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CAR T-cell Therapy

CAR T-Cell Therapy for Leukemia (PLAT-04 Trial)

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
Subsequent subjects: 12 months of age and <27 years of age at the time of study enrollment
If post-allogeneic hematopoetic cell transplant (HCT): confirmed CD22+ leukemia recurrence, defined as ≥0.01% disease
Must not have
Presence of any concurrent medical condition that would prevent the patient from undergoing protocol-based therapy
Unable to tolerate apheresis procedure, including placement of temporary apheresis line if required
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 the patient's own T-cells that have been genetically modified to target a different protein, CD22, that is found on the surface of the leukemia cells.

Who is the study for?
This trial is for children and young adults (12 months to <27 years old) with CD22+ leukemia or lymphoma that's come back or hasn't responded to treatment. They should have recovered from previous treatments, not be pregnant/breastfeeding, free of severe infections, other cancers, primary immunodeficiencies, and able to tolerate apheresis. Participants must agree to long-term follow-up and use effective contraception if applicable.
What is being tested?
The study tests a new therapy using the patient's own T-cells genetically modified to target CD22 on leukemia/lymphoma cells. It aims to see if these CAR T-cells are safe and can be produced in sufficient amounts for treatment in those who've relapsed after standard therapies or have resistant disease.
What are the potential side effects?
Potential side effects may include immune reactions where the body attacks its own cells (cytokine release syndrome), neurological events like confusion or seizures, allergic reactions during infusion, fatigue, fever, headache, low blood pressure, difficulty breathing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 12 months and 27 years old.
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My leukemia has returned after a stem cell transplant and tests positive for CD22.
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I need a stem cell transplant but can't have it, possibly due to remaining cancer cells.
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My lymphoma is CD22 positive and has not responded to treatment.
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I have recovered from the side effects of my previous cancer treatments.
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I have never had virotherapy.
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My leukemia didn't respond well to at least 2 different treatments.
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I can do most activities but need help with some.
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My cancer has returned in the bone marrow more than once.
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My condition has returned or didn't respond to treatment, and I haven't had a stem cell transplant from a donor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any health conditions that would stop me from following the treatment plan.
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I cannot undergo apheresis or have a temporary line placed for it.
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I am currently suffering from a severe infection.
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I have a condition that affects my immune system or bone marrow.
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I am not willing to commit to a 15-year follow-up after CAR T cell therapy.
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I have an active cancer that is not CD22+ leukemia or lymphoma.
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I have significant brain or nerve problems affecting my daily life.

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

1Treatment groups
Experimental Treatment
Group I: Autologous CD22-specific CAR T-cells expressing EGFRtExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor
310 Previous Clinical Trials
5,231,226 Total Patients Enrolled
12 Trials studying Leukemia
1,248 Patients Enrolled for Leukemia
Corinne Summers, MDStudy ChairSeattle Children's Hospital
2 Previous Clinical Trials
54 Total Patients Enrolled
1 Trials studying Leukemia
42 Patients Enrolled for Leukemia

Media Library

Patient-derived CD22-specific CAR T-cells also expressing an EGFRt (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03244306 — Phase 1
Leukemia Research Study Groups: Autologous CD22-specific CAR T-cells expressing EGFRt
Leukemia Clinical Trial 2023: Patient-derived CD22-specific CAR T-cells also expressing an EGFRt Highlights & Side Effects. Trial Name: NCT03244306 — Phase 1
Patient-derived CD22-specific CAR T-cells also expressing an EGFRt (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03244306 — Phase 1
~0 spots leftby Nov 2025
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