The goal of this clinical trial is to evaluate the safety, tolerability, and recommended Phase 2 Dose (RP2D) of KLN-1010 in patients with relapsed or refractory multiple myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Given at specified dose one time
City of Hope
Duarte, California, United States
RECRUITINGStanford University
Palo Alto, California, United States
RECRUITINGUCSF
San Francisco, California, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGEmory University Hospital
Atlanta, Georgia, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGJohn Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, United States
RECRUITINGProvidence Portland Medical Center
Portland, Oregon, United States
RECRUITINGThe Royal Prince Alfred
Camperdown, New South Wales, Australia
RECRUITINGPeter MacCallum Cancer Centre
Melbourne, Victoria, Australia
RECRUITING...and 1 more locations
Incidence and severity of treatment-emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs), and/or establish the recommended Phase 2 Dose
All adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) or American Society for Transplantation and Cell Therapy (ASTCT) criteria
Time frame: Up to 15 years from dosing of KLN-1010
Pharmacokinetics of KLN-1010 after dosing.
Peak of virus vector genomes (Cmax of lentivirus) in blood.
Time frame: Up to two years after dosing with study drug.
Pharmacokinetics of KLN-1010 (Tmax).
Measurement of time to the highest amount of viral vector in the blood.
Time frame: Up to two years after infusion with study drug.
Pharmacokinetics of KLN-1010 Area Under the Curve (AUC)
Measurement of the amount of viral vector (AUC of lentivirus) in blood over time.
Time frame: Up to two years after infusion with study drug.
Pharmacokinetics of CAR-T cells generated.
The presence and number of CAR-T (Cmax) cells present in blood.
Time frame: Up to two years after infusion with study drug.
Pharmacokinetics of CAR-T cells generated (Tmax).
Measurement of time to the highest amount of CAR-T cells in the blood.
Time frame: Up to two years after infusion with study drug.
Pharmacokinetics of CAR-T cells generated Area Under the Curve (AUC)
Measurement of the amount of CAR-T cell DNA in blood and bone marrow over time.
Time frame: Up to two years after infusion with study drug.
Assessment of Multiple Myeloma
Participants will have multiple myeloma assessed according to the International Myeloma Working Group (IMWG) response criteria.
Time frame: From dosing until disease progression or up to 15 years from receiving study drug, whichever happens first.
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