Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Allogeneic NK Cells, ALLONK, RITUXIMAB, CYCLOPHOSPHAMIDE, FLUDARABINE
AB-101 · 4 trials · 18 indications
Dose Limiting toxicities assessed in a incrementing dose design.
We will evaluate the Incidence of adverse events and relationship to study drug
We will evaluate the Incidence of adverse events and relationship to study drug
We will evaluate the Incidence of adverse events and relationship to study drug
Incidence, severity and causality of adverse events and serious adverse events
Determined by Overall Response Rate in subjects with lupus nephritis and refractory systemic lupus erythematosus
Based on incidence, severity, and dose relationship of AEs and serious AEs (SAEs)
Objective response rate (ORR) is defined as the proportion of patients with a documented complete response or partial response (CR + PR) in the absence of earlier disease progression.
R2PD will be determined based on safety and tolerability of AB-101 in combination with rituximab or in combination with bendamustine and rituximab.
The efficacy profile will be determined by the ORR.
| Arm | Type | Description |
|---|---|---|
| AlloNK | EXPERIMENTAL | AlloNK, dosed after a conditioning regimen, combined with Rituximab. |
| Arm 1 | EXPERIMENTAL | Arm 1 - Subjects with Rheumatoid Arthritis |
| Arm 2 | EXPERIMENTAL | Arm 2- Pemphigus Vulgaris |
| Arm 3 | EXPERIMENTAL | Arm 3 - Systemic Lupus Erythematosus |
| Arm 4 | EXPERIMENTAL | Arm 4- Subjects with Granulomatosis with polyangiitis / microscopic polyangiitis |
| Phase 1: Dose confirmation of AB-101 as Monotherapy | EXPERIMENTAL | - |
| Phase 1: Dose confirmation of AB-101 plus Obinutuzumab combination | EXPERIMENTAL | - |
| Phase 1: Dose confirmation of AB-101 plus Rituximab combination | EXPERIMENTAL | - |
| Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR combo | EXPERIMENTAL | Phase 1: Dose confirmation of AB-101 as monotherapy, in combination with rituximab (including the DLBCL specific cohort) and in combination with bendamustine and rituximab |
| Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD | EXPERIMENTAL | Phase 2: AB-101 given with rituximab or with bendamustine and rituximab to patients with B-cell NHL at the R2PD |
| Name | Type | Description |
|---|---|---|
| Allogeneic NK Cells | DRUG | AlloNK, dosed after a conditioning regimen, combined with Rituximab. |
| 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. |
| Obinutuzumab | DRUG | Anti-CD20 antibody therapy |
| Interleukin-2 | DRUG | Immune cytokine |
| Bendamustine | DRUG | Chemoimmunotherapy |
For Subjects with Refractory Rheumatoid Arthritis (RA): * Documented diagnosis of RA, meeting the 2010 ACR/EULAR classification criteria. * Rheumatoid Factor (RF) or Anti Citrullinated Protein Antibody (ACPA) positive. * High-sensitivity C-reactive protein (hs-CRP) \> 3 mg/L or Erythrocyte Sediment...
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AB-101 is an investigational allogeneic natural killer (NK) cell therapy being developed by Artiva Biotherapeutics, Inc. It is designed to be given in combination with B-cell depleting antibodies such as rituximab. It is being studied in immunology and oncology indications, including lupus nephritis, rheumatoid arthritis, and non-Hodgkin lymphoma.
AB-101 is being studied for B-cell driven diseases, including lupus nephritis (WHO Class III and IV), refractory systemic lupus erythematosus, refractory rheumatoid arthritis, pemphigus vulgaris, granulomatosis with polyangiitis, and relapsed or refractory B-cell non-Hodgkin lymphoma. It is investigational and has not been approved for any indication.
AB-101 targets CD19, a B-cell surface antigen. By engaging CD19-positive B cells alongside a B-cell depleting monoclonal antibody such as rituximab, the therapy is intended to support deeper B-cell depletion in autoimmune and B-cell lymphoma settings. CD19 is an antigen target rather than a small molecule or kinase target.
AB-101 is developed by Artiva Biotherapeutics, Inc., which trades on the Nasdaq under the ticker ARTV. Artiva is the sponsor of the clinical programs evaluating AB-101 in B-cell associated autoimmune diseases and in relapsed or refractory B-cell non-Hodgkin lymphoma.
AB-101 is in Phase 1 clinical development, with Phase 2 activity in one rheumatology study. It is investigational and has not been approved by the FDA for any indication. The program includes completed and ongoing trials across autoimmune and lymphoma indications, with a combined enrollment of approximately 90 patients in the reported studies.
AB-101 is being studied in NCT06581562, an open-label Phase 1 trial combining rituximab and AB-101 in B-cell associated autoimmune diseases, and NCT06265220, a Phase 1 trial in lupus nephritis and refractory SLE. NCT06991114 is a recruiting Phase 2 study of AlloNK with rituximab in relapsing B-cell dependent rheumatologic diseases. NCT04673617, a Phase 1 non-Hodgkin lymphoma study, is completed.
Yes. AB-101 is also referred to as allogeneic NK cells, reflecting its nature as an allogeneic, cord blood-derived natural killer cell therapy. The AlloNK name appears in the Phase 2 rheumatology study NCT06991114, which evaluates AlloNK in combination with rituximab in relapsing B-cell dependent rheumatologic diseases.