drugset / Trial / NCT06003179

Optimizing Lymphodepletion to Improve Outcomes in Patients Receiving Cell Therapy With Kymriah

NCT06003179 ↗

Non-randomizedSequentialOpen-labelTreatment

Summary

This is a Phase 1b study of participants with Diffuse Large B Cell Lymphoma (DLBCL). The purpose of this study is to identify an optimized lymphodepletion (LD) regimen by evaluating standard and intermediate doses of Fludarabine (Flu) / Cyclophosphamide (Cy) with or without a fixed dose of total lymphoid irradiation (TLI) in the setting of standard of care chimeric antigen receptor T (CAR T) cell therapy.

Timeline

Start
2024-04-05
Primary completion
2026-11
Completion
2028-11

Outcome

Outcome not reported

Stopped (Enrollment): “recruitment challenges and sites who initially expressed interest declined.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 250 mg/m2 —
Subject Cyclophosphamide Other / unclassified 500 mg/m2 —
Subject Cyclophosphamide Other / unclassified 750 mg/m2 —
Background Fludarabine Small molecule 25 mg/m2 —