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A Phase 1 Multicenter Study of KITE-585, an Autologous Anti-BCMA CAR T-Cell Therapy, in Subjects with Relapsed/ Refractory Multiple Myeloma
Protocol Number:
Phase I
Ivan Borrello
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this study is to see how safe and how tolerable KITE-585 (the study drug) is.
Inclusion:- Measurable, progressed multiple myeloma- 18+ years old- good physical health- adequate measurable bone marrow, kidney, liver, pulmonary, and heart functioning- not pregnant Exclusion- over 5% of atypical plasma cells- non-secretory multiple myeloma- active or prior history of central nervous system or meningeal involvement- prior BCMA- targeted or CAR therapy- treatment with non-immune directed systemic therapy within 2 weeks - treatment with immune directed systemic therapy close to leukapheresis- Auto- stem cell transplant within 6 weeks - Allo stem cell transplant- Treatment of corticosteroids within a week of leukapheresis- Ongoing toxicities from prior therapy- other malignancies, hypersensitivity reaction, uncontrolled infections, HIV, hepatitis B or C virus, tuberculosis, autoimmune diseases, cardiac amyloid deposition, cardiac disease- presence of line or drain- traumatic injury within 3 weeks prior to conditioning therapy or surgery within 4 weeks of conditioning therapy- requirement of urgent therapy due to oncologic emergency- reason to require systemic anticoagulation within 6 months prior to enrollment- pregnant or breastfeeding woman- individuals not willing to practice birth control- psychiatric condition- inability to complete all protocol required study visits or procedures
After screening into the trial, participants will be leukapheresed (white blood cells collection) to make KITE-585. After leukapheresis, participants have the option of bridging therapy before starting conditioning chemotherapy. KITE-585 will be infused by IV and followed regularly (requiring doctors visit).
Last Update
03/05/2019 05:03 AM