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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GF-CART01 | Experimental | CAR-positive viable T cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GF-CART01 | Biological | CAR positive viable T cells-Mid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum 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 | 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) | From Day 1 to 1 year after cell infusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From Day 1 to 1 year after cell infusion |
| Preliminary efficacy of GF-CART01-DOR |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of cytokines in peripheral blood | Measure the levels of circulating cytokines at each time point throughout the study period | From Day 1 to 1 year after cell infusion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Howard Cheng | Contact | +886-2-2655-8766 | howardcheng@genomefrontier.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
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| GF-CART01 |
| Biological |
CAR positive viable T cells-High |
|
| GF-CART01 | Biological | CAR positive viable T cells-Low |
|
Measure duration of response (DOR) from Visit 4 (Day 1) to Visit 16 (Year 1) by Lugano 2014 criteria
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | From leukapheresis to Day 1 |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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