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NCT05480449 · ClinicalTrials.gov registry record · Phase 1
Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy)
A Phase 1 study of B-cell Acute Lymphoblastic Leukemia (B-ALL) and B Lineage Lymphoblastic Lymphoma, sponsored by Stephan Grupp MD PhD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 89
- Enrollment target
- 1
- Study location
NCT05480449 is a Phase 1 study of B-cell Acute Lymphoblastic Leukemia (B-ALL) and B Lineage Lymphoblastic Lymphoma that is actively recruiting participants, run by Stephan Grupp MD PhD. The registered enrollment target is 89 participants, below the 118-participant average among 6 other B-cell Acute Lymphoblastic Leukemia (B-ALL) trials with a reported enrollment target (25% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05480449, a Phase 1 study of B-cell Acute Lymphoblastic Leukemia (B-ALL) and B Lineage Lymphoblastic Lymphoma, is actively recruiting participants, sponsored by Stephan Grupp MD PhD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 89 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will determine the safety and efficacy of moving to a second-generation manufacturing process using the CliniMACS Prodigy platform to manufacture huCART19 cells for patients with B cell Acute Lymphoblastic Leukemia (B-ALL).
Conditions Studied
Interventions
- BIOLOGICAL Autologous Humanized CD19-Directed Chimeric Antigen Receptor T-Cells (huCART19)
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2022-09-20 |
| Est. Completion | 2029-09-20 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05480449
The ClinicalTrials.gov registry entry for NCT05480449 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 118-participant average among 6 other B-cell Acute Lymphoblastic Leukemia (B-ALL) trials with a reported enrollment target (25% lower). The listed sponsor is Stephan Grupp MD PhD, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with B-cell Acute Lymphoblastic Leukemia (B-ALL) appearing as the primary indexed condition, and to 1 intervention - of which Autologous Humanized CD19-Directed Chimeric Antigen Receptor T-Cells (huCART19) is the first listed.
NCT05480449 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05480449 about?
NCT05480449 is a clinical study titled "Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy)". This study will determine the safety and efficacy of moving to a second-generation manufacturing process using the CliniMACS Prodigy platform to manufacture huCART19 cells for patients with B cell Acute Lymphoblastic Leukemia (B-ALL).
What is the current status of trial NCT05480449?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 89 participants. The study started on 2022-09-20. Estimated completion is 2029-09-20.
What conditions does trial NCT05480449 study?
This clinical trial studies the following conditions: B-cell Acute Lymphoblastic Leukemia (B-ALL), B Lineage Lymphoblastic Lymphoma.
What interventions are being tested in trial NCT05480449?
The interventions under investigation include: Autologous Humanized CD19-Directed Chimeric Antigen Receptor T-Cells (huCART19) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05480449?
This trial is sponsored by Stephan Grupp MD PhD, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05480449 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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