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CAR T-cell Therapy

Dual-Targeted CAR-T Therapy for 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
First 2 subjects: male and female subjects age ≥18 and < 27 years (as of 2/16/18 the first 2 subjects were enrolled and treated); subsequent subjects <31 years
Diagnosis of CD19+22+ leukemia
Must not have
Presence of active clinically significant CNS dysfunction
Unable to tolerate apheresis procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to treat leukemia by using genetically modified T-cells.

Who is the study for?
This trial is for patients under 31 years old with CD19+CD22+ leukemia that's resistant to standard treatments. They must have a life expectancy of at least 8 weeks, be free from severe infections or CNS dysfunction, not pregnant or breastfeeding, and able to tolerate cell collection procedures. Participants should also meet certain health and laboratory criteria.
What is being tested?
The study tests a new therapy using the patient's own T-cells genetically modified to target two proteins on leukemia cells (CD19 and CD22). It aims to see if this dual-targeting approach is safe and feasible in producing enough modified T-cells for treatment.
What are the potential side effects?
Potential side effects may include immune reactions due to CAR-T cells targeting normal tissues expressing CD19/CD22, flu-like symptoms, fatigue, fever, difficulty breathing, changes in blood pressure or heart rate. The severity can vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am under 31 years old.
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My leukemia tests positive for both CD19 and CD22.
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My leukemia has returned after a stem cell transplant and tests positive for CD19 and CD22.
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I haven't had active graft-versus-host disease and have been off related treatments for 4 weeks.
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I can do most activities but need help with some.
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It has been over a week since my last chemotherapy session.
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I have not had gene therapy or virus-based treatment that's 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 have significant brain or nerve problems affecting my daily life.
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I cannot undergo apheresis due to health reasons.
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I have an active cancer that is not CD19+CD22+ leukemia.
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I am currently suffering from a severe infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 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
The adverse events associated with one or multiple CAR T-cell product infusions will be assessed
The number of successfully and unsuccessfully manufactured and infused CAR T-cell products will be assessed

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Patient-derived CD19- and CD22 specific CAR v2Experimental Treatment1 Intervention
Patient-derived CD19-specific CAR also expressing an HER2t and CD22-specific CAR T-cells also expressing an EGFRt
Group II: Patient-derived CD19- and CD22 specific CAR v1Experimental Treatment1 Intervention
Patient-derived CD19-specific CAR also expressing an HER2t and CD22-specific CAR T-cells also expressing an EGFRt

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor
310 Previous Clinical Trials
5,231,502 Total Patients Enrolled
12 Trials studying Leukemia
1,174 Patients Enrolled for Leukemia
Colleen Annesley, MDStudy ChairSeattle Children's Hospital
5 Previous Clinical Trials
231 Total Patients Enrolled
4 Trials studying Leukemia
219 Patients Enrolled for Leukemia
Rebecca Gardner, MDStudy Chair - Seattle Children's Hospital
Seattle Cancer Care Alliance, Seattle Children's Hospital
University Of Maryland School Of Medicine (Medical School)
University Of Wa School Of Medicine (Residency)
2 Previous Clinical Trials
173 Total Patients Enrolled
2 Trials studying Leukemia
173 Patients Enrolled for Leukemia

Media Library

Patient-derived CD19- and CD22-specific CAR-T Cell Immunotherapy (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03330691 — Phase 1
~10 spots leftby Dec 2025
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