30
Participants
Start Date
May 15, 2024
Primary Completion Date
July 31, 2027
Study Completion Date
December 31, 2028
AB-101
"Subjects in all 4 indications will receive only one cycle of treatment.~Subjects with RA, PV or SLE will receive one cycle of treatment as follows:~1. Fludarabine: 25 mg/m2 on Day 1, Day 2 and Day 3.~2. Cyclophosphamide: 1000 mg/m2 on Day 3~3. Rituximab: 1000 mg on Day 1 and Day 15~4. AB-101: 1B NK cells (AlloNK) on Day 6, Day 13 and Day 20~Subjects with GPA and MPA will receive one cycle of treatment as follows:~1. Fludarabine: 25 mg/m2 on Day 1, Day 2, and Day 3.~2. Cyclophosphamide: 1000 mg/m2 on Day 3~3. Rituximab: 375 mg/m2 on Day -2, Day 6, Day 13, and Day 20~4. AB-101: 1B NK cells (AlloNK) on Day 6, Day 13, and Day 20 The first dose of AB-101 should be administered at least 48 hours after the last infusion of the lymphodepletion regimen."
Rituximab
"Subjects in all 4 indications will receive only one cycle of treatment.~Subjects with RA, PV or SLE will receive one cycle of treatment as follows:~1. Fludarabine: 25 mg/m2 on Day 1, Day 2 and Day 3.~2. Cyclophosphamide: 1000 mg/m2 on Day 3~3. Rituximab: 1000 mg on Day 1 and Day 15~4. AB-101: 1B NK cells (AlloNK) on Day 6, Day 13 and Day 20~Subjects with GPA and MPA will receive one cycle of treatment as follows:~1. Fludarabine: 25 mg/m2 on Day 1, Day 2, and Day 3.~2. Cyclophosphamide: 1000 mg/m2 on Day 3~3. Rituximab: 375 mg/m2 on Day -2, Day 6, Day 13, and Day 20~4. AB-101: 1B NK cells (AlloNK) on Day 6, Day 13, and Day 20 The first dose of AB-101 should be administered at least 48 hours after the last infusion of the lymphodepletion regimen."
Cyclophosphamide
"Subjects in all 4 indications will receive only one cycle of treatment.~Subjects with RA, PV or SLE will receive one cycle of treatment as follows:~1. Fludarabine: 25 mg/m2 on Day 1, Day 2 and Day 3.~2. Cyclophosphamide: 1000 mg/m2 on Day 3~3. Rituximab: 1000 mg on Day 1 and Day 15~4. AB-101: 1B NK cells (AlloNK) on Day 6, Day 13 and Day 20~Subjects with GPA and MPA will receive one cycle of treatment as follows:~1. Fludarabine: 25 mg/m2 on Day 1, Day 2, and Day 3.~2. Cyclophosphamide: 1000 mg/m2 on Day 3~3. Rituximab: 375 mg/m2 on Day -2, Day 6, Day 13, and Day 20~4. AB-101: 1B NK cells (AlloNK) on Day 6, Day 13, and Day 20 The first dose of AB-101 should be administered at least 48 hours after the last infusion of the lymphodepletion regimen."
Fludarabine
"Subjects in all 4 indications will receive only one cycle of treatment.~Subjects with RA, PV or SLE will receive one cycle of treatment as follows:~1. Fludarabine: 25 mg/m2 on Day 1, Day 2 and Day 3.~2. Cyclophosphamide: 1000 mg/m2 on Day 3~3. Rituximab: 1000 mg on Day 1 and Day 15~4. AB-101: 1B NK cells (AlloNK) on Day 6, Day 13 and Day 20~Subjects with GPA and MPA will receive one cycle of treatment as follows:~1. Fludarabine: 25 mg/m2 on Day 1, Day 2, and Day 3.~2. Cyclophosphamide: 1000 mg/m2 on Day 3~3. Rituximab: 375 mg/m2 on Day -2, Day 6, Day 13, and Day 20~4. AB-101: 1B NK cells (AlloNK) on Day 6, Day 13, and Day 20 The first dose of AB-101 should be administered at least 48 hours after the last infusion of the lymphodepletion regimen."
RECRUITING
IRIS Research and Development, LLC, Plantation
Lead Sponsor
Collaborators (1)
Artiva Biotherapeutics, Inc.
INDUSTRY
IRIS Research and Development, LLC
OTHER