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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: Completed Phase 1 study, sponsored by Joshua Brody.
NCT01976585 is a Phase 1 study that has completed, run by Joshua Brody. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Overall objective response rate at time of best response as defined by International Harmonization (Cheson) Criteria.
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 |
What the finished NCT01976585 record still lists
NCT01976585 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Poly-ICLC is the first listed.
NCT01976585 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01976585's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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