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Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
Not Recruiting
Trial ID: NCT04093596
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.
Official Title
A Single-Arm, Open-Label, Phase 1 Study of the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-715 to Evaluate an Anti-BCMA Allogeneic CAR T Cell Therapy With or Without Nirogacestat in Subjects With Relapsed/Refractory Multiple Myeloma
Stanford Investigator(s)
Michaela Liedtke
Associate Professor of Medicine (Hematology)
Surbhi Sidana, MD
Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
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
Intervention(s):
genetic: ALLO-715
biological: ALLO-647
drug: Fludarabine
drug: Cyclophosphamide
drug: Nirogacestat
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mani Gupta
650-723-0501