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NCT04544592 · ClinicalTrials.gov registry record · Phase 1
UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL
A Phase 1 study of B-Cell Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT04544592: Recruiting Phase 1 study of B-Cell Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia, sponsored by University of Colorado, Denver.
NCT04544592 is a Phase 1 study of B-Cell Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 45 participants, below the 128-participant average among 24 other B-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04544592, a Phase 1 study of B-Cell Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial will investigate a new CD19 directed CAR-T therapy manufactured locally with the goals to expedite infusion to wider patient inclusion that includes those who were previously excluded, such as pediatric patients with B-cell NHL and patients in primary relapse.
Primary Outcome
DLTs of UCD19 CAR-T will be assessed at each of the dose levels in a standard 3+3 dose-escalation design with a determination of recommended Phase 2 dose (RP2D).
Conditions Studied
Interventions
- DRUG CD19CAR-CD3Zeta-4-1BB-Expressing Autologous T-Lymphocyte Cells
Study Locations (1)
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2021-03-10 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
What NCT04544592 shows while recruiting
NCT04544592 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 128-participant average among 24 other B-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (65% lower).
The record links to 2 conditions, with B-Cell Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which CD19CAR-CD3Zeta-4-1BB-Expressing Autologous T-Lymphocyte Cells is the first listed.
NCT04544592 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT04544592 about?
NCT04544592 is a clinical study titled "UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL". This phase I/II trial will investigate a new CD19 directed CAR-T therapy manufactured locally with the goals to expedite infusion to wider patient inclusion that includes those who were previously excluded, such as pediatric patients with B-cell NHL and patients in primary relapse.
What is the current status of trial NCT04544592?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2021-03-10. Estimated completion is 2026-07.
What conditions does trial NCT04544592 study?
This clinical trial studies the following conditions: B-Cell Non-Hodgkin Lymphoma, B-cell Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT04544592?
The interventions under investigation include: CD19CAR-CD3Zeta-4-1BB-Expressing Autologous T-Lymphocyte Cells (DRUG).
Who is sponsoring clinical trial NCT04544592?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04544592 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for B-Cell Non-Hodgkin Lymphoma
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 NCT04544592's enrollment target sits among peer trials
45 16th of 24 higher than 9 of 24 other B-Cell Non-Hodgkin Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other B-Cell Non-Hodgkin Lymphoma 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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