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

  • STATUS
    Recruiting
  • End date
    Nov 28, 2024
  • participants needed
    90
  • sponsor
    Allogene Therapeutics
Updated on 28 January 2021

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.

Details
Condition Relapsed Refractory Multiple Myeloma
Treatment cyclophosphamide, Fludarabine, ALLO-647, ALLO-715, Nirogacestat
Clinical Study IdentifierNCT04093596
SponsorAllogene Therapeutics
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Relapsed Refractory Multiple Myeloma?
Do you have any of these conditions: Do you have Relapsed Refractory Multiple Myeloma??
Do you have any of these conditions: Do you have Relapsed Refractory Multiple Myeloma??
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
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