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

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Overview

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.

SparkCures ID 1031
Trial Phase Phase 1
Enrollment 132 Patients
Treatments
Tags
Trial Sponsors
  • Allogene Therapeutics
NCT Identifier

NCT04093596

CLOSED

This trial is active but is no longer accepting patients.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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

US Trial Locations

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