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NCT06227026 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CAR-T Cells) for the Treatment of Relapsed/Refractory CD19+ Malignancies
A Phase 1 study of Acute Lymphoblastic Leukemia and Diffuse Large B Cell Lymphoma, sponsored by University of Utah.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06227026: Recruiting Phase 1 study of Acute Lymphoblastic Leukemia and Diffuse Large B Cell Lymphoma, sponsored by University of Utah.
NCT06227026 is a Phase 1 study of Acute Lymphoblastic Leukemia and Diffuse Large B Cell Lymphoma that is actively recruiting participants, run by University of Utah. The registered enrollment target is 10 participants, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06227026, a Phase 1 study of Acute Lymphoblastic Leukemia and Diffuse Large B Cell Lymphoma, is actively recruiting participants, sponsored by University of Utah.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open label, non-randomized, phase 1 study of anti-CD19 CAR-T cells against relapsed CD19 positive NHL, CLL and ALL based in a lymphodepletion regimen (fludarabine and cyclophosphamide) and using a CellReGen-based process for manufacturing CAR-T cells. This study will utilize a staggered enrollment design with a safety observation period.
Primary Outcome
To assess the feasibility of administering CAR-T cells targeting CD19 for the treatment of relapsed/refractory B cell lymphomas, relapsed/refractory chronic lymphocytic leukemia (CLL), Richter's Syndrome, or relapsed/refractory acute lymphoblastic leukemia (ALL). Feasibility is defined as production and infusion of CAR-T therapy in 5/6 patients who have undergone successful apheresis and no more than 3/6 patients with ≥ grade 3 non-hematological CAR-T related toxicities or Events of Special Inte
Conditions Studied
Interventions
- BIOLOGICAL Anti-CD19 CAR-T cells
Study Locations (1)
Utah
- Huntsman Cancer Institute - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-02-20 |
| Est. Completion | 2027-05 |
| Phase | Phase 1 |
What NCT06227026 shows while recruiting
NCT06227026 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Anti-CD19 CAR-T cells is the first listed.
NCT06227026 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT06227026 about?
NCT06227026 is a clinical study titled "Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CAR-T Cells) for the Treatment of Relapsed/Refractory CD19+ Malignancies". This is an open label, non-randomized, phase 1 study of anti-CD19 CAR-T cells against relapsed CD19 positive NHL, CLL and ALL based in a lymphodepletion regimen (fludarabine and cyclophosphamide) and using a CellReGen-based process for manufacturing CAR-T cells. This study will utilize a staggered ...
What is the current status of trial NCT06227026?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2024-02-20. Estimated completion is 2027-05.
What conditions does trial NCT06227026 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Diffuse Large B Cell Lymphoma.
What interventions are being tested in trial NCT06227026?
The interventions under investigation include: Anti-CD19 CAR-T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT06227026?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06227026 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06227026's enrollment target sits among peer trials
10 123rd of 131 higher than 8 of 131 other Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Lymphoblastic Leukemia 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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