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CAR T-cell Therapy
CAR T Cell Therapy for Acute Lymphoblastic Leukemia
Phase 1
Recruiting
Led By Ibrahim Aldoss
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed CD19+ relapsed/refractory ALL with at least 2 prior lines of therapy
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
Must not have
Clinically significant uncontrolled illness
Received prior CAR T therapy within 90 days of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of cd19-car t cell infusion to the date of death or disease progression/relapse, whichever occurring first, assessed up to 15 years
Awards & highlights
Summary
This trial is testing a new therapy called huCD19-CAR T cell therapy for treating patients with a type of leukemia called B-cell acute lymphoblastic leukemia (ALL) that has not responded to
Who is the study for?
This trial is for patients with CD19 positive B-cell acute lymphoblastic leukemia that has relapsed or is refractory. Participants must have adequate organ function and no active infections. They cannot join if they've had certain recent treatments, other cancers, central nervous system involvement by leukemia, or are pregnant.
What is being tested?
The trial tests huCD19-CAR T cell therapy where a patient's immune cells are modified to attack cancer cells, combined with chemotherapy drugs fludarabine and cyclophosphamide. It aims to see if this approach is safe and effective against relapsed/refractory ALL.
What are the potential side effects?
Potential side effects include reactions at the infusion site, flu-like symptoms, changes in blood pressure or heart rate, difficulty breathing, fever, fatigue, headache and may also affect normal blood-forming cells leading to increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My leukemia has returned or didn't respond to treatment after two attempts.
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I am a woman who can have children and have a negative pregnancy test.
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I do not have seizures that are currently uncontrolled.
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My bilirubin levels are normal or slightly elevated, not due to liver cancer.
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My cancer has returned after treatment or hasn't responded to treatment.
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My liver is functioning well, with normal bilirubin and enzyme levels.
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I do not have any ongoing infections that aren't under control.
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I can have a central line placed for treatment if I don't already have one.
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I am 18 years old or older.
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I am mostly able to carry out my daily activities.
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I don't need medication to maintain my blood pressure, and I don't have uncontrolled heart issues.
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I don't need extra oxygen and my oxygen levels are above 92% without help.
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I do not need medication to maintain my blood pressure and I don't have irregular heartbeats that cause symptoms.
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I am mostly able to care for myself.
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I do not have any untreated or active infections.
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My heart condition does not severely limit my daily activities.
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I don't have a fever above 38.5°C and no recent infections.
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My blood has more than 1% CAR T cells.
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I don't need extra oxygen to maintain my oxygen levels and have no worsening lung issues on a recent chest x-ray.
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I don't need extra oxygen to maintain my oxygen levels and my chest x-ray shows no worsening issues.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any uncontrolled serious illnesses.
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I received CAR T therapy less than 3 months ago.
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I have severe heart condition limitations.
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I am currently fighting an infection that needs antibiotics.
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I had a stem cell transplant from a donor within the last 100 days.
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I do not have uncontrolled seizures, recent strokes, severe brain injuries, dementia, cerebellar disease, or psychosis.
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I have a history of HIV or hepatitis B/C.
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I am not pregnant or breastfeeding.
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I am on medication for an autoimmune disease or for graft versus host disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start of cd19-car t cell infusion to the date of death or disease progression/relapse, whichever occurring first, assessed up to 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of cd19-car t cell infusion to the date of death or disease progression/relapse, whichever occurring first, assessed up to 15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicity (DLT)
Secondary outcome measures
Duration of response (DOR)
Extramedullary relapse
Minimal residual disease (MRD)
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (huCD19-CAR T)Experimental Treatment14 Interventions
Patients undergo leukapheresis then receive lymphodepletion chemotherapy with fludarabine IV and cyclophosphamide IV on days -5, -4 and -3 and huCD19-CAR T IV cells over 10-15 minutes on day 0. Patients may optionally receive cetuximab IV over 60-120 minutes at least 28 days post T cell infusion and undergo alloHCT. Additionally, patients undergo ECHO or MUGA, CT or PET/CT and optional MRI on study and bone marrow biopsy and aspiration and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multigated Acquisition Scan
2015
Completed Phase 3
~270
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Positron Emission Tomography
2011
Completed Phase 2
~2200
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1240
Biospecimen Collection
2004
Completed Phase 3
~2020
Cetuximab
2011
Completed Phase 3
~2480
Computed Tomography
2017
Completed Phase 2
~2740
Cyclophosphamide
2010
Completed Phase 4
~2320
Echocardiography
2013
Completed Phase 4
~11580
Fludarabine
2012
Completed Phase 4
~1860
Leukapheresis
2016
Completed Phase 2
~700
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,513 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,841 Previous Clinical Trials
41,002,865 Total Patients Enrolled
Ibrahim AldossPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
92 Total Patients Enrolled
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