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

Summary

This study will evaluate the safety and activity of AB-101 in combination with rituximab in B-cell associated autoimmune diseases where rituximab is currently FDA approved (e.g., Rheumatoid Arthritis (RA), Pemphigus Vulgaris (PV), Granulomatosis with polyangiitis (GPA)/microscopic polyangiitis (MPA) as a therapeutic, or is recommended (e.g., in Systemic Lupus Erythematosus (SLE) as a cornerstone for disease management.

Conditions

• Rheumatoid Arthritis
• Pemphigus Vulgaris
• Granulomatosis With Polyangiitis
• Systemic 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.

Sponsors & Collaborators

• Artiva Biotherapeutics, Inc.

  collaborator INDUSTRY

• IRIS Research and Development, LLC

  lead OTHER

Principal Investigators

• Guillermo J. Valenzuela, M.D. · IRIS Research and Development, LLC

• Kathy I. Perez, M.D. · IRIS Research and Development, LLC

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-15

Primary Completion

2027-07-31

Completion

2028-12-31

FDA Drug

Yes

Countries

• United States

Study Locations