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CAR T-cell Therapy

Human-Domain CAR T Therapy for Leukemia and Lymphoma

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
Male and female subjects age ≥ 1 and ≤ 30 years
No prior virotherapy
Must not have
Presence of active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment
Presence of active severe infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 63 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment involving genetically engineering a patient's own T cells to attack their tumor.

Who is the study for?
This trial is for young individuals (1-30 years old) with CD19+ leukemia or lymphoma that hasn't responded to other treatments. They must be able to undergo apheresis, have a life expectancy of at least 8 weeks, and use effective contraception. Those with severe infections, primary immunodeficiency, active malignancies besides the study's focus, symptomatic CNS issues uncontrolled by enrollment, or active GVHD are excluded.
What is being tested?
The trial tests two versions of SCRI-huCAR19 CAR T cells designed to target CD19 on cancer cells. It aims to see if these genetically engineered T cells from patients can treat leukemia/lymphoma without being rejected by the body. The first phase checks safety; the second phase assesses effectiveness.
What are the potential side effects?
Potential side effects may include immune reactions due to cell infusion, symptoms related to organ inflammation caused by targeted cellular activity against cancerous cells expressing CD19 protein and general discomfort associated with cellular therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 1 and 30 years old.
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I have never had treatment with viruses.
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I stopped taking corticosteroids more than a week ago.
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My leukemia or lymphoma has returned after CAR T cell treatment.
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My leukemia or lymphoma is not responding to treatment and tests positive for CD19.
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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.
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I am between 18 and 30 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently being treated for or have symptoms of GVHD.
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I am currently fighting a severe infection.
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I have a primary immunodeficiency syndrome.
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I have undergone virotherapy before.
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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 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 ~63 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 63 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 CAR T cell product infusions will be assessed
The leukemia response to SCRI-huCAR19 in subjects with relapsed or refractory CD19+ leukemia 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: SCRI-huCAR19v2Experimental Treatment1 Intervention
Patients will receive SCRI-huCAR19v2 in either Phase 1 or Phase II
Group II: SCRI-huCAR19v1 - [CLOSED]Experimental Treatment1 Intervention
Patients will receive SCRI-huCAR19v1 in either Phase 1 or Phase II. As of 02/13/2020 this study cohort is permanently closed.

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor
310 Previous Clinical Trials
5,231,214 Total Patients Enrolled
12 Trials studying Leukemia
1,236 Patients Enrolled for Leukemia
Colleen Annesley, MDStudy ChairSeattle Children's Hospital
5 Previous Clinical Trials
293 Total Patients Enrolled
4 Trials studying Leukemia
281 Patients Enrolled for Leukemia

Media Library

SCRI-huCAR19v1 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03684889 — Phase 1
Leukemia Research Study Groups: SCRI-huCAR19v1 - [CLOSED], SCRI-huCAR19v2
Leukemia Clinical Trial 2023: SCRI-huCAR19v1 Highlights & Side Effects. Trial Name: NCT03684889 — Phase 1
SCRI-huCAR19v1 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03684889 — Phase 1
~2 spots leftby Nov 2025
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