Is positive for cytomegalovirus (CMV) by PCR, CMV immunoglobulin M (IgM) antibody, or Coronavirus disease 2019 (COVID-19) by PCR.
10. Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina,
or a history of myocardial infarction or significant arrhythmia.
11. Has any psychiatric or medical disorder that would preclude safe participation in
and/or adherence to the protocol.
12. Has received prior allogeneic cellular therapy or gene therapy. 13. Has received anti-cancer medications within 2 weeks of the time of initiating
conditioning LD therapy.
14. Has received monoclonal antibody therapy within 4 weeks of initiating conditioning LD
therapy.
15. Has received immunosuppressive medications within 2 weeks of the time of
administration of P-BCMA-ALLO1, and/or expected to require them while on study.
16. Has received systemic corticosteroid therapy within 1 week or 5 half-lives (whichever
is shorter) of the administration of P-BCMA-ALLO1 or is expected to require it during the course of the study.
17. Has CNS metastases or symptomatic CNS involvement of their myeloma. 18. Has a history of severe immediate hypersensitivity reaction to any of the agents used
in this study.
19. Has a history of having undergone allogeneic stem cell transplantation, or any other
allogeneic or xenogeneic transplant, or has undergone autologous transplantation within 90 days.
20. Arms R, RS, RP1, RP1.5 and RP2 Only: a) Has received a live vaccine within the last 28
days of the first administration of agents used in Arm R or RS, b) Has any known hypersensitivity or severe reactions or toxicity to agents used in Arms R or RS.