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NCT03019055 · ClinicalTrials.gov registry record · Phase 1
Study of CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell
A Phase 1 study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT03019055: Completed Phase 1 study, sponsored by Medical College of Wisconsin.
NCT03019055 is a Phase 1 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03019055, a Phase 1 study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This is a phase 1/1b, interventional single arm, open label, treatment study designed to evaluate the safety and feasibility of infusion of autologous T cells engineered to contain an anti-cluster of differentiation 19 (CD19) and anti-cluster of differentiation 20 (CD20) single chain variable fragment (scFv) coupled to cluster of differentiation CD3ζ (CD3ζ) and co-stimulatory domain 4-1BB (4-1BB) signaling domains in patients with relapsed and/or refractory CD19 or CD20 positive B cell malignancies
Primary Outcome
This measure is the number of adverse events with grade 3 to 5 severity per Common Terminology Criteria for Adverse Events (ver. 4.03) occurring within the first 28 days following infusion.
Interventions
- BIOLOGICAL CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg)
- BIOLOGICAL CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg)
- BIOLOGICAL CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg)
- BIOLOGICAL CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2017-10-16 |
| Est. Completion | 2021-08-24 |
| Phase | Phase 1 |
What the finished NCT03019055 record still lists
NCT03019055 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 4 interventions - of which CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg) is the first listed.
NCT03019055 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03019055 about?
NCT03019055 is a clinical study titled "Study of CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell". This is a phase 1/1b, interventional single arm, open label, treatment study designed to evaluate the safety and feasibility of infusion of autologous T cells engineered to contain an anti-cluster of differentiation 19 (CD19) and anti-cluster of differentiation 20 (CD20) single chain variable fragme...
What is the current status of trial NCT03019055?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2017-10-16. Estimated completion is 2021-08-24.
What interventions are being tested in trial NCT03019055?
The interventions under investigation include: CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg) (BIOLOGICAL), CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg) (BIOLOGICAL), CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg) (BIOLOGICAL), CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03019055?
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 NCT03019055's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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