Skip to main content

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

Trial Status: Active

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.

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

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE

New York

New York
Icahn School of Medicine at Mount Sinai
Status: ACTIVE
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Allogene Therapeutics

  • Primary ID ALLO-715-101
  • Secondary IDs NCI-2019-07965
  • Clinicaltrials.gov ID NCT04093596