Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
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.
Multiple Myeloma,
Phase I
Phase I
Adults
Chemotherapy - cytotoxic,
Gene Therapy,
Mol. targeted/Immunotherapy/Biologics
ALLO-647,
ALLO-715,
Cyclophosphamide,
Fludarabine (Fludara),
PF-03084014 (Nirogacestat)
Oluwole, Olalekan
National
Vanderbilt University
02-11-2020
Treatment
VICCCTTP1955
NCT04093596
Eligibility
18 Years
BOTH
NO
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
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
