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).
TBI-2001 is a next-generation CAR-T product including costimulatory sequences that lead to the activation of cytokine-related JAK/STAT signaling pathways. This is a first-in-human study of TBI-2001 and will follow a 3+3 design of dose-escalation cohorts. Additional subjects will be treated with TBI-2001 at the determined recommended phase 2 dose (RP2D) following cyclophosphamide and fludarabine pre-treatment. Long-term follow-up is conducted for 5 years following the infusion of TBI-2001
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
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.
IV Cyclophosphamide (for 3 days) will be administered as conditioning before cell infusion with TBI-2001.
IV Fludarabine (for 3 days) will be administered as conditioning before cell infusion with TBI-2001.
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITINGSafety of TBI-2001
Dose Limiting Toxicities (DLTs)
Time frame: One month
Safety of TBI-2001
Adverse event (AEs)
Time frame: One year
Safety of TBI-2001
Laboratory testing- RCR appearance and Clonality
Time frame: One year
Recommended phase 2 dose (RP2D) of TBI-2001
RP2D to be determined during the dose escalation cohort
Time frame: One year
Efficacy of TBI-2001; Overall Response Rate (ORR)
Overall Response Rate (ORR) (Complete Response (CR)+Partial Response(PR))
Time frame: One year
Efficacy of TBI-2001; Durable Response Rate (DRR)
Durable Response Rate (DRR) as defined as CR or PR sustained for at least 6 months
Time frame: One year
Efficacy of TBI-2001; Progression free survival (PFS)
Progression free survival
Time frame: One year
Efficacy of TBI-2001; Overall survival (OS)
Overall survival
Time frame: One year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.