Cells - Dose Level 3 | Total |
|---|---|---|---|---|
| Median | 10.5 (6.0 to 20.0) | 4.0 (4.0 to 12.0) | 11.0 (5.0 to 20.0) | 10.5 (4.0 to 20.0) |
| Sex: Female, Male(Participants) | 15.GPC3-CAR T Cells - Dose Level 1 | 15.GPC3-CAR T Cells - Dose Level 2 | 15.GPC3-CAR T Cells - Dose Level 3 | Total |
|---|---|---|---|---|
| Female | 4 | 0 | 2 | 6 |
| Male | 4 | 3 | 1 | 8 |
| Ethnicity (NIH/OMB)(Participants) | 15.GPC3-CAR T Cells - Dose Level 1 | 15.GPC3-CAR T Cells - Dose Level 2 | 15.GPC3-CAR T Cells - Dose Level 3 | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 8 | 3 | 3 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 15.GPC3-CAR T Cells - Dose Level 1 | 15.GPC3-CAR T Cells - Dose Level 2 | 15.GPC3-CAR T Cells - Dose Level 3 | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 1 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 1 |
| White | 6 | 2 | 2 | 10 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.