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NCT03843294 · ClinicalTrials.gov registry record · Phase 1
Tumor Associated Antigen Specific T Cells (TAA-T) With PD1 Inhibitor for Lymphoma
A Phase 1 study of Diffuse Large B Cell Lymphoma and Hodgkin Lymphoma, sponsored by Catherine Bollard.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT03843294: Active Phase 1 study of Diffuse Large B Cell Lymphoma and Hodgkin Lymphoma, sponsored by Catherine Bollard.
NCT03843294 is a Phase 1 study of Diffuse Large B Cell Lymphoma and Hodgkin Lymphoma that is active but no longer recruiting, run by Catherine Bollard. The registered enrollment target is 18 participants, below the 219-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03843294, a Phase 1 study of Diffuse Large B Cell Lymphoma and Hodgkin Lymphoma, is active but no longer recruiting, sponsored by Catherine Bollard.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase I, open-label multi-site trial designed to evaluate the safety of administering rapidly-generated Tumor associated antigen specific T cells (TAA-T) with the Programmed Death1 (PD-1) inhibitor Nivolumab, in relapsed/refractory lymphoma (rel/ref) patients with measurable disease (group A) or as adjunctive therapy following autologous hematopoeitic stem cell transplant(HSCT) for patients at high risk of relapse (group B). The purpose of this study is to find out if the tumor specific T cells given with Nivolumab are safe and to learn what the side effects are and if the combination can help patients with relapsed lymphomas.
Primary Outcome
Number of participants with grades 3-5 infusion-related and grades 4-5 non-hematological adverse events that are not due to the original malignancy, or pre-existing co-morbidities at least 6 weeks of the first dose of TAA-T infusion as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03, change from baseline up to week 6.
Conditions Studied
Interventions
- DRUG Nivolumab
- BIOLOGICAL TAA-T cells
Study Locations (1)
Utah
- Utah University School of Medicine/Huntsman Cancer Institute - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-06-24 |
| Est. Completion | 2026-08 |
| Phase | Phase 1 |
What the registry record for NCT03843294 still lists
NCT03843294 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 219-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT03843294 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT03843294 about?
NCT03843294 is a clinical study titled "Tumor Associated Antigen Specific T Cells (TAA-T) With PD1 Inhibitor for Lymphoma". This is a Phase I, open-label multi-site trial designed to evaluate the safety of administering rapidly-generated Tumor associated antigen specific T cells (TAA-T) with the Programmed Death1 (PD-1) inhibitor Nivolumab, in relapsed/refractory lymphoma (rel/ref) patients with measurable disease (group...
What is the current status of trial NCT03843294?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2019-06-24. Estimated completion is 2026-08.
What conditions does trial NCT03843294 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, Hodgkin Lymphoma.
What interventions are being tested in trial NCT03843294?
The interventions under investigation include: Nivolumab (DRUG), TAA-T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT03843294?
This trial is sponsored by Catherine Bollard, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03843294 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03843294's enrollment target sits among peer trials
18 99th of 114 higher than 16 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
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