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New treatment option for Hepatoblastoma
Official title Immunotherapy For Adults With GPC3-Positive Solid Tumors Using IL-15 and IL-21 Armored GPC3-CAR T Cells
ClinicalTrials.gov ID: NCT06198296
What this study is testing
What is 21.15.GPC3-CAR T cells?
21.15.GPC3-CAR T cells is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for hepatoblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 21
You may be able to join if
- Procurement
- Diagnosis of GPC3-positive\ solid tumors (as determined by immunohistochemistry with an extent score of \>=Grade 2 [\>25% positive tumor cells] and...
- Age ≥21 years
- Lansky or Karnofsky score ≥60%
- Life expectancy ≥16 weeks
You likely can't join if
- History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only...
- History of organ transplantation
- Known HIV positivity
- Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections) Treatment Inclusion Criteria:
- Diagnosis of GPC3-positive solid tumor
- Age ≥ 21 years
See the full eligibility criteria
- Procurement
- 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 ≥21 years
- Lansky or Karnofsky score ≥60%
- Life expectancy ≥16 weeks
- Barcelona Clinic Liver Cancer Stage A, B or C (- 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 \ GPC3 expression will be evaluated by standard immunohistochemistry (IHC) at Texas Patients's...
- 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 Inclusion Criteria:
- Diagnosis of GPC3-positive solid tumor
- Age ≥ 21 years
- Barcelona Clinic Liver Cancer Stage A, B or C
- Life expectancy of ≥ 12 weeks
- Lansky or Karnofsky score ≥ 60%
- Child-Pugh-Turcotte score \< 7
- 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 \> 500/µl
- platelet count \> 25,000/µl (can be transfused)
- Hgb ≥ 7.0 g/dl (can be transfused)
- 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, as determined by history and physical exam
- 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 Treatment 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 24hrs 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)
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.