Skip to main content

Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

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.
Multiple Myeloma, Phase I
Phase I
Adults
Chemotherapy - cytotoxic, Gene Therapy, Mol. targeted/Immunotherapy/Biologics
ALLO-647, ALLO-715, Cyclophosphamide, Fludarabine (Fludara), PF-03084014 (Nirogacestat)
Oluwole, Olalekan
National
Vanderbilt University
02-11-2020
Treatment
VICCCTTP1955
NCT04093596

Eligibility

18 Years
BOTH
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

To learn more about any of our clinical
trials, call 1-800-811-8480 or complete
the online Self-Referral Form here: