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CAR T-cell Therapy

CAR T-cell Therapy for Neuroblastoma

Phase 1

Waitlist Available

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

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

Must have

Measurable or evaluable disease

Prior diagnosis of NB or ganglioneuroblastoma either by histologic verification and/or demonstration of tumor cells in the bone marrow with increased catecholamine levels

Must not have

Presence of a primary immunodeficiency/bone marrow failure syndrome

Presence of active severe infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for neuroblastoma that involves genetically modifying the patient's own T cells to make them better at attacking the cancer.

Who is the study for?

This trial is for children and young adults up to 26 years old with high-risk neuroblastoma or ganglioneuroblastoma that's resistant to standard treatments. They must have a life expectancy of at least 8 weeks, be in relatively stable health, and not have received certain recent therapies like allogeneic stem cell transplants.

What is being tested?

The ENCIT-01 study tests different versions of genetically engineered T cells designed to target CD171 on neuroblastoma cells. It aims to find the highest dose patients can tolerate without severe side effects. These T cells are taken from the patient, modified in the lab, then given back to attack the cancer.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever, fatigue, and flu-like symptoms; possible damage to normal tissues expressing CD171; and typical risks associated with infusion of cellular products.

Eligibility Criteria

Inclusion Criteria

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

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My cancer can be measured or seen on tests.

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I was diagnosed with neuroblastoma or ganglioneuroblastoma, confirmed by tests.

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It has been over 30 days or 3 half-lives since my last antibody therapy.

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I have not had gene-modified cell therapy, or it's no longer detectable.

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I am not currently undergoing external radiation and it's been over 12 weeks since my last I131 MIBG therapy.

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I can do most activities but need help with some.

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I am 26 years old or younger.

Exclusion Criteria

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

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I have a condition that affects my immune system or bone marrow.

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I am currently suffering from a severe infection.

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I have a history of or currently have significant brain-related health issues.

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I cannot undergo apheresis or have a catheter placed for it.

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I have an active cancer that is not neuroblastoma.

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I am not currently receiving any cancer treatments or radiotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~42 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose Limiting Toxicity

Secondary study objectives

Response (Tumor response will be evaluated by the revised International Neuroblastoma Response Criteria)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: C: Long Spacer 2nd Generation CE7R CAR T CellsExperimental Treatment1 Intervention

Autologous CD4 and CD8 cells are lentivirally transduced to generate patient-derived CD171 specific CAR T cells also expressing an EGFRt. Patients will receive lymphodepletion chemotherapy prior to T cell infusion. CD171 specific CAR T cells will be administered approximately 2-3 days after lymphodepletion chemotherapy. Cells will be administered approximately 1:1 CD4 and CD8 cells with planned dose level evaluations of total T cell dose of 1x10\^6 cells/kg, 5x10\^6 cells/kg, 1x10\^7 cells/kg, 5x10\^7 cells/kg, and 1x10\^8 cells/kg will be evaluated.

Group II: B: 3rd Generation CE7R CAR T CellsExperimental Treatment1 Intervention

Group III: A: 2nd Generation CE7R CAR T CellsExperimental Treatment1 Intervention

0 / 13Eligibility criteria met