Trial Search Results

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

The main goals of this study are to test the safety of ALLO-715 in combination with ALLO-647 and to determine the safe dose of ALLO-715 following lymphodepletion with ALLO-647. The study will also explore the safety of ALLO-647 in combination with one or two other treatments used to prepare you to receive ALLO-715. Another goal of the study is to assess how well ALLO-715 works on subjects With Relapsed/RefractoryMultiple Myeloma. The study is made up of two parts. The first part is called dose escalation and the second part is called dose expansion. In the dose escalation phase, the purpose of study is to test different doses of ALLO-715, following lymphodepletion regimens using different combinations of medications including ALLO-647 to determine safety and which is most effective. In the dose expansion phase of the study, an ALLO-715 dose level andlymphodepleting regimen will be chosen, and additional patients treated with that dose.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Allogene Therapeutics

Stanford Investigator(s):

Intervention(s):

  • Genetic: ALLO-715
  • Biological: ALLO-647
  • Drug: Fludarabine
  • Drug: Cyclophosphamide

Phase:

Phase 1

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

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mani Gupta
650-723-0501
Recruiting