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

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Overview

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.

SparkCures ID 1031
Trial Phase Phase 1
Enrollment 132 Patients
Treatments
Tags
Trial Sponsors
  • Allogene Therapeutics
NCT Identifier

NCT04093596

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Arizona
Banner - University Medical Center Tucson Banner Health
California
Stanford Cancer Institute
Colorado
Massachusetts
Massachusetts General Hospital
Minnesota
Mayo Clinic (Rochester)
Mayo Clinic (Rochester)

Rochester, MN

New York
Memorial Sloan Kettering Cancer Center
Ohio
Cleveland Clinic Taussig Cancer Institute
Tennessee
Vanderbilt-Ingram Cancer Center Henry-Joyce Cancer Clinic
Texas
St. David's South Austin Medical Center
Methodist Hospital
Methodist Hospital

San Antonio, TX

Wisconsin
Medical College of Wisconsin Froedtert Hospital

Published Results

Off-the-Shelf CAR Therapy Shows Early Promise in Multiple Myeloma

December 05, 2020

ALLO-715, an off-the-shelf chimeric antigen receptor (CAR) T-cell therapy that targets B-cell maturation antigen (BCMA), elicited responses in heavily pretreated patients with relapsed/refractory multiple myeloma in early findings from a first-in-human study presented at the 2020 ASH Meeting.

The therapy generated responses in 6 of 10 patients (60%), including a very good partial-plus response (VGPR+) in 4 patients (40%), who were treated with ALLO-715 at a dose of 320 x 106 CAR cells plus a lymphodepleting regimen that included ALLO-647, an anti-CD52 monoclonal antibody, during the ongoing phase 1 UNIVERSAL study (NCT04093596).

Resources

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