This is a Phase I, prospective, dose-finding study to evaluate the safety, persistence, and clinical activity of GF-CART01 in subjects aged 18-70 with relapsed or refractory (R/R) B-cell hematological malignancies and failure of two-line or more standard chemotherapies or auto-hematopoietic stem cell transplantation (HSCT).This study is a traditional 3+3 dose-escalation design to observe dose-limiting toxicity (DLT), establish the maximum tolerated dose(MTD)/recommended phase 2 doses (RP2D), and preliminary efficacy of GF-CART01. RP2D may equal to or lower than MTD
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
National Taiwan University Hospital
Taipei, Taiwan
RECRUITINGMaximum tolerated dose (MTD)
Percentage of subjects with dose-limiting toxicity (DLT) from Visit 4 (Day 1) to Visit 9 (Day 29) after GF-CART01 cell infusion
Time frame: From Day 1 to 28 days after cell infusion
Safety and tolerability of GF-CART01
Percentage of subjects with treatment-emergent adverse events (TEAEs), ≥ grade 3 TEAEs, serious adverse events (SAEs), adverse events of special interest (AESIs)
Time frame: From Day 1 to 1 year after cell infusion
Preliminary efficacy of GF-CART01-ORR
Measure overall response rate (ORR) from Visit 4 (Day 1) to Visit 16 (Year 1) by Lugano 2014 criteria
Time frame: From Day 1 to 1 year after cell infusion
Preliminary efficacy of GF-CART01-DOR
Measure duration of response (DOR) from Visit 4 (Day 1) to Visit 16 (Year 1) by Lugano 2014 criteria
Time frame: From Day 1 to 1 year after cell infusion
Pharmacokinetics of GF- CART01-Cmax
Measure the peak exposure (Cmax) of GF-CART01 after cell infusion
Time frame: From Day 1 to 1 year after cell infusion
Pharmacokinetics of GF- CART01-Tmax
Measure the time to reach peak exposure (Tmax) of GF-CART01 after cell infusion
Time frame: From Day 1 to 1 year after cell infusion
Pharmacokinetics of GF- CART01-pAUC
Measure the partial area under the curve (pAUC) of GF-CART01 after cell infusion
Time frame: From Day 1 to 1 year after cell infusion
Pharmacokinetics of GF- CART01-Clast
Measure the last observed measurable concentration of GF-CART01 after cell infusion
Time frame: From Day 1 to 1 year after cell infusion
Pharmacokinetics of GF- CART01-T1/2
Measure the time required for concentration of GF-CART01 to decrease by 50% after cell infusion
Time frame: From Day 1 to 1 year after cell infusion
GF-CART01 persistence
Measure the duration of GF-CART01 presence after cell infusion \- Time of Clast
Time frame: From Day 1 to 1 year after cell infusion
Feasibility of GF-CART01 production
Measure the rate of successful GF-CART01 manufacture at Visit 4 (Day 1) \- Percentage of GF-CART01 products successfully meeting manufacturing criteria
Time frame: From leukapheresis to Day 1
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