Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ALLO-647, ALLO-715, Nirogacestat
  • Genetic: ALLO-715
    ALLO-715 is an allogeneic CAR T cell therapy targeting BCMA
  • Biological: ALLO-647
    ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
  • Drug: Fludarabine
    Chemotherapy for lymphodepletion
  • Drug: Cyclophosphamide
    Chemotherapy for lymphodepletion
  • Drug: Nirogacestat
    a small molecule, selective, reversible, noncompetitive inhibitor of γsecretase (GSI) that increases BCMA target density on the surface of multiple myeloma cells.

More Details

Status
Active, not recruiting
Sponsor
Allogene Therapeutics

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.