Status:
TERMINATED
Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
Kite, A Gilead Company
Conditions:
Relapsed/Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
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 an...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- 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
Key Trial Info
Start Date :
October 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2022
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03318861
Start Date
October 20 2017
End Date
September 16 2022
Last Update
October 19 2023
Active Locations (9)
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1
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
2
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
4
University of Chicago Medical Center
Chicago, Illinois, United States, 60637