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

• Status: Active, not recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the UNIVERSAL study is to assess the safety, efficacy, cell kinetics, and immunogenicity of ALLO-715 with or without Nirogacestat 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allogene Therapeutics
• Treatments: Allopurinol; Cyclophosphamide; Fludarabine

Criteria

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