A Study Evaluating the Safety and Efficacy of KITE-585 in Subjects With Relapsed / Refractory Multiple Myeloma

Status: Active

Description

To evaluate the safety and tolerability of KITE-585, an autologous engineered CAR T-cell product targeting a protein commonly found on myeloma cells called BCMA. Patients will be given a 3 day course of chemotherapy followed by a single infusion of KITE-585.

Eligibility Criteria

Inclusion Criteria

  • Measurable relapsed or refractory myeloma as defined by the International Myeloma Working Group (IMWG) Consensus Criteria following treatment with at least 3 lines of therapy including with both a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or progressive myeloma that is refractory to a regimen containing both a PI and an IMiD.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as:
  • Absolute neutrophil count (ANC) ≥ 1,000/µL
  • Platelet count ≥ 75,000/µL
  • Absolute lymphocyte count ≥ 100/µL
  • Creatinine clearance above limits set in the protocol for each cohort
  • Normal cardiac function as assessed by electrocardiogram (ECG) and echocardiogram
  • Baseline oxygen saturation > 92% on room air and no clinically significant pleural effusion

Exclusion Criteria

  • Plasma cell leukemia
  • Non-secretory multiple myeloma
  • History of Central nervous system (CNS) involvement by multiple myeloma (MM)
  • Prior chimeric antigen receptor (CAR) therapy or other genetically modified T cells
  • Inadequate washout from prior therapy
  • Autologous stem cell transplant within 6 weeks before enrollment or any history of allogenic transplant
  • History of active autoimmune disease
  • History of deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within 6 months before enrollment
  • Recent history of other (non multiple myeloma) cancer
  • Active viral, fungal, bacterial or other infection

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Name Not Available

Florida

Jacksonville
Mayo Clinic in Florida
Status: Temporarily closed to accrual
Name Not Available
Tampa
Moffitt Cancer Center
Status: Active
Contact: Frederick Lundry Locke
Phone: 800-456-7121
Email: canceranswers@moffitt.org

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Name Not Available

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Name Not Available

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Active
Name Not Available
Massachusetts General Hospital Cancer Center
Status: Active
Contact: Noopur S. Raje
Phone: 617-724-4000
Email: NRAJE@mgh.harvard.edu

Minnesota

Rochester
Mayo Clinic
Status: Temporarily closed to accrual
Name Not Available

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Temporarily closed to accrual
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Objectives and Outline

Participants with relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, ECG and echocardiogram of the heart, brain MRI, and blood draws. Eligible participants have white blood cells collected by apheresis. These cells are genetically modified to make the experimental treatment KITE-585. Participants receive chemotherapy prior to the KITE-585 infusion. After the KITE-585 infusion, participants will be followed for side effects and effect of KITE-585 on their myeloma. Study procedures may be performed while hospitalized and/or in the outpatient setting.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Kite, A Gilead Company

Trial IDs

Primary ID KITE-585-501
Secondary IDs NCI-2017-02053
Clinicaltrials.gov ID NCT03318861