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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Limiting Toxicity

Secondary outcome measures

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

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor

301 Previous Clinical Trials

5,216,912 Total Patients Enrolled

4 Trials studying Neuroblastoma

630 Patients Enrolled for Neuroblastoma

Ben Towne Center for Childhood Cancer ResearchOTHER

The Evan FoundationOTHER

4 Previous Clinical Trials

173 Total Patients Enrolled

4 Trials studying Neuroblastoma

173 Patients Enrolled for Neuroblastoma

Media Library

Patient Derived CD171 specific CAR T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02311621 — Phase 1

Neuroblastoma Research Study Groups: C: Long Spacer 2nd Generation CE7R CAR T Cells, B: 3rd Generation CE7R CAR T Cells, A: 2nd Generation CE7R CAR T Cells

Neuroblastoma Clinical Trial 2023: Patient Derived CD171 specific CAR T cells Highlights & Side Effects. Trial Name: NCT02311621 — Phase 1

Patient Derived CD171 specific CAR T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02311621 — Phase 1

Frequently Asked Questions

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

Has the FDA sanctioned usage of CD171-specific CAR T cells expressing EGFRt (third generation T cells) derived from patients?

"Our in-house team at Power assigned a 1 to the safety of Patient Derived CD171 specific CAR T cells expressing EGFRt (3rd generation T cells) due to its Phase I status, implying that both efficacy and safety are still being preliminarily evaluated."

Answered by AI

Does the research team accept subjects younger than twenty years old?

"This research requires that interested participants fall between 18 Months to 26 years old. There are 159 studies for minors and 42 trials available for elderly individuals above the age of 65."

Answered by AI

Is this medical trial currently in the process of gathering participants?

"Clinicaltrials.gov reveals that this study, initially posted on November 25th 2014 and last updated May 2nd 2022, is not taking new patients at present. Despite this fact, there are still 161 other clinical trials in need of volunteers right now."

Answered by AI

Is there an opportunity for me to take part in this medical trial?

"This clinical trial seeks 65 individuals aged 18 months to 26 years with a diagnosis of neuroblastoma. Additionally, applicants must have had evidence of metastatic progression when they were over the age of 18 months and possess an expected life expectancy greater than 8 weeks. Furthermore, no systemic corticosteroids should be taken within 7 days prior to enrollment except in cases where physiologic replacement dosing is needed; however, topical administration (e.g: inhaled or dermatologic) is permissible. Participants are also required to not take anti-tumor directed antibody therapy for at least 3 half-lives or 30 days before enrolling in"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Engineered Neuroblastoma Cellular Immunotherapy (ENCIT)-01

Colleen Annesley 2014. "Engineered Neuroblastoma Cellular Immunotherapy (ENCIT)-01". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02311621.

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