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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- genetic: ALLO-715
- biological: ALLO-647
- drug: Fludarabine
- drug: Cyclophosphamide
- drug: Nirogacestat
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mani Gupta
650-723-0501
Not Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.
