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Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)

Study acronym: SAGAN
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Interventions: 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 more Show 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
  2. Notable Primary completion date: Dec 2025 to Dec 2026v26
  3. Notable Primary completion date: Dec 2024 to Dec 2025v25
  4. Minor Site contacts updated at 2 of 2 sitesv24
  5. Minor Interventions: 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 4v23 Show 1 more changeShow less
    • Study arms: 1 to 4
Show 21 earlier versionsHide 21 earlier versions
  1. Minor Interventions: CD19 CAR T Cells (Biological), Cyclophosphamide (Drug), Fludarabine (Drug) to CD19.CAR/28 and CD19.CAR/28137 T cells (Genetic) Study arms: 4 to 1v22 Show 1 more changeShow less
    • Study arms: 4 to 1
  2. Notable Primary completion date: Dec 2022 to Dec 2024 Completion date: Feb 2034 to Feb 2036v21 Show 1 more changeShow less
    • Completion date: Feb 2034 to Feb 2036
  3. Minor Re-verified, no change to tracked fieldsv20
  4. Notable Primary completion date: Dec 2021 to Dec 2022 Completion date: Feb 2033 to Feb 2034v19 Show 1 more changeShow less
    • Completion date: Feb 2033 to Feb 2034
  5. Notable Primary completion date: Dec 2020 to Dec 2021v18
  6. Notable Primary completion date: Dec 2019 to Dec 2020v17
  7. Notable Primary completion date: Dec 2018 to Dec 2019 Eligibility criteria expanded, about 4 wordsv16 Show 1 more changeShow less
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  8. Notable Primary completion date: Feb 2018 to Dec 2018v15
  9. Minor Interventions: 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 4v14 Show 1 more changeShow less
    • Study arms: 2 to 4
  10. Notable Enrollment target: 14 to 64 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) · 2 morev13 Show 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)
    • Study description revised
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  11. Minor Eligibility criteria expanded, about 25 words Site contacts updated at 2 of 2 sitesv12 Show 1 more changeShow less
    • Site contacts updated at 2 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  12. Minor Eligibility criteria shortened, about 7 words Study description expanded, about 2 wordsv11 Show 1 more changeShow less
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  13. Minor 2 versions Re-verified since Jun 12, 2015, no change to tracked fieldsv9-v10
  14. Minor Eligibility criteria expanded, about 1 wordv8 See this version in full on ClinicalTrials.gov ↗
  15. Minor Study description expanded, about 90 words Site contacts updated at 2 of 2 sites · Eligibility criteria shortened, about 1 word · Study title expanded, about 1 wordv7 Show 3 more changesShow less
    • Site contacts updated at 2 of 2 sites
    • Eligibility criteria shortened, about 1 word
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  16. Minor Eligibility criteria expanded, about 1 wordv6 See this version in full on ClinicalTrials.gov ↗
  17. Minor Eligibility criteria shortened, about 8 wordsv5 See this version in full on ClinicalTrials.gov ↗
  18. Notable Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jan 2017 to Feb 2017 · Completion date: Jan 2032 to Feb 2032 · Start date: Jan 2014 to Feb 2014 · 1 morev4 Show 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
  19. Notable Start date: Oct 2013 to Jan 2014 Primary completion date: Oct 2016 to Jan 2017 · Completion date: Oct 2031 to Jan 2032 · Eligibility criteria expanded, about 34 words · 1 morev3 Show 4 more changesShow less
    • Primary completion date: Oct 2016 to Jan 2017
    • Completion date: Oct 2031 to Jan 2032
    • Eligibility criteria expanded, about 34 words
    • Study description shortened, about 61 words

    See this version in full on ClinicalTrials.gov ↗

  20. Notable Start date: Aug 2013 to Oct 2013 Primary completion date: Aug 2016 to Oct 2016 · Completion date: Aug 2031 to Oct 2031 · Study description revised · 3 morev2 Show 6 more changesShow less
    • Primary completion date: Aug 2016 to Oct 2016
    • Completion date: Aug 2031 to Oct 2031
    • Study description revised
    • Study sites revised (2)
    • Study title revised
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  1. Minor Study First Submitted
  • 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.
2,566 trials monitored
See 143 trials at risk
and 1 more disease
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
Conditions Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Acute Lymphocytic Leukemia
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov