©2024 Stanford Medicine
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
Professor of Medicine (Hematology)
Surbhi Sidana, MD
Associate 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