Recruiting
Phase 1
Phase 2

GD2 Bispecific Antibody

Sponsor:

University of Virginia

Code:

NCT02173093

Conditions

Disseminated Neuroblastoma

Recurrent Neuroblastoma

Eligibility Criteria

Sex: All

Age: 1 - 29

Healthy Volunteers: Not accepted

Interventions

IL-2

GD2Bi-aATC

GM-CSF

laboratory evaluations of immune responses

Study Details

Brief summary:

Previous research has demonstrated that investigators can coat (arm) T cells with a special molecule called GD2 bispecific antibody that will help T cells recognize neuroblastoma and osteosarcoma cells and kill them. This bispecific antibody recognizes GD2, a protein found on almost all neuroblastoma and osteosarcoma cells. The investigators put the GD2 bispecific antibody on T cells and give large numbers of these T cells back to patients. The investigators think that these T cells may have a better chance of killing GD2 expressing tumor cells when they are armed with GD2 bispecific antibody. This trial studies the side effects and best dose of activated T cells armed with GD2 bispecific antibody and how well they work in treating patients with neuroblastoma, osteosarcoma, and other GD2-positive solid tumors.

Conditions

Disseminated Neuroblastoma

Recurrent Neuroblastoma

Study ID

NCT02173093

Start date

Nov, 2014

Status verified date

Jan, 2019

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 29

Healthy Volunteers: Not accepted

The study is now in the phase II expansion phase.

Inclusion Criteria for phase II:

  • The target tumor is limited to neuroblastoma and the diagnosis should be histologically verified.
  • Patients must have refractory or recurrent malignancy; patient's current disease state must be one for which no known curative therapy is available;
  • Patients should not receive any other experimental or phase 1 therapy within 3 weeks prior to study enrollment and monoclonal antibody therapy within 6 weeks
  • To be eligible for phase I study patients should have primary refractory or relapsed disease as evidenced by:

  • Local tumor recurrence measurable on CT or magnetic resonance imaging (MRI) scans with or without metastatic lesions
  • Refractory bone marrow involvement in patients with NB
  • NB with MIBG-positive skeletal lesions
  • The presence of radiographically measurable disease immediately prior to start of Phase I immunotherapy is not an eligibility requirement in the following situations:

  • In patients with NB who have documented bone marrow (BM) involvement;
  • In patients with NB who have MIBG-positive bony lesion(s);
  • An additional eligibility requirement for phase II study includes the presence of radiographically measurable disease with the exception of MIBG-positive NB or NB with bone marrow involvement:
  • Patients must have a Lansky or Karnofsky performance status score of >= 70
  • Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy

  • Myelosuppressive chemotherapy: must not have received within 3 weeks of starting immunotherapy (IT)
  • Hematopoietic growth factors: at least 7 days since the last dose of growth factor therapy
  • Immunotherapy: at least 6 weeks must have elapsed since prior therapy that includes a monoclonal antibody
  • Normal organ function
  • All patients or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

  • Patients who are pregnant or breast-feeding are not eligible for this study; negative pregnancy tests must be obtained in girls who are postmenarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study therapy and for 3 months after the last dose of GD2Bi-aATC; breastfeeding women should be excluded
  • Patients who have an uncontrolled infection are not eligible
  • Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (IL-2, GM-CSF, GD2Bi-aATC)

Patients receive IL-2 SC daily on days -2 to 35, GM-CSF SC twice weekly x 5 weeks, and GD2Bi-aATC IV over 30 minutes twice weekly x 4 weeks for a total of 8 infusions. Laboratory evaluations of immune responses are obtained prior and after immunotherapy.

Interventions

IL-2

Given SC

GD2Bi-aATC

Given IV

GM-CSF

Given SC

laboratory evaluations of immune responses

Correlative studies

Primary outcome measure

  • Maximum tolerated dose (MTD) of GD2Bi-aATC [ Time Frame: 35 days ]

Central Contacts and Locations

Central contacts

Holly Davis

haw5d@virginia.edu

Locations

Children's Hospital of Michigan

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Maxim Y. Yankelevich, MD

313-745-5516myankele@med.wayne.edu

Diana Gomez, MPH

313-745-7163

Principal Investigator:

Maxim Y. Yankelevich, MD

Memorial Sloan-Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Shakeel Modak, M.D.

modaks@mskcc.org

Principal Investigator:

Shakeel Modak, M.D.

University of Virginia, Department of Pediatrics, Hematology/Oncology

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Daniel (Trey) Lee, MD

434-297-4289DWL4Q@Virginia.edu

Principal Investigator:

Daniel (Trey) Lee, MD

More Information

Sponsor

University of Virginia

Last update posted

Jan 29, 2019

Last verified

Jan, 2019

Keywords

  • Neuroblastoma
  • Solid tumor
  • Immunotherapy targeting GD2
  • Bispecific antibodies
  • Activated T cells

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Virginia on 2019-01-29.