← Back to Search

CAR T-cell Therapy

CAR T-Cell Therapy for Neuroblastoma and Osteosarcoma

Phase 1
Recruiting
Led By George Hucks, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate performance status as defined by Lansky or Karnofsky performance status of ≥ 60 (Lansky for <16 years of age)
First or greater relapse of neuroblastoma following completion of aggressive multi-drug frontline therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that combines two existing 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. T cells are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected. The new treatment 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

Who is the study for?
This trial is for people with specific cancers: relapsed/refractory neuroblastoma or osteosarcoma. Participants need a life expectancy of at least 12 weeks, have had previous aggressive treatment, and must not be pregnant or breastfeeding. They should not have hypersensitivity to the drugs used in the study or any other active malignancy requiring treatment.Check my eligibility
What is being tested?
The trial tests a new therapy combining T cells (immune cells) and antibodies targeting GD2, a cancer cell marker, enhanced with IL-15 to boost effectiveness and an iCaspase9 safety switch. It's given after pre-treatment with Cyclophosphamide and Fludarabine to prepare the body.See study design
What are the potential side effects?
Potential side effects include reactions related to immune response such as fever, fatigue, allergic reactions due to murine proteins in the CAR T-cells, and possible complications from preconditioning drugs like nausea or low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can do most activities but may need help.
Select...
My neuroblastoma has returned after completing initial intense treatment.
Select...
My neuroblastoma worsened for the first time during initial intense treatment.
Select...
I do not have any known brain or spinal cord diseases.
Select...
My initial diagnosis was confirmed as neuroblastoma or ganglioneuroblastoma.
Select...
My brain functions are within normal ranges.
Select...
I have high-risk neuroblastoma or osteosarcoma that's not responding to treatment.
Select...
I do not need medication for seizures.
Select...
My cancer's growth can be tracked with specific medical criteria.
Select...
My neuroblastoma is high-risk and has not responded to treatment or has come back.
Select...
My neuroblastoma hasn't fully responded after 4+ cycles of intense chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neuroblastoma
Secondary outcome measures
Anti-tumor response rate to iC9.GD2.CAR.IL-15 t cell administration in pediatric subjects with relapsed or refractory neuroblastoma per Revised International Neuroblastoma Response Criteria (INCR) or relapsed/refractory osteosarcoma by RECIST v1.1
Expansion and persistence of iC9.GD2.CAR.IL-15 cells in vivo
Identify the maximum tolerated dose (MTD) of iC9.GD2.CAR.IL-15 T cells administered to pediatric subjects with relapsed or refractory neuroblastoma or relapsed/refractory osteosarcoma
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: iC9.GD2.CAR.IL-15 T-cellsExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

Bellicum PharmaceuticalsIndustry Sponsor
26 Previous Clinical Trials
1,292 Total Patients Enrolled
University Cancer Research Fund at Lineberger Comprehensive Cancer CenterUNKNOWN
3 Previous Clinical Trials
110 Total Patients Enrolled
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
348 Previous Clinical Trials
88,153 Total Patients Enrolled
1 Trials studying Neuroblastoma
7 Patients Enrolled for Neuroblastoma

Media Library

iC9.GD2.CAR.IL-15 T-cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03721068 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant count of this research endeavor?

"Affirmative. Clinicaltrials.gov's records affirm that this trial is still actively recruiting participants, having been initially uploaded on the 19th of February 2019 and most recently updated on 22nd September 2022. This research requires 18 people to fill two spots at different sites."

Answered by AI

Could I be a candidate for this research trial?

"Currently, this clinical trial is seeking 18 participants between the ages of 18 months and 18 suffering from osteosarcoma. Eligibility requires that enrollees have a Lansky or Karnofsky performance score of 60 or above; possess written HIPAA authorization signed by legal guardian; life expectancy exceeding 12 weeks; histological confirmation of initial diagnosis for either neuroblastoma, ganglioneuroblastoma, first relapse post-multidrug frontline treatment, progressive disease during said therapy , persistent/refractory condition as defined by Revised INRC criteria after at least 4 cycles of induction chemo on an applicable high risk protocol (e"

Answered by AI

What potential hazards are associated with iC9.GD2.CAR.IL-15 T-cells?

"Evidence of safety and efficacy regarding iC9.GD2.CAR.IL-15 T-cells is scant, thus our team at Power rated it a 1 on the scale from 1 to 3"

Answered by AI

Are participants who are younger than 45 years of age accepted for this research trial?

"This experiment has a narrow age range of 18 Months to 18 years. There are 537 studies available for minors and 751 for seniors aged 65 or higher."

Answered by AI

Does this study currently accept volunteers?

"Confirmatively, this clinical trial is still in search of participants. According to the repository on clinicaltrials.gov, its inception happened on February 19th 2019 and underwent a revision as recently as September 22nd 2022."

Answered by AI

For what purposes is iC9.GD2.CAR.IL-15 T-cell treatment commonly prescribed?

"iC9.GD2.CAR.IL-15 T-cells are most frequently used for the treatment of multiple sclerosis, though they have also been applied to mixed-cell type lymphoma, leukemia, myelocytic acute and retinoblastoma cases with some success."

Answered by AI

Has there been prior research done concerning iC9.GD2.CAR.IL-15 T-cells?

"The iC9.GD2.CAR.IL-15 T-cells have been studied since 1997 at City of Hope Comprehensive Cancer Center, resulting in 1275 finished studies to date and 889 still ongoing tests; many taking place in Chapel Hill, North carolina."

Answered by AI
~1 spots leftby Jun 2024