Phase 1/2 study to determine the safety, pharmacokinetics, and efficacy of single agent CC-122 and the combinations of CC-122 and ibrutinib and CC-122 and obinutuzumab in subjects with chronic lymphocytic leukemia/small lymphocytic lymphoma

• ECOG PS 0-1

• Age 18-80 years old

• Must have CLL/SLL requiring treatment per Hallek, 2008

• Must have at least one clinically measurable lesions defined as

  • Nodal lesion measuring >1.5cm in longest diameter and >1.0cm in longest perpendicular diameter OR

  • Spleen measuring >14cm in longest vertical dimension with a minimum of 2 cm enlargement OR

  • Liver measuring >20 cm in longest vertical dimenstion with a minimum of 2 cm of enlargement OR

  • Peripheral blood B lymphocyte count >5000/uL

• For single agent and obinutuzumab combo must have relapsed refractory disease as follows:

  • Must have received either prior chemoimmunotherapy or therapy with an approved BTK inhibitor unless significant co-morbidities or contraindications

• For ibrutinib combo arm, must have not received prior treatment with ibrutinib or BTK inhibitors and must have high-risk disease defined as follows:

  • 17p- and/or TP53 mutation positive in treatment naïve CLL OR

  • 17p- and/or TP53 mutation positive, and/or complex karyotype and/or progression <24 months after completion of 1st line chemoimmunotherapy in relapsed/refractory CLL

• Subjects with R/R SLL or CLL with bulky disease (LN>5.0cm) may only be enrolled after discussion with sponsor medical monitor

• Must have adequate lab values

• No prior allo or auto SCT within 12 months

• No known HIV/HBV/HCV

• No significant peripheral neuropathy

• No impaired cardiac function

Primary- DLT, MTD: Secondary- ORR, PK, DoR, PFS

CC-122 daily in 28 day cycles, alone or in combination