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

Overview

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.

SparkCures ID 921
Trial Phase Phase 1
Enrollment 64 Patients
Treatments
Trial Sponsors
  • Kite, A Gilead Company
NCT Identifier

NCT03318861

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.

Key Inclusion Criteria:

  1. 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.
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  3. 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

Key Exclusion Criteria:

  1. Plasma cell leukemia
  2. Non-secretory multiple myeloma
  3. History of CNS involvement by MM
  4. Prior CAR therapy or other genetically modified T cells
  5. Inadequate washout from prior therapy
  6. Autologous stem cell transplant within 6 weeks before enrollment or any history of allogenic transplant
  7. History of active autoimmune disease
  8. History of deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within 6 months before enrollment
  9. Recent history of other (non multiple myeloma) cancer
  10. Active viral, fungal, bacterial or other infection

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

View Centers

Trial Links

Read the latest news and updates on this trial.

Gilead drops anti-BCMA CAR-T from Kite, takes $820M charge

February 05, 2019

Buried in among Gilead’s fourth-quarter results statement is a line revealing it has abandoned an anti-BCMA cell therapy for multiple myeloma, part of its $12 billion acquisition of Kite Pharma.

Read more