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

Completed · Phase 1

Conditions studied: Relapsed/Refractory Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT04093596

Run by

Allogene Therapeutics

People needed

73

Starts

2019-09-23

Expected to finish

2025-01-27

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• City of Hope — Duarte, California, United States
• Stanford Cancer Institute — Palo Alto, California, United States
• Sarah Cannon/Colorado Blood Cancer Institute — Denver, Colorado, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• St. David's South Austin Medical Center — Austin, Texas, United States
• Texas Transplant Institute — San Antonio, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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