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NCT06227026 · ClinicalTrials.gov record · last posted 2026-08-26

Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CAR-T Cells) for the Treatment of Relapsed/Refractory CD19+ Malignancies

Study acronym: PRODIGY
StatusRecruiting
PhasePhase 1
Started2024-02-20
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from the ClinicalTrials.gov record
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.

Protocol amendment history 3 changes detected by DataLookout

2026-08-22
Primary completion pushed: 2026-07 → 2027-07
2026-08-22
Completion pushed: 2027-05 → 2028-05
2026-06-06
Primary completion pushed: 2026-05 → 2026-07
Trial Details
NCT Number NCT06227026
Lead Sponsor University of Utah
Collaborators: Lentigen Technology, Inc., Huntsman Cancer Institute
Conditions Acute Lymphoblastic Leukemia, Diffuse Large B Cell Lymphoma
Enrollment 10 participants
Start Date 2024-02-20
Primary Completion 2027-07 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2026-08-26