The purpose of this study is to assess the therapeutic efficacy of mosunetuzumab, a bispecific antibody targeting CD20 and CD3 in patients who have detectable chronic lymphocytic leukemia (CLL) after receiving Bruton's tyrosine kinase inhibitors (BTKis) for at least 6 months and have no clinical or laboratory evidence of disease progression.
Age ≥18 years at the time of signing the Informed Consent Form
Ability to comply with the study protocol and procedures and required
Patients must have received ≥2 prior lines of systemic therapy, including the current BTKi
Platelet count ≥50,000/µL; in cases of thrombocytopenia clearly due to marrow involvement of CLL (per the discretion of the investigator), platelet count should be
Patients with high disease burden, defined as having either absolute lymphocyte count >5 x 109 cells/L, or largest lymph node >2 cm, or bone marrow with >50% CLL involvement
Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab and tocilizumab (if applicable). Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment. If a serum pregnancy test has not been performed within 14 days prior to receiving first study treatment, a negative urine pregnancy test result (performed within 7 days prior to study treatment) must be available.
Treatment with mosunetuzumab or other CD20/CD3-directed bispecific antibodies
Radiotherapy within 2 weeks prior to the first dose of study treatment
M.D. Anderson Cancer Center
Lead sponsor
Genentech, Inc.
Collaborator