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NCT05779930 · ClinicalTrials.gov registry record · Early Phase 1
Safety and Feasibility of CD19 CAR T Cells Using CliniMACS Prodigy for Relapsed/Refractory CD19 Positive ALL and NHL
A Early Phase 1 study, sponsored by Nationwide Children's Hospital.
- Not yet
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT05779930 is a Early Phase 1 study that has not yet begun recruiting, run by Nationwide Children's Hospital. The registered enrollment target is 12 participants.
The verdict
NCT05779930, a Early Phase 1 study, has not yet begun recruiting, sponsored by Nationwide Children's Hospital.
- NOT YET RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This pilot study examines the safety and efficacy of anti-CD19 CAR T cells manufactured on-site in children and young adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma. Patients will undergo screening, leukapheresis (cell collection), lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by the anti-CD19 CAR T cell infusion. The lymphodepleting chemotherapy is administered over four days IV to prepare the body for the CAR T cells. The anti-CD19 CAR-T cells are infused between 2-14 days after the last dose of chemotherapy. This study is designed for participants to begin lymphodepleting chemotherapy during the CAR T cell manufacture and receive a fresh cell infusion on the day that manufacturing is complete. Some patients may need more time in between the cell collection and the CAR T cell infusion, therefore, the cells may be manufactured and frozen prior to administration. Patients will be followed for a year after the cell infusion on the study and for up to 15 years to monitor for potential long term side effects of cell therapy.
Interventions
- BIOLOGICAL CD19 specific Chimeric Antigen Receptor T Cell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-10 |
| Est. Completion | 2035-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05779930
The ClinicalTrials.gov registry entry for NCT05779930 describes a study currently listed as not yet recruiting, categorized as Early Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CD19 specific Chimeric Antigen Receptor T Cell is the first listed.
NCT05779930 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05779930 about?
NCT05779930 is a clinical study titled "Safety and Feasibility of CD19 CAR T Cells Using CliniMACS Prodigy for Relapsed/Refractory CD19 Positive ALL and NHL". This pilot study examines the safety and efficacy of anti-CD19 CAR T cells manufactured on-site in children and young adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma. Patients will undergo screening, leukapheresis (cell collection), ...
What is the current status of trial NCT05779930?
This trial is currently not yet recruiting. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2025-10. Estimated completion is 2035-12.
What interventions are being tested in trial NCT05779930?
The interventions under investigation include: CD19 specific Chimeric Antigen Receptor T Cell (BIOLOGICAL).
Who is sponsoring clinical trial NCT05779930?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
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