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MinorInterventions: Dose Escalation Phase:CD19.CAR/28 and CD19.CAR/28137 T cells (Genetic), Expansion Phase: CD19.CAR/28 and CD19.CAR/28137 T cells (Genetic) to Dose Escalation Phase:CD19.CAR/28 and CD19.CAR/28137 T cells (Genetic), Expansion Phase: CD19.CAR/28 and CD19.CAR/28137 T cells (Genetic)Secondary endpoints: details revised at 2 of 5 entries · Site details revised at 2 of 2 sites · Publications: details revised at 1 of 1 entry · 1 moreShow 4 more changesShow less
Secondary endpoints: details revised at 2 of 5 entries
Site details revised at 2 of 2 sites
Publications: details revised at 1 of 1 entry
Eligibility criteria expanded, about 1 word
NotablePrimary completion date: Dec 2025 to Dec 2026v26
NotablePrimary completion date: Dec 2024 to Dec 2025v25
MinorSite contacts updated at 2 of 2 sitesv24
MinorInterventions: CD19.CAR/28 and CD19.CAR/28137 T cells (Genetic) to Dose Escalation Phase:CD19.CAR/28 and CD19.CAR/28137 T cells (Genetic), Expansion Phase: CD19.CAR/28 and CD19.CAR/28137 T cells (Genetic)Study arms: 1 to 4v23Show 1 more changeShow less
Study arms: 1 to 4
Show 21 earlier versionsHide 21 earlier versions
MinorInterventions: CD19 CAR T Cells (Biological), Cyclophosphamide (Drug), Fludarabine (Drug) to CD19.CAR/28 and CD19.CAR/28137 T cells (Genetic)Study arms: 4 to 1v22Show 1 more changeShow less
Study arms: 4 to 1
NotablePrimary completion date: Dec 2022 to Dec 2024Completion date: Feb 2034 to Feb 2036v21Show 1 more changeShow less
Completion date: Feb 2034 to Feb 2036
MinorRe-verified, no change to tracked fieldsv20
NotablePrimary completion date: Dec 2021 to Dec 2022Completion date: Feb 2033 to Feb 2034v19Show 1 more changeShow less
Completion date: Feb 2033 to Feb 2034
NotablePrimary completion date: Dec 2020 to Dec 2021v18
NotablePrimary completion date: Dec 2019 to Dec 2020v17
NotablePrimary completion date: Dec 2018 to Dec 2019Eligibility criteria expanded, about 4 wordsv16Show 1 more changeShow less
NotablePrimary completion date: Feb 2018 to Dec 2018v15
MinorInterventions: CD19 Specific CAR T Cells (Biological), CD19 Specific CAR T Cells Fixed Dose (Biological) to CD19 CAR T Cells (Biological), Cyclophosphamide (Drug), Fludarabine (Drug)Study arms: 2 to 4v14Show 1 more changeShow less
Study arms: 2 to 4
NotableEnrollment target: 14 to 64Primary completion date: Feb 2017 to Feb 2018 · Completion date: Feb 2032 to Feb 2033 · Interventions: CD19 Specific CAR T Cells (Biological) to CD19 Specific CAR T Cells (Biological), CD19 Specific CAR T Cells Fixed Dose (Biological) · 2 morev13Show 5 more changesShow less
Primary completion date: Feb 2017 to Feb 2018
Completion date: Feb 2032 to Feb 2033
Interventions: CD19 Specific CAR T Cells (Biological) to CD19 Specific CAR T Cells (Biological), CD19 Specific CAR T Cells Fixed Dose (Biological)
MinorStudy description expanded, about 90 wordsSite contacts updated at 2 of 2 sites · Eligibility criteria shortened, about 1 word · Study title expanded, about 1 wordv7Show 3 more changesShow less
NotableTrial status: Not Yet Recruiting to RecruitingPrimary completion date: Jan 2017 to Feb 2017 · Completion date: Jan 2032 to Feb 2032 · Start date: Jan 2014 to Feb 2014 · 1 morev4Show 4 more changesShow less
Primary completion date: Jan 2017 to Feb 2017
Completion date: Jan 2032 to Feb 2032
Start date: Jan 2014 to Feb 2014
Site details revised at 2 of 2 sites
NotableStart date: Oct 2013 to Jan 2014Primary completion date: Oct 2016 to Jan 2017 · Completion date: Oct 2031 to Jan 2032 · Eligibility criteria expanded, about 34 words · 1 morev3Show 4 more changesShow less
NotableStart date: Aug 2013 to Oct 2013Primary completion date: Aug 2016 to Oct 2016 · Completion date: Aug 2031 to Oct 2031 · Study description revised · 3 morev2Show 6 more changesShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Subjects on this study have a type of lymph gland cancer called Non-Hodgkin Lymphoma, acute lymphocytic leukemia, or chronic Lymphocytic Leukemia (these diseases will be referred to as "lymphoma" or "leukemia"). The lymphoma or leukemia has come back or has not gone away after treatment.
The body has different ways of fighting infection and disease. No one way seems perfect for fighting cancers. This research study combines two different ways of fighting disease, antibodies and T cells, hoping that they will work together. Both antibodies and T cells have been used to treat patients with cancer. They have shown promise, but have not been strong enough to cure most patients.
T cells can kill tumor cells but normally there are not enough of them to kill all the tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person.
The antibody used in this study is called anti-CD19. It first came from mice that have developed immunity to human lymphoma. This antibody sticks to lymphoma cells because of a substance on the outside of these cells called CD19. CD19 antibodies have been used to treat people with lymphoma and leukemia. For this study, anti-CD19 has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor.
In the laboratory, the investigators found that T cells work better if they also add proteins that stimulate T cells, such as one called CD28. Adding the CD28 makes the cells last longer in the body but not long enough for them to be able to kill the lymphoma cells. The investigators believe that if they add an extra stimulating protein, called CD137, the cells will have a better chance of killing the lymphoma cells.
The investigators are going to see if this is true by putting the CD19 chimeric receptor with CD28 alone into half of the cells and the CD19 chimeric receptor with CD28 and CD137 into the other half of the cells. These CD19 chimeric receptor T cells with CD28 and with or without CD137 are investigational products not approved by the FDA.
The purpose of this study is to find the biggest dose of chimeric T cells that is safe, to see how long the T cell with each sort of chimeric receptor lasts, to learn what the side effects are and to see whether this therapy might help people with lymphoma or leukemia.
Trial Details
NCT Number
NCT01853631
Lead Sponsor
Baylor College of Medicine Collaborators: Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute