NCT05963217

Phase I/Ib Study of TBI-2001 for Patients With Relapsed or Refractory CD19+ B-cell Lymphoma, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)

Study Summary

This is a Phase 1/1b, open-label, dose-escalation study to evaluate the safety and the efficacy of anti-CD19 chimeric antigen receptor (CAR) (TBI-2001) for relapsed or refractory CD19+ B-cell lymphoma Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL).

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Interventions

TBI-2001BIOLOGICAL
Phase-I portion: cohort 1: 3×10\^5 cells/kg, cohort 2: 1×10\^6 cells/kg, cohort 3: 3×10\^6 cells/kg). Phase-Ib portion: The dose of Phase-Ib will be determined during the phase I portion.
CyclophosphamideDRUG
IV Cyclophosphamide (for 3 days) will be administered as conditioning before cell infusion with TBI-2001.
FludarabineDRUG
IV Fludarabine (for 3 days) will be administered as conditioning before cell infusion with TBI-2001.

Study Locations

FacilityCityStateCountry
Princess Margaret Cancer CentreTorontoOntarioCanada

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026