Clinical Trials

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.

Eligibility last updated 3/24/22. Questions regarding updates should be directed to the study team contact.