Study of bb21217 in Multiple Myeloma

Study CRB-402 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb21217 in adults with relapsed/refractory multiple myeloma (MM).

Inclusion Criteria:

- ≥18 years of age at the time of signing informed consent

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Diagnosis of MM with relapsed or refractory disease and have had at least 3 different prior lines of therapy with previous exposure to PI, IMiDs, and a CD38 antibody. Have undergone at least 2 consecutive cycles of treatment for each therapy, unless PD was the best response to the therapy. Refractory to their last line of therapy.

- Subjects must have measurable disease

Exclusion Criteria:

- Subjects with known central nervous system disease

- Inadequate hepatic function

- Inadequate renal function

- Inadequate bone marrow function

- Presence of active infection within 72 hours

- Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control

- Significant co-morbid condition or disease which in the judgment of the Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions

- Known human immunodeficiency virus (HIV) positivity

- Known hepatitis A virus (HAV), hepatitis B virus (HBV) or hepatitis C virus (HCV) positivity with evidence of ongoing infection.

- Pregnant or lactating women

- Previous history of an allogeneic bone marrow transplantation, treatment with any gene therapy based therapeutic for cancer, or BCMA-targeted therapy

- Inadequate pulmonary function defined as oxygen saturation (SaO2) <92% on room air

- Subjects who have a history of plasma cell leukemia, active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS, or clinically significant amyloidosis

Conditions:
• Multiple Myeloma
• Neoplasms, Plasma Cell