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NCT01976585 · ClinicalTrials.gov registry record · Phase 1
In Situ Vaccine for Low-Grade Lymphoma: Combination of Intratumoral Flt3L and Poly-ICLC With Low-Dose Radiotherapy
A Phase 1 study, sponsored by Joshua Brody.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT01976585 is a Phase 1 study that has completed, run by Joshua Brody. The registered enrollment target is 21 participants.
The verdict
NCT01976585, a Phase 1 study, has completed, sponsored by Joshua Brody.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
Our recent trials combining local radiotherapy with intratumoral administration of TLR agonists - referred to as 'in situ vaccination' - for patients with low-grade lymphoma demonstrated safety, induction of anti-tumor CD8 T cell responses and partial and complete remissions of patients' non-irradiated sites of disease with complete remissions lasting from months to more than three years. This iteration of the in situ vaccine approach builds on our prior work in ways that should improve its efficacy, by adding Flt3L and changing the toll-like receptors (TLR) agonist to poly-ICLC -an optimal TLR agonist for the type of dendritic cells (DC) recruited by Flt3L. The vaccine is thus in 3 phases: 1. intratumoral Flt3L administration recruits DC to the tumor 2. low-dose radiotherapy to release tumor antigens 3. intratumoral poly-ICLC administration activates tumor-antigen loaded DC
Interventions
- DRUG Poly-ICLC
- DRUG rhuFlt3L/CDX-301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2014-01-03 |
| Est. Completion | 2020-11-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01976585
The ClinicalTrials.gov registry entry for NCT01976585 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Joshua Brody, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Poly-ICLC is the first listed.
NCT01976585 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01976585 about?
NCT01976585 is a clinical study titled "In Situ Vaccine for Low-Grade Lymphoma: Combination of Intratumoral Flt3L and Poly-ICLC With Low-Dose Radiotherapy". Our recent trials combining local radiotherapy with intratumoral administration of TLR agonists - referred to as 'in situ vaccination' - for patients with low-grade lymphoma demonstrated safety, induction of anti-tumor CD8 T cell responses and partial and complete remissions of patients' non-irradia...
What is the current status of trial NCT01976585?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2014-01-03. Estimated completion is 2020-11-20.
What interventions are being tested in trial NCT01976585?
The interventions under investigation include: Poly-ICLC (DRUG), rhuFlt3L/CDX-301 (DRUG).
Who is sponsoring clinical trial NCT01976585?
This trial is sponsored by Joshua Brody, which has 2 total clinical trials registered on ClinicalTrials.gov.
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