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NCT01956084 · ClinicalTrials.gov registry record · Phase 1
Cytotoxic T Cells to Treat Relapsed EBV-positive Lymphoma
A Phase 1 study, sponsored by Catherine Bollard.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01956084: Completed Phase 1 study, sponsored by Catherine Bollard.
NCT01956084 is a Phase 1 study that has completed, run by Catherine Bollard. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01956084, a Phase 1 study, has completed, sponsored by Catherine Bollard.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
In this study, investigators are trying to see if LMP specific cytotoxic T lymphocytes (CTLs) will prevent or treat disease called Epstein Barr Virus (EBV) Disorder including either Hodgkin Lymphoma or non-Hodgkin Lymphoma or Lymphoepithelioma or severe chronic active EBV infection syndrome (SCAEBV) or Leiomyosarcoma which has come back or has not gone away after treatment, including the best treatment. Investigators are using special immune system cells called third party LMP specific cytotoxic T lymphocytes (CTLs), a new experimental therapy. Some patients with Lymphoma or SCAEBV or Leiomyosarcoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's and non-Hodgkin Lymphoma, suggesting that it may play a role in causing Lymphoma. The cancer cells (in lymphoma) and some B cells (in SCAEBV) infected by EBV are able to hide from the body's immune system and escape destruction. The investigators want to see if special white blood cells, called T cells, that have been trained to kill EBV infected cells can survive in patient's blood and affect the tumor or infection. Investigators used this sort of therapy to treat a different type of cancer that occurs after bone marrow or solid organ transplant called post transplant lymphoma. In this type of cancer the tumor cells have 9 proteins made by EBV on their surface. They grew T cells in the laboratory that recognized all 9 proteins and were able to successfully prevent and treat post transplant lymphoma. However in Hodgkin Lymphoma, the tumor cells and B cells only express 2 EBV proteins. In a previous study they made T cells that recognized all 9 proteins and gave them to patients with Hodgkin Lymphoma. Some patients had a partial response to this therapy but no patients had a complete response. They think one reason may be that many of the T cells reacte
Primary Outcome
Toxicity will be evaluated according to NCI Common Terminology Criteria for Adverse Events scale, version 2.0. DLT will be defined as development of any toxicity scored as Grade 3 or 4 and primarily related to the CTL infusion.
Interventions
- DRUG LMP1/2 CTLs (Group A)
- DRUG LMP1/2 CTLs (Group B)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2013-11 |
| Est. Completion | 2019-10-15 |
| Phase | Phase 1 |
What the finished NCT01956084 record still lists
NCT01956084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which LMP1/2 CTLs (Group A) is the first listed.
NCT01956084 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01956084 about?
NCT01956084 is a clinical study titled "Cytotoxic T Cells to Treat Relapsed EBV-positive Lymphoma". In this study, investigators are trying to see if LMP specific cytotoxic T lymphocytes (CTLs) will prevent or treat disease called Epstein Barr Virus (EBV) Disorder including either Hodgkin Lymphoma or non-Hodgkin Lymphoma or Lymphoepithelioma or severe chronic active EBV infection syndrome (SCAEBV)...
What is the current status of trial NCT01956084?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2013-11. Estimated completion is 2019-10-15.
What interventions are being tested in trial NCT01956084?
The interventions under investigation include: LMP1/2 CTLs (Group A) (DRUG), LMP1/2 CTLs (Group B) (DRUG).
Who is sponsoring clinical trial NCT01956084?
This trial is sponsored by Catherine Bollard, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01956084's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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