Study Details

PROTOCOL SUMMARY

The primary objective of the study is to evaluate the safety and tolerability of KITE-585, an autologous engineered chimeric antigen receptor (CAR) T-cell product targeting a protein commonly found on myeloma cells called B-cell maturation antigen (BCMA), as measured by the incidence of dose-limiting toxicities (DLTs). Participants will be given a 3 day course of conditioning chemotherapy followed by a single infusion of KITE-585.

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

Medical Condition

Relapsed/Refractory Multiple Myeloma

Gender

N/A

Date

October 2017 - December 2018

Study Type

Interventional

Study Phase

Phase 1

Product

KITE-585, Cyclophosphamide, Fludarabine

Eligibility Information

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
Prior 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply

Locations

Locations (9)

David Geffen School of Medicine at UCLA

Los Angeles, California, United States, 90095

H. Lee Moffitt Cancer Center

Tampa, Florida, United States, 33612

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States, 30322

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02114

Mayo Clinic

Rochester, Minnesota, United States, 55905

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma

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