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Monoclonal Antibodies

Immunotherapy for Neuroblastoma

Phase 1

Waitlist Available

Research Sponsored by New Approaches to Neuroblastoma Therapy Consortium

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All patients must have at least one of the following: Recurrent/progressive disease, Refractory disease, Persistent disease

Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study registration

Must not have

Active or uncontrolled infection

Patient declines participation in NANT 2004-05

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 1 of protocol therapy through 30 days following end of protocol therapy

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will determine how well autologous expanded natural killer cells work with standard dosing of dinutuximab and with or without lenalidomide in treating children with neuroblastoma that has come back or does not respond to treatment.

Who is the study for?

This trial is for children with neuroblastoma that hasn't responded to initial treatments or has come back. They must have a certain type of tumor activity visible on specific scans, be under 30 years old, and have an expected lifespan of at least 12 weeks. Their heart, kidney, liver, and blood functions need to meet set levels. Pregnant or breastfeeding individuals can't join.

What is being tested?

The study tests the highest dose kids can handle of NK cells (a type of immune cell) combined with dinutuximab (an antibody therapy). It also looks at adding lenalidomide (a cancer drug) to this mix for those who've had no luck with standard treatments for their aggressive neuroblastoma.

What are the potential side effects?

Possible side effects include reactions related to the immune system like fever and chills from dinutuximab infusion; low blood counts leading to increased infection risk; tiredness; and skin rashes or other allergic reactions especially when starting lenalidomide.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My disease is either coming back, not responding, or has never fully gone away.

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I have recovered from side effects of my previous cancer treatments.

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I am not taking any other cancer treatments or undergoing radiotherapy while on this trial.

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I have been diagnosed with neuroblastoma confirmed by tests.

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My cancer shows up on specific scans and has been confirmed with a biopsy.

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I am expected to live at least 12 weeks and can do some daily activities on my own.

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I am 30 years old or younger.

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I have a measurable cancer lesion.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any ongoing or uncontrolled infections.

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I have chosen not to participate in the NANT 2004-05 study.

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My cancer has spread to my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 of protocol therapy through 30 days following end of protocol therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 of protocol therapy through 30 days following end of protocol therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 of protocol therapy through 30 days following end of protocol therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MTD/RP2D determination

NK cell production feasibility

NK cell production feasibility (lowest dose level)

Secondary study objectives

Describe Hematological Toxicities

Describe Non-Hematological Toxicities

Overall Response

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NK cells with Dinutuximab & LenalidomideExperimental Treatment3 Interventions

Patients in this arm will receive a designated dose of NK cells on Day 5 and 17.5 mg/m2/dose of dinutuximab on Day 1-4. Patients on Dose Level 4 will also receive 25mg/m2/dose of Lenalidomide during Day -6 through 14 of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NK Cells

2020

Completed Phase 2

~40

Dinutuximab

FDA approved

Lenalidomide

2005