Supercharged t cells take on childhood cancers
NCT ID NCT04377932
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a new immunotherapy called AGAR T cells in children with solid tumors such as liver cancer, Wilms tumor, and rhabdomyosarcoma that have returned or not responded to standard care. The cells are made from the patient's own T cells, which are genetically modified to recognize a protein (GPC3) found on many solid tumors and to produce IL15, a protein that helps them survive longer. The main goals are to find a safe dose and to see if the cells can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AGAR T cells (genetically engineered immune cells with GPC3-CAR and IL15)
- What this could lead to
- If it works, this could point toward a new treatment option for children with hard-to-treat solid tumors that have come back or not responded to standard therapy.
- What could go wrong
- This is a very early (Phase 1) and small trial (14 participants), so it is mainly checking safety and dosing. The treatment may not shrink tumors, and there are risks of serious side effects like cytokine release syndrome or nerve problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
14 people
The number who actually took part.
- Started
-
Aug 2021
- Expected to finish
-
Aug 2040
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
1 year to 21 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Procurement Eligibility Inclusion Criteria: * Diagnosis of GPC3-positive\* solid tumors (as determined by immunohistochemistry with an extent score of \>=Grade 2 \[\>25% positive tumor cells\] and an intensity score of \>= 2 \[scale 0-4\]). * Age ≥ 1 year and ≤ 21 years * Life expectancy of ≥ 16 weeks * Lansky or Karnofsky score ≥60% * Barcelona Clinic Liver Cancer Stage A, B or C (for patients with hepatocellular carcinoma only * Child-Pugh-Turcotte score \<7 (for patients with hepatocellular carcinoma only) * Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent Exclusion Criteria: * History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies) * History of organ transplantation * Known HIV positivity * Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections) * Actively progressing CNS metastases Treatment Eligibility Inclusion Criteria: * Age ≥ 1 year and ≤ 21 years * Barcelona Clinic Liver Cancer Stage A, B or C (for patients with hepatocellular carcinoma only) * Lansky or Karnofsky score ≥ 60% * Child-Pugh-Turcotte score \< 7 (for patients with hepatocellular carcinoma only) * Adequate organ function: * Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml/min * serum AST\< 5 times ULN * total bilirubin \< 3 times ULN for age * INR ≤1.7 (for patients with hepatocellular carcinoma only) * absolute neutrophil count \> 500/microliter * platelet count \> 25,000/microliter (can be transfused but must be at that level prior to treatment) * Hgb ≥7.0 g/dl (can be transfused but must be at that level prior to treatment) * pulse oximetry \>90% on room air * Refractory or relapsed disease after treatment with up- front therapy and at least one salvage treatment cycle * Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study * Sexually active patients must be willing to utilize one of the more effective birth control methods for 3 months after the T-cell infusion. * Informed consent explained to, understood by and signed by patient/ guardian. Patient/guardian given copy of informed consent Exclusion Criteria * Pregnancy or lactation * Uncontrolled infection * Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day, dose adjustment or discontinuation of medication must occur at least 24 hours prior to CAR T cell infusion) * Known HIV positivity * Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections) * History of organ transplantation * History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies) * Actively progressing CNS metastases
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Liposarcoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Texas Children's Hospital
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- AI-Enhanced ultrasound aims to catch liver cancer earlier
- A pill that blocks RAS: can it help children whose tumors came back?
- Can acupuncture soothe Chemotherapy's lingering nerve pain?
- Burning away bile duct blockages: a new weapon against cholangiocarcinoma?
- A single blood draw to detect five cancers before symptoms appear?
- Can immune cell infusions help fight solid tumors?