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 measurable
   disease (serum, urine, or free light chain [FLC]) per International Myeloma Working
   Group (IMWG) criteria

   - At least 3 prior lines of MM therapy, including a proteasome inhibitor,
   immunomodulatory agent, and anti-CD38 antibody (unless contraindicated), and
   refractory 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 plasma
   cell leukemia

   - Clinically significant CNS disorder

   - Current or history of thyroid disorder

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

   - Prior treatment with anti-BCMA therapy, any gene therapy, any genetically modified
   cell 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 conditions
   that may impair absorption of nirogacestat

   - Use of strong/moderate CYP3A4 inhibitors, and strong CYP3A4 inducers within 14 days
   before starting nirogacestat.

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