Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma

Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

2. Confirmed diagnosis of active Multiple Myeloma (MM) by International Myeloma WorkingGroup (IMWG) diagnostic criteria

3. Patients must have myeloma that is response-evaluable according to the 2016 IMWGresponse criteria as defined in the protocol.

• Phase 1, Part 1 (Dose Escalation): Patients with MM who have exhausted alltherapeutic options that are expected to provide meaningful clinical benefit,either through disease relapse, treatment refractory disease or intolerance ofthe therapy and including either:a. Progression on or after at least 3 lines of therapy, or intolerance oftherapy, including a proteasome inhibitor, an Immunomodulatory agent (IMiD),and an anti-CD38 antibody, OR b. Progression on or after an anti-CD38 antibodyand have disease that is "double refractory" to a proteasome inhibitor and anIMiD, or intolerance of therapy. The anti-CD38 antibody may have beenadministered alone or in combination with another agent such as a proteasomeinhibitor (PI). Refractory disease is defined as lack of response or relapsewithin 60 days of last treatment.

• Phase 1, Part 2 (SC Administration): Patients with MM whose disease meets thefollowing criteria:a. Progression on or after at least 3 prior lines of therapy including a(n) PI,IMiD, and anti-CD38 antibody, OR b. Patients must be triple-refractory, definedas being refractory to prior treatment with at least 1 anti-CD38 antibody, aproteasome inhibitor, and an IMiD.

• Phase 2 (Cohorts 1 and 2): Patients with MM whose disease meets the following criteria: a. Progression on or after at least 3 prior lines of therapy including a(n) PI,IMiD, and anti-CD38 antibody, OR b. Patients must be triple- refractory, defined asbeing refractory* to prior treatment with at least 1 PI, 1 IMiD, and an anti-CD38antibody.

• Phase 2 (Cohort 3): Patients with MM whose disease meets the following criteria:

1. Progression on or after at least 3 prior lines of therapy including a(n) PI,IMiD, and anti-CD38 antibody, OR

2. Patients must be triple- refractory, defined as being refractory* to priortreatment with at least 1 PI, 1 IMiD, and an anti-CD38 antibody.

• Refractory disease is defined as progression during treatment or within 60days after completion of therapy, or <25% response to therapy. AND, for ALL patients, if they have relapsed after a BCMA-directed CAR-T cellulartherapy then:

• Treatment with a CAR-T must have been associated with a response of PR or better,and

• If CAR-T cellular therapy was the most recent prior therapy, excludingcorticosteroids, then treatment must have been a minimum of 60 days prior totreatment with linvoseltamab.

Key Exclusion Criteria:

1. Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis, (excluding myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 2. Patients with known MM brain lesions or meningeal involvement 3. Cardiac ejection fraction <40% by echocardiogram or multi-gated acquisition scan (MUGA) 4. Prior treatment with BCMA-directed immunotherapies, including BCMA bispecific antibodies and BiTEs. Note: BCMA antibody-drug conjugates are not excluded and BCMA-directed CAR-T treatment is not excluded in Phase 2 Cohort 3.

2. History of allogeneic stem cell transplantation at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment

Note 1: Other protocol defined inclusion / exclusion criteria apply Note 2: US sites are active but currently not enrolling