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

Purpose

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.

Condition

  • Multiple Myeloma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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:
  4. Absolute neutrophil count (ANC) ≥ 1,000/µL
  5. Platelet count ≥ 75,000/µL
  6. Absolute lymphocyte count ≥ 100/µL
  7. Creatinine clearance above limits set in the protocol for each cohort
  8. Normal cardiac function as assessed by electrocardiogram (ECG) and echocardiogram
  9. Baseline oxygen saturation > 92% on room air and no clinically significant pleural effusion

Exclusion Criteria

  1. Plasma cell leukemia
  2. Non-secretory multiple myeloma
  3. History of Central nervous system (CNS) involvement by multiple myeloma (MM)
  4. Prior chimeric antigen receptor (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

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Study Design

Phase
Phase 1
Study Type
Interventional
Intervention Model
Single Group Assignment
Intervention Model Description
Single Arm, Dose-Escalation
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Relapsed/Refractory Muliple Myeloma Subjects
Phase 1 dose-escalation
  • Genetic: Autologous genetically modified anti-BCMA CAR transduced T cells (KITE-585)
    A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells (KITE-585)
  • Drug: Cyclophosphamide
    Administered intravenously
  • Drug: Fludarabine
    Administered intravenously

More Details

NCT ID
NCT03318861
Status
Active, not recruiting
Sponsor
Kite, A Gilead Company

Study Contact

Detailed Description

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.