Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
Trial ID or NCT#
The purpose of the UNIVERSAL study is to assess the safety, efficacy, cell kinetics, and immunogenicity of ALLO-715 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen of ALLO-647 in combination with fludarabine and/or cyclophosphamide, or ALLO-647 alone.
A Single-Arm, Open-Label, Phase 1 Study of the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-715 to Evaluate an Anti-BCMA Allogeneic CAR T Cell Therapy in Subjects With Relapsed/Refractory Multiple Myeloma
- - 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
- - 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
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