AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus

Condition(s) studied

Investigational drug(s) / intervention(s)

AB-101: NK Cell Therapy

Cyclophosphamide: Lymphodepleting chemotherapy

Fludarabine: Lymphodepleting chemotherapy

Rituximab: Anti-CD20 antibody therapy

Obinutuzumab: Anti-CD20 antibody therapy

Study summary

AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that is known to enhance the effect of monoclonal antibody therapies.

This clinical trial will enroll adult patients with lupus nephritis Class III or IV either with or without the presence of Class V who relapsed or did not respond to previous standard of care treatment approaches, or other forms of refractory systemic lupus erythematosus.

The primary objective is to assess the safety, tolerability and preliminary activity of AB-101 plus a B-cell depleting mAb (e.g., rituximab, obinutuzumab) after cyclophosphamide and fludarabine in adult subjects with relapsed/refractory lupus nephritis Class III or IV, with or without the presence of Class V, or other forms of refractory systemic lupus erythematosus.

Patients will be assigned to receive either AB-101 alone as monotherapy or in combination with a B-cell depleting mAb (e.g., rituximab, obinutuzumab). All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and response status.

Patients may receive up to 2 cycles of treatment spaced 24 weeks apart.

Eligibility

Primary outcome measure(s)

• Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events — From the time of consent through 104 weeks after initiation of study treatment
  Incidence, severity and causality of adverse events and serious adverse events
• AB-101 Clinical Activity — From the time of first dose through 104 weeks after initiation of study treatment
  Determined by Overall Response Rate in subjects with lupus nephritis and refractory systemic lupus erythematosus

Trial sites (9)

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