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CAR T-cell Therapy

CAR T-Cell Therapy for Acute Lymphoblastic Leukemia

Phase 1 & 2

Waitlist Available

Led By Anurag Agrawal, MD

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

Patients must be free from active GVHD and off immunosuppressive GVHD therapy for 4 weeks prior to enrollment

Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is testing a new cancer treatment involving genetically modified cells from the patient's own body. The goal is to find the maximum tolerated dose and to determine efficacy.

Who is the study for?

This trial is for young patients (12 months to less than 27 years old) with CD19+ leukemia that's come back or hasn't responded to treatment. They must weigh at least 10kg, have no severe active infections, and not have had certain prior treatments like genetically modified cell therapy. Those who've had a transplant can join phase 1; others may join phase 2.Check my eligibility

What is being tested?

The study tests CAR T cells made from the patient's own immune cells, engineered to target CD19 on leukemia cells. It aims to find the safest dose and see how well it works. Phase 1 involves post-transplant patients; phase 2 is open more broadly.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal cells by mistake, flu-like symptoms, difficulty breathing, changes in blood pressure and heart rate, fatigue, fever, headache and potential neurological issues.

Eligibility Criteria

Inclusion Criteria

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

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I haven't had active graft-versus-host disease or been on GVHD treatment for 4 weeks.

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

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I haven't taken any corticosteroids, except for replacement doses, in the last week.

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My leukemia has returned after a stem cell transplant.

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I have never had a transplant with donor cells.

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My Non-Hodgkin Lymphoma is not responding to treatment and there are no known cures left for me.

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I am between 12 months and 27 years old.

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I weigh at least 10 kilograms.

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My kidney function tests are normal for my age and gender.

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I do not have any significant brain function issues.

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I can undergo a procedure to collect my blood cells.

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I do not have any active cancer other than CD19+ leukemia.

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I can do most activities but may need help.

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I have not had gene therapy or virus-based treatment that is still in my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Treatment Details

Study Objectives

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

Primary outcome measures

Number of Participants Who Experienced an Adverse Event Meeting the Dose-Limiting Toxicity Definition

Number of Participants Who Have a Releasable Cell Product Generated

Number of Participants With an MRD Negative Complete Remission After Initial CAR T Cell Infusion

Secondary outcome measures

Number of Participants That Received Cetuximab Who Have T Cells Successfully Ablated

Number of Participants With Recrudescence or Development of Acute GVHD (Graft Versus Host Disease) Symptoms Post CAR T Infusion

Persistence of Functional CD19 CAR+ T Cells

Trial Design

7Treatment groups

Experimental Treatment

Group I: Phase 2Experimental Treatment1 Intervention

The phase 2 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 1 x 10^6 CAR T cells/kg following lymphodepletion if indicated.

Group II: Phase 1 - Cohort 1F2Experimental Treatment1 Intervention

This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 1x10^6 CAR T cells/kg following prescribed lymph-depletion with fludarabine and cyclophosphamide

Group III: Phase 1 - Cohort 1F1Experimental Treatment1 Intervention

This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 5x10^5 CAR T cells/kg following prescribed lymph-depletion with fludarabine and cyclophosphamide

Group IV: Phase 1 - Cohort 1DExperimental Treatment1 Intervention

This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 1x10^7 CAR T cells/kg

Group V: Phase 1 - Cohort 1CExperimental Treatment1 Intervention

This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 5x10^6 CAR T cells/kg

Group VI: Phase 1 - Cohort 1BExperimental Treatment1 Intervention

This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 1x10^6 CAR T cells/kg

Group VII: Phase 1 - Cohort 1AExperimental Treatment1 Intervention

This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 5x10^5 CAR T cells/kg

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor

301 Previous Clinical Trials

5,216,810 Total Patients Enrolled

Colleen Annesley, MDStudy ChairSeattle Children's Hospital

3 Previous Clinical Trials

124 Total Patients Enrolled

Rebecca Gardner, MDStudy ChairSeattle Children's Hospital

2 Previous Clinical Trials

84 Total Patients Enrolled

Media Library

Patient Derived CD19 specific CAR T cells also expressing an EGFRt (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02028455 — Phase 1 & 2

Acute Lymphoblastic Leukemia Research Study Groups: Phase 1 - Cohort 1F1, Phase 2, Phase 1 - Cohort 1F2, Phase 1 - Cohort 1C, Phase 1 - Cohort 1A, Phase 1 - Cohort 1B, Phase 1 - Cohort 1D

Acute Lymphoblastic Leukemia Clinical Trial 2023: Patient Derived CD19 specific CAR T cells also expressing an EGFRt Highlights & Side Effects. Trial Name: NCT02028455 — Phase 1 & 2

Patient Derived CD19 specific CAR T cells also expressing an EGFRt (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02028455 — Phase 1 & 2

Frequently Asked Questions

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

Are individuals above the age of twenty eligible to partake in this scientific research?

"To participate in this study, patients must be aged between 1 and 26. Clinicaltrials.gov records 427 trials for those under 18 years old and 1123 studies focus on individuals above the age of 65."

Answered by AI

Are there any openings available for volunteers to join this clinical experiment?

"According to clinicaltrials.gov, this specific medical trial is not presently seeking participants. This study was published on February 11th 2014 and last updated on the 15th of February 2022 - however more than 1400 other trials are currently recruiting individuals."

Answered by AI

Is it possible for me to register in this clinical investigation?

"Eligibility for this trial is limited to persons suffering from leukemia between the ages of one year and twenty-six. A total of 167 participants are being accepted into the study."

Answered by AI

Recent research and studies

Journal of Clinical InvestigationJournal

CD19 CAR T Cell Product and Disease Attributes Predict Leukemia Remission Durability

Finney, Olivia C., Hannah Brakke, Stephanie Rawlings-Rhea, Roxana Hicks, Danielle Doolittle, Marisa Lopez, Ben Futrell, et al.. 2019. “CD19 CAR T Cell Product and Disease Attributes Predict Leukemia Remission Durability”. Journal of Clinical Investigation. American Society for Clinical Investigation. doi:10.1172/jci125423.

BloodJournal

Intent-to-treat Leukemia Remission by CD19 CAR T Cells of Defined Formulation and Dose in Children and Young Adults

Gardner, Rebecca A., Olivia Finney, Colleen Annesley, Hannah Brakke, Corinne Summers, Kasey Leger, Marie Bleakley, et al.. 2017. “Intent-to-treat Leukemia Remission by CD19 CAR T Cells of Defined Formulation and Dose in Children and Young Adults”. Blood. American Society of Hematology. doi:10.1182/blood-2017-02-769208.

BloodJournal

Acquisition of a Cd19-negative Myeloid Phenotype Allows Immune Escape of Mll-rearranged B-ALL from CD19 Car-t-cell Therapy

Gardner, Rebecca, David Wu, Sindhu Cherian, Min Fang, Laïla-Aïcha Hanafi, Olivia Finney, Hannah Smithers, et al.. 2016. “Acquisition of a Cd19-negative Myeloid Phenotype Allows Immune Escape of Mll-rearranged B-ALL from CD19 Car-t-cell Therapy”. Blood. American Society of Hematology. doi:10.1182/blood-2015-08-665547.

Transplantation and Cellular TherapyJournal