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NCT04049383 · ClinicalTrials.gov registry record · Phase 1
CAR-20/19-T Cells in Patients With Relapsed/Refractory B Cell ALL
A Phase 1 study, sponsored by Medical College of Wisconsin.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT04049383: Clinical Trial Phase 1 study, sponsored by Medical College of Wisconsin.
NCT04049383 is a Phase 1 study that was terminated before completion, run by Medical College of Wisconsin. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04049383, a Phase 1 study, was terminated before completion, sponsored by Medical College of Wisconsin.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This phase 1 study will evaluate the safety and efficacy of a CAR-T cell therapy directed against two B cell antigens (CD19 CD20) and produced under good manufacturing practice (GMP) conditions using the closed system CliniMACS Prodigy device in B ALL.
Primary Outcome
Adverse events will be measured and recorded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Occurrence of adverse events, defined as either CRS related Grade 3/4 toxicity or other NCI CTCAE version 5 non-hematologic ≥ grade 3 signs/symptoms, laboratory toxicities and clinical events that are possibly, probably or definitely related to study treatment at any time from the infusion until day +28 post CAR-T infusion.
Interventions
- BIOLOGICAL CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg)
- BIOLOGICAL CAR-20/19-T cells (5 x 10^5 CAR-20/19-T cells/kg)
- BIOLOGICAL CAR-20/19-T cells (1 x10^6 CAR-20/19-T cells/kg)
- BIOLOGICAL CAR-20/19-T cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-10-16 |
| Est. Completion | 2025-09-01 |
| Phase | Phase 1 |
Why NCT04049383 stopped before completion
NCT04049383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 4 interventions - of which CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg) is the first listed.
NCT04049383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04049383 about?
NCT04049383 is a clinical study titled "CAR-20/19-T Cells in Patients With Relapsed/Refractory B Cell ALL". This phase 1 study will evaluate the safety and efficacy of a CAR-T cell therapy directed against two B cell antigens (CD19 CD20) and produced under good manufacturing practice (GMP) conditions using the closed system CliniMACS Prodigy device in B ALL.
What is the current status of trial NCT04049383?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2020-10-16. Estimated completion is 2025-09-01.
What interventions are being tested in trial NCT04049383?
The interventions under investigation include: CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg) (BIOLOGICAL), CAR-20/19-T cells (5 x 10^5 CAR-20/19-T cells/kg) (BIOLOGICAL), CAR-20/19-T cells (1 x10^6 CAR-20/19-T cells/kg) (BIOLOGICAL), CAR-20/19-T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT04049383?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04049383's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 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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