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CAR T-cell Therapy

CAR T-Cell Therapy for Acute Lymphoblastic Leukemia

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

Absolute lymphocyte count of >/=750 cell/mm3 or >/=500 is >20kg

CD19+ Leukemia in 1st marrow relapse with MRD at the end of 1st month of re-induction

Must not have

Systemic corticosteroids within 7 days of enrollment

Primary immunodeficiency/bone marrow failure syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new leukemia treatment where the patient's own T cells are modified to kill leukemia cells.

Who is the study for?

This trial is for children and young adults aged 1-26 with CD19+ Leukemia that's relapsed multiple times. Participants must have a certain level of physical fitness, adequate organ function, no severe infections or other health conditions that could interfere with the treatment, and not be pregnant. They should also agree to long-term follow-up.

What is being tested?

The study tests genetically modified T cells designed to attack leukemia by recognizing a protein called CD19 on cancer cells. It aims to find the highest safe dose of these CAR+ T cells and assess their toxicity as well as effectiveness in treating leukemia.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever, fatigue, difficulty breathing, changes in blood pressure or heart rate; there might also be risks associated with cell therapy like anemia or infection due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

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

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My lymphocyte count is high enough for the trial.

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My leukemia has returned and shows specific markers after initial treatment.

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My leukemia has returned at least twice and tests positive for CD19.

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I have CD19+ leukemia and need a stem cell transplant but cannot have one.

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I am between 1 and 26 years old.

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I am able to live my life with some help or independently.

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

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

Exclusion Criteria

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

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I haven't taken any corticosteroids in the last week.

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I have a primary immunodeficiency or bone marrow failure.

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I do not have any major brain-related health issues.

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I am not pregnant or breastfeeding and agree to use contraception for 1 year after treatment.

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I have Down syndrome.

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I have had a stem cell transplant from a donor.

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I need extra oxygen or have an infection in my lungs.

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My leukemia is Philadelphia chromosome positive.

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My brain function is moderately or severely impaired.

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I have a cancer diagnosis other than CD19+ leukemia.

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I do not have a severe infection or fever higher than 38.2C recently.

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I have had CAR T-cell therapy before.

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

Number of Participant with Adverse Events

Secondary study objectives

Determine if there is anti-leukemic activity of the CD19 CAR+ T cells

Persistence of the CD19 CAR+ T cells

Awards & Highlights

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: CAR+ T cellsExperimental Treatment1 Intervention

Subjects will receive two days of cyclophosphamide for a total of 3g/m\^2 followed several days later by a single dose of Autologous CD19 CAR+ EGFTt + T cells

0 / 20Eligibility criteria met