Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)

Inclusion Criteria:

• Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurabledisease (serum, urine, or free light chain [FLC]) per International Myeloma WorkingGroup (IMWG) criteria

• At least 3 prior lines of MM therapy, including a proteasome inhibitor,immunomodulatory agent, and anti-CD38 antibody (unless contraindicated), andrefractory to the last treatment line.

• Eastern Cooperative Oncology Group (ECOG) 0 or 1

• Absence of donor (product)-specific anti-HLA antibodies

• Adequate hematologic, renal, hepatic, pulmonary, and cardiac function

Exclusion Criteria:

• Current or history of Central Nervous System (CNS) involvement of myeloma or plasmacell leukemia

• Clinically significant CNS disorder

• Current or history of thyroid disorder

• Autologous stem cell transplant within the last 6 weeks, or any allogeneic stem celltransplant

• Prior treatment with anti-BCMA therapy, any gene therapy, any genetically modifiedcell therapy, or adoptive T cell therapy

• History of HIV infection or acute or chronic active hepatitis B or C infection

• Patients unwilling to participate in an extended safety monitoring period

Additional Exclusion Criteria for Nirogacestat plus ALLO-715 Cohorts

• Inability to swallow tablets

• Subject has known malabsorption syndrome or preexisting gastrointestinal conditionsthat may impair absorption of nirogacestat

• Use of strong/moderate CYP3A4 inhibitors, and strong CYP3A4 inducers within 14 daysbefore starting nirogacestat.

• Use of concomitant medications that are known to prolong the QT/QTcF interval