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
NON_RANDOMIZED
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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