Clinical Trials /

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

NCT04093596

Description:

The purpose of the UNIVERSAL study is to assess the safety, efficacy, cell kinetics, and immunogenicity of ALLO-715 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.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
  • 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 in Subjects With Relapsed/Refractory Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: ALLO-715-101
  • NCT ID: NCT04093596

Conditions

  • Relapsed/Refractory Multiple Myeloma

Interventions

DrugSynonymsArms
ALLO-647ALLO-647, ALLO-715
FludarabineALLO-647, ALLO-715
CyclophosphamideALLO-647, ALLO-715

Purpose

The purpose of the UNIVERSAL study is to assess the safety, efficacy, cell kinetics, and immunogenicity of ALLO-715 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.

Trial Arms

NameTypeDescriptionInterventions
ALLO-647, ALLO-715Experimental
  • ALLO-647
  • Fludarabine
  • Cyclophosphamide

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-715
Time Frame:28 Days
Safety Issue:
Description:Dose limiting toxicities are defined as ALLO-715-related adverse events with onset within 28 days following infusion of ALLO-715.

Secondary Outcome Measures

Measure:Proportion of subjects experiencing Dose Limiting Toxicities with ALLO-647 in combination with fludarabine and/or cyclophosphamide, or ALLO-647 alone, prior to ALLO-715
Time Frame:33 days
Safety Issue:
Description:Dose limiting toxicity is defined as ALLO-647-related adverse events with onset within 33 days following first infusion of ALLO-647.
Measure:Cellular kinetics of ALLO-715
Time Frame:up to 24 months
Safety Issue:
Description:Levels of anti-BCMA CAR T cells in blood
Measure:Pharmacokinetics of ALLO-647
Time Frame:up to 24 months
Safety Issue:
Description:Serum concentration levels of ALLO-647
Measure:Incidence of immunogenicity against ALLO-715 and ALLO-647
Time Frame:up to 24 months
Safety Issue:
Description:
Measure:Immune monitoring after lymphodepletion regimen
Time Frame:up to 24 months
Safety Issue:
Description:Detection of the following circulating cells: T cell subset, B lymphocytes, and NK cells
Measure:Anti-tumor activity of ALLO-715
Time Frame:up to 24 months
Safety Issue:
Description:overall response rate
Measure:Anti-tumor activity of ALLO-715
Time Frame:up to 24 months
Safety Issue:
Description:time to response rate
Measure:Anti-tumor activity of ALLO-715
Time Frame:up to 24 months
Safety Issue:
Description:duration of response
Measure:Anti-tumor activity of ALLO-715
Time Frame:up to 24 months
Safety Issue:
Description:progression-free survival
Measure:Anti-tumor activity of ALLO-715
Time Frame:up to 24 months
Safety Issue:
Description:overall survival
Measure:Anti-tumor activity of ALLO-715
Time Frame:up to 24 months
Safety Issue:
Description:minimal residual disease

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Allogene Therapeutics

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