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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03318861
Recruitment Status : Active, not recruiting
First Posted : October 24, 2017
Last Update Posted : May 30, 2019
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Genetic: Autologous genetically modified anti-BCMA CAR transduced T cells (KITE-585) Drug: Cyclophosphamide Drug: Fludarabine Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single Arm, Dose-Escalation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Multicenter Study of KITE-585, an Autologous Anti-BCMA CAR T-Cell Therapy, in Subjects With Relapsed/Refractory Multiple Myeloma
Actual Study Start Date : October 31, 2017
Actual Primary Completion Date : May 9, 2019
Estimated Study Completion Date : November 2033

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Relapsed/Refractory Multiple 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

Primary Outcome Measures :
  1. Incidence of adverse events defined as DLTs [ Time Frame: Up to 2 years ]
    Determine maximum tolerated dose

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: Up to 2 years ]
    Objective response rate (partial response [PR] + very good PR (VGPR) + complete response [CR] + stringent CR [sCR]) according to International Myeloma Working Group (IMWG) Consensus Panel 1

  2. Duration of response (DOR) [ Time Frame: Up to 15 years ]
    DOR is defined as the time from the first objective response to disease progression per IMWG Consensus Panel 1 Criteria.

  3. Progression free survival (PFS) [ Time Frame: Up to 15 years ]
    PFS defined as the time from KITE-585 infusion to the date of disease progression per the IMWG Consensus Panel 1 Criteria by study investigators or death from any cause.

  4. Incidence of adverse events (AE) [ Time Frame: Up to 15 years ]
    The frequency of any AEs that occurred during study participation.

  5. Clinically significant changes in lab values [ Time Frame: Up to 15 years ]
    The occurrence of any changes in lab values deemed to be clinically significant during study participation.

  6. Overall Survival [ Time Frame: Up to 15 years ]
    OS is defined as the time from KITE-585 infusion to the date of death.

  7. Time to next treatment (TTNT) [ Time Frame: Up to 15 years ]
    TTNT is defined as the length of time between the date of KITE-585 infusion to the date of initiation of the next therapy that was started after documented disease progression.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03318861

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United States, California
University of California Los Angeles
Los Angeles, California, United States, 90024
United States, Florida
H Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago Medicine
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Kite, A Gilead Company
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Study Director: Kite Study Director Kite, A Gilead Company

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Responsible Party: Kite, A Gilead Company Identifier: NCT03318861     History of Changes
Other Study ID Numbers: KITE-585-501
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic