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CAR T-cell Therapy
CAR T-Cell Therapy for Lymphoma and Leukemia
Phase 1
Waitlist Available
Led By Nasheed Hossain, MD
Research Sponsored by Loyola University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have been diagnosed with histologically confirmed B-ALL that is refractory / recurrent.
Participants must have been diagnosed with histologically confirmed aggressive B cell NHL that is refractory / recurrent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
Study Summary
This trial is testing a new way to produce CAR+ T-cells, which are a type of cell that helps the body fight cancer. The goal is to see if this new method is better than the old one, and if so, to help reduce the side effects of cancer treatment.
Who is the study for?
Adults over 18 with certain aggressive B-cell blood cancers that have come back or didn't respond to treatment. They must be in good physical shape, with well-functioning organs and bone marrow. Pregnant women can't join, and participants should not have severe heart issues, active infections like HIV/HBV/HCV, a history of significant autoimmune diseases within the last two years, or any recent serious allergic reactions to similar drugs.Check my eligibility
What is being tested?
The trial is testing a new way to make CAR T-cells using CD19-CD34 proteins. These are special immune cells designed in the lab to fight cancer better and with fewer side effects than previous methods. Patients will also receive chemotherapy drugs Cyclophosphamide and Fludarabine before getting these modified T-cells.See study design
What are the potential side effects?
Possible side effects include flu-like symptoms, fever, fatigue, headache, muscle pain; low blood cell counts leading to increased infection risk; potential for neurological symptoms like confusion or seizures; allergic reactions during infusion; and organ inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My B-ALL cancer has not responded to treatment or has come back.
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My aggressive B cell NHL has come back or is not responding to treatment.
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It's been over 30 days since my last CAR therapy, and I don't have high levels of CAR T cells in my blood.
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I do not have an immune system disorder or a history of autoimmune disease that has caused organ damage or needed strong medication in the last 2 years.
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My kidney function is normal or only slightly impaired.
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I don't have heart issues or brain disorders in the past year.
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I am not on blood thinners.
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I am 18 years old or older.
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I am mostly active and can carry out daily activities without significant issues.
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I am capable of becoming pregnant and have a negative pregnancy test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events
Successful production of CD19-CD34 CAR product that meet predefined release criteria (cell viability/cell number/transduction efficiency/negative sterility and viral testing) for enrolled patients
Secondary outcome measures
Overall survival
Progression free survival
Response to treatment
Other outcome measures
Immune response
Trial Design
4Treatment groups
Experimental Treatment
Group I: CAR 5 x 105 transduced T cells/kg (Dose Level -1)Experimental Treatment3 Interventions
Autologous peripheral blood mononuclear cell (PBMC) will be obtained by leukapheresis over one day. Daily intravenous (IV) infusion of fludarabine and cyclophosphamide for total of 3 days (Days -5, -4, -3). The dose of cyclophosphamide will be given at 500mg/m2. The dose of fludarabine will be given at 30mg/m2. CD19-CD34 CAR transduced T cells will be administered IV at a dose level of 5 x 105 transduced T cells/kg.
Group II: CAR 2 x 106 transduced T cells/kg (Dose Level 3)Experimental Treatment3 Interventions
Autologous peripheral blood mononuclear cell (PBMC) will be obtained by leukapheresis over one day. Daily intravenous (IV) infusion of fludarabine and cyclophosphamide for total of 3 days (Days -5, -4, -3). The dose of cyclophosphamide will be given at 500mg/m2. The dose of fludarabine will be given at 30mg/m2. CD19-CD34 CAR transduced T cells will be administered IV at a dose level of 2 x 106 transduced T cells/kg.
Group III: CAR 1.5 x 106 transduced T cells/kg (Dose Level 2)Experimental Treatment3 Interventions
Autologous peripheral blood mononuclear cell (PBMC) will be obtained by leukapheresis over one day. Daily intravenous (IV) infusion of fludarabine and cyclophosphamide for total of 3 days (Days -5, -4, -3). The dose of cyclophosphamide will be given at 500mg/m2. The dose of fludarabine will be given at 30mg/m2. CD19-CD34 CAR transduced T cells will be administered IV at a dose level of 1.5 x 106 transduced T cells/kg.
