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Autologous/Allogeneic TGFbeta-resistant LMP-specific CTL, Lymphoma (TGF-beta)

Study acronym: TGF-beta
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor 8 versions Re-verified since Oct 15, 2019, no change to tracked fieldsv31-v38
  2. Minor Enrollment target: estimated 20 to confirmed 8 Secondary endpoints revised (2)v30 Show all 2 changesShow less
    • Secondary endpoints revised (2)

    See this version in full on ClinicalTrials.gov ↗

  3. Notable Primary endpoint revised Study title revisedv29 Show all 2 changesShow less
  4. Minor Primary completion date changed from estimate of Aug 2017 to Sep 2013 Interventions: TGFbeta resistant LMP-specific CTLs (Genetic) to TGFbeta resistant LMP-specific CTLs (Biological)v28 Show all 2 changesShow less
    • Interventions: TGFbeta resistant LMP-specific CTLs (Genetic) to TGFbeta resistant LMP-specific CTLs (Biological)
  5. Notable Primary completion date: Aug 2016 to Aug 2017v27
Show 25 earlier versionsHide 25 earlier versions
  1. Minor 2 versions Re-verified since Dec 30, 2015, no change to tracked fieldsv25-v26
  2. Notable Primary completion date: Jun 2015 to Aug 2016 Trial status: Recruiting to Active, Not Recruiting · Completion date: Jun 2030 to Jul 2031 · Site details revised at 2 of 2 sitesv24 Show all 4 changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Jun 2030 to Jul 2031
    • Site details revised at 2 of 2 sites
  3. Minor 2 versions Re-verified since Jul 26, 2014, no change to tracked fieldsv22-v23
  4. Minor Primary completion date: Dec 2015 to Jun 2015 Completion date: Dec 2030 to Jun 2030 · Study description shortened, about 52 words · Study sites revised (2)v21 Show all 4 changesShow less
    • Completion date: Dec 2030 to Jun 2030
    • Study description shortened, about 52 words
    • Study sites revised (2)

    See this version in full on ClinicalTrials.gov ↗

  5. Minor Interventions: TGF-b Resistant LMP2A-Specific Cytotoxic T-Lymphocytes (Genetic) to TGFbeta resistant LMP-specific CTLs (Genetic) Study description shortened, about 392 words · Site contacts updated at 2 of 2 sites · Study title shortened, about 5 wordsv20 Show all 4 changesShow less
    • Study description shortened, about 392 words
    • Site contacts updated at 2 of 2 sites
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  6. Minor Interventions: TGF-b Resistant LMP2A-Specific Cyototoxic T-Lymphocytes (Genetic) to TGF-b Resistant LMP2A-Specific Cytotoxic T-Lymphocytes (Genetic) Eligibility criteria expanded, about 53 wordsv19 Show all 2 changesShow less
    • Eligibility criteria expanded, about 53 words

    See this version in full on ClinicalTrials.gov ↗

  7. Notable Primary completion date: Dec 2025 to Dec 2015 Primary endpoints: 3 to 1 · Study sites: 3 to 2 · Completion date: Dec 2025 to Dec 2030 · 5 morev18 Show all 9 changesShow less
    • Primary endpoints: 3 to 1
    • Study sites: 3 to 2
    • Completion date: Dec 2025 to Dec 2030
    • Interventions: TGF-b RESISTANT LMP2A-SPECIFIC CYTOTOXIC T-LYMPHOCYTES (Genetic) to TGF-b Resistant LMP2A-Specific Cyototoxic T-Lymphocytes (Genetic)
    • Secondary endpoints expanded, about 19 words
    • Study description expanded, about 637 words
    • Study arms: 2 to 1
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  8. Minor Eligibility criteria revised Study description shortened, about 636 words · Site contacts updated at 2 of 3 sitesv17 Show all 3 changesShow less
    • Study description shortened, about 636 words
    • Site contacts updated at 2 of 3 sites

    See this version in full on ClinicalTrials.gov ↗

  9. Minor 4 versions Re-verified since Apr 7, 2011, no change to tracked fieldsv13-v16
  10. Minor Eligibility criteria shortened, about 47 wordsv12 Show moreShow less
  11. Minor Eligibility criteria revisedv11 Show moreShow less
  12. Minor 2 versions Re-verified since Jul 27, 2010, no change to tracked fieldsv9-v10
  13. Minor Study description shortened, about 16 wordsv8 Show moreShow less
  14. Minor 2 versions Re-verified since Apr 21, 2010, no change to tracked fieldsv6-v7
  15. Minor Study sites: 1 to 3 Eligibility criteria expanded, about 13 words · Study description expanded, about 694 wordsv5 Show all 3 changesShow less
    • Eligibility criteria expanded, about 13 words
    • Study description expanded, about 694 words

    See this version in full on ClinicalTrials.gov ↗

  16. Minor Primary and study completion dates: Dec 2025 Site contact updatedv4 Show all 2 changesShow less
    • Site contact updated
  17. Notable Primary endpoints: 2 to 3 Study arms: 0 to 2v3 Show all 2 changesShow less
  18. Minor Collaborators: 1 to 2v2 Show moreShow less
  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.
Patients have a type of lymph gland cancer called HD, NHL or lymphoepithelioma (these 3 diseases will be referred to as "Lymphoma"). The lymphoma has come back or has not gone away after treatment. This is a research study using special immune system cells called TGFb-resistant LMP-specific cytotoxic T lymphocytes (DNR-CTL), a new experimental therapy. Some patients with Lymphoma show signs of infection with the Epstein Barr virus (EBV) before or at the time of their Lymphoma diagnosis. EBV is found in the cancer cells of up to 1/2 the patients with Lymphoma, suggesting it may play a role in causing Lymphoma. The cancer cells infected by EBV are able to hide from the body's immune system and escape being killed by releasing a substance called Transforming Growth Factor-beta (TGFb). The investigators want to see if special white blood cells (called T cells) that have been given a gene that they hope will let them survive against TGFb and that have been trained to kill EBV infected cells can also survive in the blood and kill the tumor. Investigators have used this sort of therapy with specially trained T cells to treat a different type of cancer that occurs after bone marrow and solid organ transplant called post transplant lymphoma. In this type of cancer they were able to successfully prevent and treat post transplant lymphoma. However when they used a similar approach in HD some patients had a partial response to this therapy, but no patients had a complete response. In a follow-up study they tried to find out if they could improve this treatment by growing T cells that recognize 2 of the proteins expressed on Lymphoma cells called LMP-1 and LMP2a. These special T cells were called LMP-specific cytotoxic T-lymphocytes (CTLs). Although some patients had tumor responses, CTL therapy alone did not cure those who had a lot of disease. Investigators think that a reason for this is that the tumor cells are releasing TGFb. For this reason, they want to find out if they can make the CTL resistant to TGFb by putting in a new gene called TGFb resistance gene. Investigators hope that this will improve this treatment for relapsed lymphoma. These TGFb-resistant LMP-specific CTLs are an investigational product not approved by FDA. The purpose of this study is to find the largest safe dose of TGFb resistant LMP-specific CTLs, to learn what the side effects are and to see whether this therapy might help patients with Lymphoma.
Trial Details
NCT Number NCT00368082
Lead Sponsor Baylor College of Medicine
Collaborators: The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions Lymphoma, Hodgkin's Disease, Relapse, Lymphoma, Non-Hodgkin
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov