Study of Donor Derived, Multi-virus-specific, Cytotoxic T-Lymphocytes for Relapsed/Refractory Neuroblastoma

Completed · Phase 1

Conditions studied: Neuroblastoma

In brief

This is a single-center, investigator-initiated, single-arm, pilot study of post-allogeneic transplant, adoptive immunotherapy for the treatment of patients with relapsed/refractory neuroblastoma expressing the mesenchymal tumor marker GD2. Three patients will be treated. The study will focus on the safety and efficacy of allogeneic, donor derived viral specific cytotoxic T-lymphocytes, retrovirally transduced to express a chimeric antigen receptor specific for disialoganglioside, GD2, expressed on neuroblastoma.

Key facts

Study ID

NCT01460901

Run by

Children's Mercy Hospital Kansas City

People needed

5

Starts

2012-10-01

Expected to finish

2015-01-01

Last updated by the study team

2019-07-23

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Allogeneic transduced tV-CTLs with >15% expression of 14g2a.zeta chimeric antigen receptor
• Patient or responsible person must be able to understand and sign a permission/assent or consent form for infusion
• Age 18 months through 17 years at time of relapse/progression
• Life expectancy >8weeks
• Karnofsky score 60% or greater if 10 yrs old or older. Lansky score 60% or greater if under 10 yrs old
• Patient must be HIV negative
• ANC >500
• Pulse ox>90% on room air
• AST/ALT/direct bili <5x upper limit of normal
• Recovered from toxic effects of all prior chemotherapy
• Absence of human/anti-mouse antibody (HAMA) (patients who have received prior therapy with murine antibodies)
• >50% donor engraftment

You may not qualify if…

• Patient pregnant or lactating or refuses birth control methods
• HIV positive
• Uncontrolled intercurrent infection
• Renal failure (creatinine clearance <40ml/min/1.73m2)
• Active hepatitis or cirrhosis with bilirubin, AST, ALT >5xnormal
• Rapidly progressive disease
• Currently receiving any investigational drugs
• Tumor potentially causing airway obstruction
• Cardiomegaly or bilateral pulmonary infiltrates on CXR
• Receiving >0.25mg/kg/day methylprednisolone or equivalent systemic steroid. Topical steroid therapy is acceptable
• Receiving more than one lymphocyte inhibiting agent (ex. Tacrolimus/CSA and MMF or other similar agent
• Patients relapsing or progressing before the age of 18 months from Stage I/II disease, and/or those who, in the opinion of their oncologist, may benefit from further conventional therapy
• Donor lymphocyte infusion in last 28 days
• Evidence of GvHD greater than or equal to grade 2

Where it is running

• Children's Mercy Hospital — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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