NCT05963217View on ClinicalTrials.gov

Study of TBI-2001(Autologous CD19 Specific Chimeric Antigen Receptor (CAR) Gene-transduced T Lymphocytes) for Relapsed or Refractory CD19+ B-cell Lymphoma, CLL/SLL

PHASE1RecruitingINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

July 26, 2023

Primary Completion Date

March 30, 2026

Study Completion Date

May 30, 2026

Conditions
Relapsed or Refractory CD19+ B-cell LymphomaRelapsed or Refractory Chronic Lymphocytic LeukemiaRelapsed or Refractory Small Lymphocytic Lymphoma
Interventions
BIOLOGICAL

TBI-2001

"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."

DRUG

Cyclophosphamide

IV Cyclophosphamide (for 3 days) will be administered as conditioning before cell infusion with TBI-2001.

DRUG

Fludarabine

IV Fludarabine (for 3 days) will be administered as conditioning before cell infusion with TBI-2001.

Trial Locations (1)

M5G 2M9

RECRUITING

Princess Margaret Cancer Centre, Toronto

All Listed Sponsors
collaborator

Takara Bio Inc.

INDUSTRY

lead

University Health Network, Toronto

OTHER