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CAR T-cell Therapy

CAR T-Cell Therapy for Leukemia and Lymphoma

Phase 1 & 2
Recruiting
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
≥ 3 days post Tyrosine Kinase Inhibitor (TKI) use
Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy, if the subject does not have a previously obtained apheresis product that is acceptable and available for manufacturing of CAR T cells
Must not have
Presence of active severe infection
Subject has received prior virotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to treat leukemia and lymphoma by using the patient's own T cells that are genetically engineered to express a CAR.

Who is the study for?
This trial is for young individuals up to 30 years old with stubborn leukemia or lymphoma that hasn't responded to other treatments. They must have a certain protein (CD22) on their cancer cells, be able to handle the procedure to collect immune cells, and not be pregnant or breastfeeding. Those who've had previous CAR T cell therapy can join if they meet other health requirements.
What is being tested?
The study tests genetically modified T cells targeting CD22 in patients with tough-to-treat leukemia or lymphoma. It's split into two parts: first finding a safe dose of these CAR T cells and then checking how well they work against the cancer.
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells by mistake, symptoms from high fevers, difficulty breathing, feeling very tired, confusion, nausea, headaches and drops in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I stopped using Tyrosine Kinase Inhibitors at least 3 days ago.
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I have recovered from the side effects of my previous cancer treatments.
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My leukemia or lymphoma is not responding to treatment and tests positive for CD22.
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I can undergo apheresis or have enough T cells for treatment production.
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I can do most activities but need help with some.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently suffering from a severe infection.
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I have previously undergone virotherapy.
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My cancer cells all show CD19 and I haven't tried CD19 CAR T cell therapy.
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I am willing to participate in a 15-year follow-up if I receive CAR T cell therapy.
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I have a primary immunodeficiency syndrome.
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I have had a stem cell transplant and am currently dealing with or being treated for GVHD.
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I do not have any active cancer other than the one being studied.
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I have had or currently have symptoms from a brain disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 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 ability to successfully manufacture SCRI-CAR22v2
The leukemia response to SCRI-CAR22v2 in subjects with relapsed or refractory CD22+ leukemia will be assessed
he adverse events associated with CAR T cell product infusions 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: SCRI-CAR22v2Experimental Treatment1 Intervention
Patients will receive SCRI-CAR22v2 in either Phase I or Phase II

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor
310 Previous Clinical Trials
5,231,188 Total Patients Enrolled
12 Trials studying Leukemia
1,210 Patients Enrolled for Leukemia
Corinne Summers, MDStudy ChairSeattle Children's Hospital
2 Previous Clinical Trials
16 Total Patients Enrolled
1 Trials studying Leukemia
4 Patients Enrolled for Leukemia

Media Library

SCRI-CAR22v2 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04571138 — Phase 1 & 2
Leukemia Research Study Groups: SCRI-CAR22v2
Leukemia Clinical Trial 2023: SCRI-CAR22v2 Highlights & Side Effects. Trial Name: NCT04571138 — Phase 1 & 2
SCRI-CAR22v2 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04571138 — Phase 1 & 2
~4 spots leftby Jun 2025
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