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NCT03652545 · ClinicalTrials.gov registry record · Phase 1
Multi-antigen T Cell Infusion Against Neuro-oncologic Disease
A Phase 1 study of Brain Tumor, sponsored by Catherine Bollard.
- Active
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT03652545: Active Phase 1 study of Brain Tumor, sponsored by Catherine Bollard.
NCT03652545 is a Phase 1 study of Brain Tumor that is active but no longer recruiting, run by Catherine Bollard. The registered enrollment target is 33 participants, below the 281-participant average among 69 other Brain Tumor trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03652545, a Phase 1 study of Brain Tumor, is active but no longer recruiting, sponsored by Catherine Bollard.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
This Phase I dose-escalation trial is designed to determine the safety and feasibility of rapidly generated tumor multi-antigen associated specific cytotoxic T lymphocytes (TAA-T) in patients with newly diagnosed diffuse intrinsic pontine gliomas DIPGs (Group A) or recurrent, progressive, or refractory non-brainstem CNS malignancies (Group B). Pediatric and adult patients who have high-risk CNS tumors known to typically have positivity for one or more Tumor Antigen Associated (TAA) (WT1, PRAME and/or Survivin) will be eligible. TAA-T will all be generated from patient peripheral blood mononuclear cells (PBMC). Group A patients (DIPG): The first TAA-T dose will be infused any time 14 days or more after completion of radiotherapy. Group B patients (other recurrent/progressive/refractory CNS tumors): The first TAA-T dose will be infused any time 14 days or more after completing most recent course of conventional (non-investigational) therapy for their disease AND after appropriate washout periods as detailed in eligibility criteria.
Primary Outcome
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.03, change from Baseline Infusion related toxicity at 42 days.
Conditions Studied
Interventions
- BIOLOGICAL TAA-T
Study Locations (1)
District of Columbia
- Brain Tumor Institute, Children's National Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2018-12-12 |
| Est. Completion | 2028-12 |
| Phase | Phase 1 |
What the registry record for NCT03652545 still lists
NCT03652545 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 281-participant average among 69 other Brain Tumor trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Brain Tumor appearing as the primary indexed condition, and to 1 intervention - of which TAA-T is the first listed.
NCT03652545 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT03652545 about?
NCT03652545 is a clinical study titled "Multi-antigen T Cell Infusion Against Neuro-oncologic Disease". This Phase I dose-escalation trial is designed to determine the safety and feasibility of rapidly generated tumor multi-antigen associated specific cytotoxic T lymphocytes (TAA-T) in patients with newly diagnosed diffuse intrinsic pontine gliomas DIPGs (Group A) or recurrent, progressive, or refract...
What is the current status of trial NCT03652545?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2018-12-12. Estimated completion is 2028-12.
What conditions does trial NCT03652545 study?
This clinical trial studies the following conditions: Brain Tumor.
What interventions are being tested in trial NCT03652545?
The interventions under investigation include: TAA-T (BIOLOGICAL).
Who is sponsoring clinical trial NCT03652545?
This trial is sponsored by Catherine Bollard, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03652545 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03652545's enrollment target sits among peer trials
33 39th of 69 higher than 29 of 69 other Brain Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Tumor 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.
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