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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: Clinical Trial Early Phase 1 study, sponsored by Nationwide Children's Hospital.
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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Reported as the proportion of products successfully manufactured and infused
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 |
What is known before NCT05779930 opens enrollment
NCT05779930 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which CD19 specific Chimeric Antigen Receptor T Cell is the first listed.
NCT05779930 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05779930's enrollment target sits among peer trials
12 1529th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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