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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

Must not have

Patients must NOT have an active severe infection defined as a positive blood culture within 48 hours of study enrollment or a fever above 38.2 C AND clinical signs of infection within 48 hours of study enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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

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

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

Primary study objectives

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 study objectives

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

Persistence of Functional 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

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 / 15Eligibility criteria met