RecruitingPhase 1NCT06227026

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


Sponsor

University of Utah

Enrollment

10 participants

Start Date

Feb 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing a type of personalized immune cell therapy called CAR-T cell therapy (using your own modified immune cells) to treat certain blood cancers that have come back or stopped responding to other treatments. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of a CD19-positive blood cancer, including non-Hodgkin lymphoma, acute lymphoblastic leukemia, or chronic lymphocytic leukemia/Richter's syndrome - Your cancer has come back or stopped responding after at least 2 prior treatment regimens - You are in adequate physical condition with acceptable organ function - You are willing to participate in a 15-year long-term follow-up study **You may NOT be eligible if...** - Your cancer is not confirmed to be CD19-positive - You have not yet tried at least 2 prior lines of treatment - Your organ function does not meet required thresholds - You have uncontrolled infections or other serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAnti-CD19 CAR-T cells

Anti-CD19 CAR-T cells are autologous T cells, engineered to express an extracellular single chain variable fragment (scFv) derived from a murine anti-human CD19 hybridoma clone FMC63 linked in frame to hinge region derived from human CD8, transmembrane domain derived from Tumor Necrosis Factor Receptor Super Family 19 (TNFRSF19) the transactivation costimulatory domain 4-1BB, and CD3 zeta signaling domain (Miltenyi Biotec Inc). Anti-CD19 CAR-T cells will be cryopreserved in infusible cryomedia for a later infusion. Anti-CD19 CAR-T cells will be administered in 1 to 3 bags. Bag aliquoting, cell content and cryomedia composition will be done according to specifications in the CMC.


Locations(1)

Huntsman Cancer Institute

Salt Lake City, Utah, United States

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NCT06227026


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