Group IV: CAR 1 x 106 transduced T cells/kg (Dose Level 1)Experimental Treatment3 Interventions
Autologous peripheral blood mononuclear cell (PBMC) will be obtained by leukapheresis over one day. Daily intravenous (IV) infusion of fludarabine and cyclophosphamide for total of 3 days (Days -5, -4, -3). The dose of cyclophosphamide will be given at 500mg/m2. The dose of fludarabine will be given at 30mg/m2. CD19-CD34 CAR transduced T cells will be administered IV at a dose level of 1 x 106 transduced T cells/kg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Fludarabine
FDA approved
Find a Location
Who is running the clinical trial?
Leukemia Research FoundationUNKNOWN
Loyola UniversityLead Sponsor
156 Previous Clinical Trials
30,910 Total Patients Enrolled
Nasheed Hossain, MDPrincipal Investigator - Loyola University
Loyola University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It's been over 2 weeks or 5 half-lives since my last systemic therapy, except for immune therapy.I haven't had a heart attack or other major heart issues in the last year.My B-ALL cancer has not responded to treatment or has come back.My aggressive B cell NHL has come back or is not responding to treatment.I have been cancer-free for at least a year, except for non-melanoma skin cancer or certain in situ cancers.My cancer can be measured or seen on tests, and I have at least 5% cancer cells in my bone marrow.My kidney function is normal or only slightly impaired.I have recovered from the side effects of my previous cancer treatment.I had a stem cell transplant over 100 days ago, no GvHD, and haven't taken immunosuppressants for 30 days.It's been over 30 days since my last CAR therapy, and I don't have high levels of CAR T cells in my blood.I do not have an immune system disorder or a history of autoimmune disease that has caused organ damage or needed strong medication in the last 2 years.I don't have heart issues or brain disorders in the past year.I am not on blood thinners.I do not have any active infections.You have never had a serious allergic reaction to any similar medications or treatments used in this study.I do not have HIV, hepatitis B, or hepatitis C.My kidney, liver, lung, and heart functions are all within normal ranges.I am 18 years old or older.I am mostly active and can carry out daily activities without significant issues.My body is functioning well enough for treatment, including my organs and bone marrow.I am willing to use birth control during and for 4 months after treatment.I have ALL or B-NHL without signs of brain involvement.My liver enzymes are within acceptable limits for the trial.I am capable of becoming pregnant and have a negative pregnancy test.I had brain disease, treated successfully with no signs of coming back.I do not have active HIV or hepatitis, and no uncontrolled illnesses.
Research Study Groups:
This trial has the following groups:- Group 1: CAR 2 x 106 transduced T cells/kg (Dose Level 3)
- Group 2: CAR 1.5 x 106 transduced T cells/kg (Dose Level 2)
- Group 3: CAR 5 x 105 transduced T cells/kg (Dose Level -1)
- Group 4: CAR 1 x 106 transduced T cells/kg (Dose Level 1)
Awards:
This trial has 3 awards, including:- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Are there any vacant positions in this research project for new participants?
"The clinicaltrials.gov website indicates that this particular study is not currently recruiting patients. While this may be the case, it is worth noting that there are over 3900 other medical studies that are actively looking for participants."
Answered by AI
Could you tell me how many individuals are currently enrolled in this study?
"Unfortunately, this particular trial is not seeking new participants at this time. The original posting was on December 31st, 2019 with the most recent update on August 11th, 2020. If you are looking for other studies, there are 3032 trials for relapse and 928 trials for CD19-CD34 CAR transduced T cells that are both actively enrolling participants."
Answered by AI
Has the FDA cleared CD19-CD34 CAR transduced T cells for use?
"CD19-CD34 CAR transduced T cells have only been tested in a Phase 1 trial, so there is limited data supporting its safety."
Answered by AI
Do we have any other examples of CD19-CD34 CAR transduced T cells being used in research?
"As of now, 928 studies on CD19-CD34 CAR transduced T cells are ongoing with 165 of them being in Phase 3. Most of the research on CD19-CD34 CAR transduced T cells is conducted in Philadelphia, Pennsylvania; however, there are 28,467 locations where trials for CD19-CD34 CAR transduced T cells are taking place."
Answered by AI
What maladies does CD19-CD34 CAR transduced T cell therapy typically target?
"CAR T-cells that have been transduced with the CD19-CD34 gene are commonly used to treat multiple sclerosis. However, this same intervention can also be used for mixed-cell type lymphoma, leukemia, myelocytic, acute, and retinoblastoma."
Answered by AI
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