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New treatment option for Solid Tumor (Excluding CNS)
Official title Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells
ClinicalTrials.gov ID: NCT07148050
What this study is testing
What is SC-CAR.GPC3xIL15.21 CAR T cells?
SC-CAR.GPC3xIL15.21 CAR T cells is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for solid tumor (excluding cns).
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
- This Phase 1, open-label, non-randomized study will enroll pediatric and young adult subjects with relapsed or refractory non-central nervous system (CNS) malignant solid tumors expressing glypican-3 (GPC3) to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to co-express a GPC3-specific chimeric antigen receptor (CAR), interleukin (IL)-15 and IL-21 as well as the inducible caspase 9 (iC9) suicide gene (SC-CAR.GPC3xIL15.21 T cells). A child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have a blood sample collected, which will be used to bioengineer the CAR T cells targeting their tumor.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 26
You may be able to join if
- Procurement Eligibility
- Diagnosis of a solid tumor expressing GPC3
- Lansky or Karnofsky score of \>=60%
- Life expectancy of \>16 weeks
- Informed consent explained to, understood by and signed by patient/guardian. For patients with hepatocellular carcinoma only:
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 for...
- 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:
- Lansky or Karnofsky score of \>=60%
See the full eligibility criteria
- Procurement Eligibility
- Diagnosis of a solid tumor expressing GPC3
- Lansky or Karnofsky score of \>=60%
- Life expectancy of \>16 weeks
- Informed consent explained to, understood by and signed by patient/guardian. For patients with hepatocellular carcinoma only:
- Barcelona Liver Cancer Stage A, B or C
- Child-Pugh Turcotte Score \<7
- History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for 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:
- Lansky or Karnofsky score of \>=60%
- Life expectancy of \>16 weeks
- Informed consent explained to, understood by and signed by patient/guardian.
- Adequate organ function
- Adequate laboratory values
- 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 12 months after the T-cell infusion.
- Informed consent explained to, understood by and signed by patient/guardian. For patients with hepatocellular carcinoma only:
- Barcelona Liver Cancer Stage A, B or C
- Child-Pugh Turcotte Score \<7 Exclusion Criteria:
- History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.
- History of organ transplantation
- Known HIV positivity
- Active autoimmune or inflammatory disorder
- Live vaccines within 30 days prior to enrollment
- Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)
- Pregnancy or lactation
- Uncontrolled infection
- Systemic steroid treatment (≥ 0.5 mg prednisone equivalent/kg/day, dose adjustment or discontinuation of medication must occur at least 24hrs prior to CAR T cell infusion)
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, 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, 1 year to 26 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, 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.