Status:
ACTIVE_NOT_RECRUITING
Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
Lead Sponsor:
Allogene Therapeutics
Conditions:
Relapsed/Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04093596
Start Date
September 23 2019
End Date
September 1 2027
Last Update
August 14 2023
Active Locations (11)
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1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
City of Hope
Duarte, California, United States, 91010
3
Stanford Cancer Institute
Palo Alto, California, United States, 94305
4
Sarah Cannon/Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218