C1071005 (MAGNETISMM-5)

MM with measurable disease, ECOG ≤2, and 1–3 prior lines (including lenalidomide and a PI) with at least a minimal response to one past treatment. Adequate cardiac, renal, hepatic, and hematologic functions are required, along with signed informed consent.

Age and Sex: 1. Participants age >=18 years (or the minimum country-specific age of consent if >18).Male participants and female participants of childbearing potential must agree to use methods of contraception as described in Section 5.3.1 and in Section 10.10 for applicable country-specific requirements.Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.Type of Participant and Disease Characteristics: 2. Participants who are willing and able to comply with all scheduled visits, treatment plan, required concomitant medication(s), laboratory tests, lifestyle considerations, and other study procedures. 3. Prior diagnosis of MM as defined according to IMWG criteria. 4. Measurable disease based on IMWG criteria as defined by at least 1 of the following: * Serum M-protein >=0.5 g/dL; * Urinary M-protein excretion >= 200 mg/24 hours; * Serum immunoglobulin FLC $\ge$10 mg/dL ($\ge$100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65). * For Parts 2 and 3, measurable disease eligibility is to be based on results from the central laboratory. 5. Prior anti-MM therapy (refer to Appendix 15 for quantitating number of prior lines of therapy): * Part 1: At least 3 prior lines of anti-MM therapy including treatment with lenalidomide and a PI. * Part 2: At least 1, but not more than 3, prior lines of anti-MM therapy including treatment with lenalidomide and a PI. A response of MR or better must have been achieved with any prior anti-MM therapy based on investigator assessment using IMWG criteria. * Part 3 Arm D: At least 1, but not more than 3, prior lines of anti-MM therapy including treatment with lenalidomide and an anti-CD38-directed therapy. A response of PR or better must have been achieved with any prior anti-MM therapy. * Part 3 Arm E: At least 1, but not more than 3, prior lines of anti-MM therapy including treatment with lenalidomide. A response of PR or better must have been achieved with any prior anti-MM therapy. 6. ECOG performance status $\le$2. 7. Left ventricular ejection fraction (LVEF) $\ge$40% as determined by a MUGA scan or ECHO. 8. Adequate hepatic function characterized by: * Total bilirubin $\le$1.5 x ULN ($\le$3 $\times$ ULN if documented Gilbert’s syndrome); * AST $\le$2.5 x ULN and ALT $\le$2.5 x ULN. 9. Adequate renal function defined as: eGFR $\ge$30 mL/min/1.73 $m^2$ or estimated creatinine clearance $\ge$30 mL/min. 10. Adequate BM function characterized by: * ANC $\ge$1.0 $\times$ $10^9$/L (GCSF permitted if completed $\ge$7 days prior to eligibility sample collection and $\ge$7 days prior to planned start of dosing). * Platelet count $\ge$75,000/µL if <50% of BM nucleated cells are plasma cells, or $\ge$50,000/µL if $\ge$50% of BM nucleated cells are plasma cells (transfusion support permitted if completed $\ge$7 days prior to eligibility sample collection and $\ge$7 days prior to start of dosing). * Hemoglobin $\ge$8 g/dL (transfusion support permitted if completed $\ge$14 days prior to eligibility sample collection and $\ge$14 days prior to start of dosing). * NOTE: Hematologic parameters must also be met on C1D1 prior to treatment. 11. Corrected serum calcium $\le$14 mg/dL ($\le$3.5 mmol/L), or free ionized calcium $\le$6.5 mg/dL ($\le$1.6 mmol/L). 12. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade $\le$1.+4Informed Consent: 13. Capable of giving signed informed consent, which includes compliance with requirements and restrictions in the ICD and protocol.

Excludes smoldering MM, CNS involvement, recent transplants, significant heart disease, active infections (HBV/HCV/HIV/COVID), and other cancers. Prior BCMA/CD3 therapies, severe neuropathy, pregnancy, recent surgery, or live vaccines are also prohibited.

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