Study of CAR T-Cells Targeting the GD2 With IL-15+iCaspase9 for Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT03721068
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • iC9.GD2.CAR.IL-15 T-cells — BIOLOGICAL
    Three dose levels are being evaluated: 0.5 x 10\^6, 1.0 x 10\^6, 1.5 x 10\^6
  • Cyclophosphamide — DRUG
    500 mg/m\^2 IV dose on days 1-2 for lymphodepletion prior to cell infusion
  • Fludarabine — DRUG
    30 mg/m\^2 IV dose on days 1-4 for lymphodepletion prior to cell infusion

Study Details

The body has different ways of fighting infections and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are molecules that fight infections and protect your body from diseases caused by bacteria and toxic substances. Antibodies work by sticking to those bacteria or substances, which stops them from growing and causing bad effects. T cells are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected. Both antibodies and T cells have been used to treat patients with cancers. They both have shown promise, but neither alone has been enough to cure most patients. This multicenter study is designed to combine both T cells and antibodies in order to create a more effective treatment. The treatment that is being researched is called autologous T lymphocyte chimeric antigen receptor cells (CAR) cells targeted against the disialoganglioside (GD2) antigen that express Interleukin (IL)-15, and the inducible caspase 9 safety switch (iC9), also known as iC9.GD2.CAR.IL-15 T cells.

Key Dates

Start date
Feb 19, 2019
Status verified
Mar 2026
Primary completion
May 19, 2030
Completion
Jun 19, 2044

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: iC9.GD2.CAR.IL-15 T-cells
    The continuous reassessment method (CRM) will be used to estimate the maximum-tolerated dose (MTD) of cells that to be given in dose escalation cohorts comprised of 2-6 subjects. The final MTD will be the dose with estimated probability of dose limiting toxicity (DLT) closest to the target toxicity rate of 20%. Three cell doses will be evaluated: 0.5 x 10\^6 cells/kg, 1.0 x 10\^6 cells/kg, 1.5 x 10\^6 cells/kg. Cohort enrollment will be staggered and each subject must complete at least 2 weeks of the cell treatment without incident of DLT before another subject can be enrolled at that dose level. A minimum of two subjects must complete the 4-week post-infusion DLT period before enrollment at the next higher dose level will be considered. If dose level 1 is determined to be above a tolerable dose, de-escalation would occur to dose level -1 where subjects would receive 0.25 x 10\^6 cells/kg.

Primary Outcome Measure

Number of participants with adverse events as a measure of safety and tolerability of iC9.GD2.CAR.IL-15 T cells administered to pediatric subjects with relapsed or refractory neuroblastoma or relapsed/refractory osteosarcoma [ Time Frame: 4 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Emory - Winship Cancer InstituteAtlantaGeorgia30322-
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth Carolina27599-7295
Catherine Cheng
[email protected]
919-445-4208
Caroline Babinec
[email protected]
919-962-7426
George Hucks, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Emory - Winship Cancer Institute· Atlanta, GALineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill· Chapel Hill, NC

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