Supercharged immune cells take on childhood cancers
NCT ID NCT04715191
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This early-phase trial tests a new immunotherapy called CARE T cells in children and young adults with solid tumors that have returned or not responded to standard treatment. The cells are taken from the patient, genetically modified to recognize a protein (GPC3) found on many solid tumors, and given extra signals (IL15 and IL21) to help them survive and fight longer. The main goals are to find a safe dose and 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
- CARE T cells (genetically modified immune cells with GPC3-CAR, IL15, and IL21)
- What this could lead to
- If it works, this could point toward a new treatment option for children with hard-to-treat solid tumors like liver cancer or rhabdomyosarcoma.
- What could go wrong
- This is a very early (Phase 1) trial with only 24 participants, so it is too soon to know if the cells are effective. There are also risks of serious side effects, including cytokine release syndrome and 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
-
About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2024
- Expected to finish
-
Jul 2042
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 * Lansky or Karnofsky score ≥60% * Life expectancy ≥16 weeks * 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) 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 * Total bilirubin \< 3 times ULN for age * INR ≤1.7 (for patients with hepatocellular carcinoma only) * Absolute neutrophil count \> 750/µl * Platelet count \> 75,000/µl (Needs to be confirmed prior to treatment whether with or without transfusion) * Hgb ≥ 8.0 g/dl (Needs to be confirmed prior to treatment whether with or without transfusion) * Pulse oximetry ≥ 92% on room air * Incurable disease after treatment with up- front therapy (Patients who have relapsed disease despite a standard of care salvage therapy) * Wash out period, such that patient has recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study, and returned to their clinical baseline, as determined by history and physical exam. * Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 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 \[except Hepatitis B (HBV patients with active disease who meet the criteria for anti-HBV therapy should be on a suppressive antiviral therapy prior to initiation of cancer therapy) or Hepatitis C virus infections (should have completed curative antiviral treatment with HCV viral load below the limit of quantification\] * Congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis * Active autoimmune or inflammatory disorder * Live vaccines within 30 days prior to enrollment * 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)
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Texas Children's Hospital
RECRUITINGHouston, 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?