Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases.

PHASE1RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

May 15, 2024

Primary Completion Date

July 31, 2027

Study Completion Date

December 31, 2028

Conditions
Rheumatoid ArthritisPemphigus VulgarisGranulomatosis With PolyangiitisSystemic Lupus Erythematosus
Interventions
DRUG

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."

DRUG

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."

DRUG

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."

DRUG

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."

Trial Locations (1)

33324

RECRUITING

IRIS Research and Development, LLC, Plantation

All Listed Sponsors
collaborator

Artiva Biotherapeutics, Inc.

INDUSTRY

lead

IRIS Research and Development, LLC

OTHER