Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
Trial ID or NCT#
NCT04093596
Status
NOT RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Surbhi Sidana, MD
Blood and marrow transplant specialist,
Hematologist-Oncologist
Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Contact us to find out if this trial is right for you.
Contact
Mani Gupta
650-723-0501
View on ClinicalTrials.gov
