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

Conditions

• Granulomatosis With Polyangiitis
• Pemphigus Vulgaris
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AB-101 — DRUG
  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 — DRUG
  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 — DRUG
  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 — DRUG
  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.

Study Details

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.

Key Dates

Start date

May 15, 2024

Status verified

Aug 2024

Primary completion

Jul 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

30 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1
  Arm 1 - Subjects with Rheumatoid Arthritis
• Experimental: Arm 2
  Arm 2- Pemphigus Vulgaris
• Experimental: Arm 3
  Arm 3 - Systemic Lupus Erythematosus
• Experimental: Arm 4
  Arm 4- Subjects with Granulomatosis with polyangiitis / microscopic polyangiitis

Primary Outcome Measure

Incidence of adverse events and relationship to study drug [ Time Frame: From the time of consent through 104 weeks after initiation of study treatment ]

Central Contacts

• Kathy I Perez, M.D.
  954-476-2338
  [email protected]
• Jhon Galindo, B.S.
  9544762338
  [email protected]

Locations (1)

Find similar trials in Plantation, FL

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