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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 63 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 63 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~63 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
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
306 Previous Clinical Trials
5,218,381 Total Patients Enrolled
12 Trials studying Leukemia
1,236 Patients Enrolled for Leukemia
Colleen Annesley, MDStudy ChairSeattle Children's Hospital
3 Previous Clinical Trials
275 Total Patients Enrolled
3 Trials studying Leukemia
275 Patients Enrolled for Leukemia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I took hydroxyurea more than 1 day ago.It has been over 30 days since my last CAR T cell treatment.My organs are working well.I am currently being treated for or have symptoms of GVHD.I am currently fighting a severe infection.I have a primary immunodeficiency syndrome.My leukemia or lymphoma has returned after CAR T cell treatment.My leukemia or lymphoma is not responding to treatment and tests positive for CD19.I can undergo apheresis or have enough T cells for treatment production.I can do most activities but need help with some.I have recovered from the side effects of my previous cancer treatments.It's been over a week since my last chemotherapy or biologic therapy.I do not have any active cancer other than the one being studied.I have had or currently have symptoms from a brain disorder.My leukemia or lymphoma has spread to my brain and is causing symptoms that can't be quickly controlled.I am between 18 and 30 years old.I have undergone virotherapy before.I am willing to participate in a 15-year follow-up if I receive CAR T cell therapy.I am between 1 and 30 years old.I have never had treatment with viruses.I stopped taking Tyrosine Kinase Inhibitor medication at least 3 days ago.I stopped taking corticosteroids more than a week ago.
Research Study Groups:
This trial has the following groups:- Group 1: SCRI-huCAR19v1 - [CLOSED]
- Group 2: SCRI-huCAR19v2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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