Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AB-101 · 3 trials · 9 indications
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 |
|---|---|---|
| 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 |
|---|---|---|
| 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 |
Inclusion Criteria: General Inclusion Criteria (applicable to subjects in all 4 studied indications) 1. Males or female subjects, ≥ 18 years of age at the time of signing informed consent. 2. Ability to understand the requirements of the study. 3. Willingness to provide written informed consent. 4...