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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
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
302 Previous Clinical Trials
5,216,682 Total Patients Enrolled
12 Trials studying Leukemia
1,210 Patients Enrolled for Leukemia
Corinne Summers, MDStudy ChairSeattle Children's Hospital
1 Previous Clinical Trials
4 Total Patients Enrolled
1 Trials studying Leukemia
4 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently suffering from a severe infection.I have previously undergone virotherapy.It's been over a week since my last chemotherapy or biologic therapy.My cancer cells all show CD19 and I haven't tried CD19 CAR T cell therapy.I stopped using Tyrosine Kinase Inhibitors at least 3 days ago.My organs are working well.I am 30 years old or younger.I have recovered from the side effects of my previous cancer treatments.I stopped taking corticosteroids more than a week ago.My leukemia or lymphoma has spread to my brain and is causing symptoms that can't be quickly controlled.I took hydroxyurea more than 1 day ago.My leukemia or lymphoma is not responding to treatment and tests positive for CD22.I am willing to participate in a 15-year follow-up if I receive CAR T cell therapy.It has been over 30 days since my last CAR T cell treatment.I have a primary immunodeficiency syndrome.I can undergo apheresis or have enough T cells for treatment production.I have had a stem cell transplant and am currently dealing with or being treated for GVHD.I can do most activities but need help with some.I do not have any active cancer other than the one being studied.I have had or currently have symptoms from a brain disorder.
Research Study Groups:
This trial has the following groups:- Group 1: SCRI-CAR22v2
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are included in this clinical experiment?
"This clinical trial necessitates the participation of 42 qualified patients. Potential participants can be found in Riley Hospital for Children, Indianapolis and likewise at Children's National Hospital located in Washington DC."
Answered by AI
How many healthcare facilities are administering this trial?
"This paediatric trial is being administered from Riley Hospital for Children in Indianapolis, Indiana, alongside five other research centres. Moreover, Children's National Hospital in Washington D.C and Children's Hospital Los Angeles are also partnering with this endeavour."
Answered by AI
Are there any open enrollment slots available for this clinical trial?
"Data from clinicaltrials.gov indicates that this medical trial is actively seeking participants, having been first published on September 25th 2020 and most recently updated on April 2nd 2022."
Answered by AI
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