The purpose of this study is to determine the safety, tolerability, PK and pharmacodynamics of KK2223 in adult participants with relapsed or refractory peripheral T cell lymphoma (PTCL) or cutaneous T cell lymphoma (CTCL).
This is a Phase 1, multicenter, open-label, non randomized study in participants with relapsed or refractory PTCL or CTCL. This study consists of Part 1 (dose-escalation) and Part 2 (backfill). The purpose of this study is to determine the safety, tolerability, PK and pharmacodynamics of K2223 in r/r T-cell NHL (PTCL or CTCL)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Intravenous infusion
Assess the incidence of treatment-emergent adverse events and determine the maximum tolerated dose (MTD) of KK2223 in patients with relapsed or refractory peripheral or cutaneous T cell lymphoma (PTCL/CTCL).
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (all 72 potentially treated subjects)
Time frame: Through study completion, an average of 1.5 years
Assess the incidence of treatment-emergent adverse events and determine the maximum tolerated dose (MTD) of KK2223 in patients with relapsed or refractory peripheral or cutaneous T cell lymphoma (PTCL/CTCL).
Vital signs (mmHg in Systolic/Diastolic blood pressure)
Time frame: Through study completion, an average of 1.5 years
Assess the incidence of treatment-emergent adverse events and determine the maximum tolerated dose (MTD) of KK2223 in patients with relapsed or refractory peripheral or cutaneous T cell lymphoma (PTCL/CTCL).
Pulse rate (beats/min)
Time frame: Through study completion, an average of 1.5 years
Assess the incidence of treatment-emergent adverse events and determine the maximum tolerated dose (MTD) of KK2223 in patients with relapsed or refractory peripheral or cutaneous T cell lymphoma (PTCL/CTCL).
Respiratory Rate (breath/min)
Time frame: Through study completion, an average of 1.5 years
Assess the incidence of treatment-emergent adverse events and determine the maximum tolerated dose (MTD) of KK2223 in patients with relapsed or refractory peripheral or cutaneous T cell lymphoma (PTCL/CTCL).
Temperature (°Celcius)
Time frame: Through study completion, an average of 1.5 years
Assess the incidence of treatment-emergent adverse events and determine the maximum tolerated dose (MTD) of KK2223 in patients with relapsed or refractory peripheral or cutaneous T cell lymphoma (PTCL/CTCL).
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City of Hope
Duarte, California, United States
NOT_YET_RECRUITINGUniversity of California, Irvine Medical Center - Hematology/Oncology
Orange, California, United States
NOT_YET_RECRUITINGStanford University School of Medicine
Stanford, California, United States
RECRUITINGMoffit Cancer Center
Tampa, Florida, United States
NOT_YET_RECRUITINGEmory University Medical Center
Atlanta, Georgia, United States
NOT_YET_RECRUITINGUniversity of Iowa Health
Iowa City, Iowa, United States
NOT_YET_RECRUITINGBeth Israel Deaconess Medical Center - Research
Boston, Massachusetts, United States
NOT_YET_RECRUITINGWashington University School of Medicine - Oncology Hospital - Public
St Louis, Missouri, United States
RECRUITINGHackensack University Medical Center - John Theurer Cancer C - Lymphoma Division
Hackensack, New Jersey, United States
NOT_YET_RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITING...and 12 more locations
ECG parameters (PR interval, QRS interval, QT interval, QTc interval)
Time frame: Through study completion, an average of 1.5 years
Assess the incidence of treatment-emergent adverse events and determine the maximum tolerated dose (MTD) of KK2223 in patients with relapsed or refractory peripheral or cutaneous T cell lymphoma (PTCL/CTCL).
Number of participants with dose-limiting toxicities (DLTs) in Part 1 only (at most 27 participants) and assess maximum tolerated dose (MTD)
Time frame: Through study completion, an average of 1.5 years
Mean Blood Drug Concentration
The mean drug concentration in the blood
Time frame: Through study completion, an average of 1.5 years
To evaluate the immunogenicity of KK2223.
Incidence of Anti drug antibodies (ADA) in blood
Time frame: Through study completion, an average of 1.5 years
To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).
% in Overall Response Rate (ORR)
Time frame: Through study completion, an average of 1.5 years
To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).
% in Compartment Response (if applicable)
Time frame: Through study completion, an average of 1.5 years
To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).
Time unit (week/month) in Duration of Response (DOR)
Time frame: Through study completion, an average of 1.5 years
To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).
Time unit (week/month) in Time To Next Treatment (TTNT) will be evaluated
Time frame: Through study completion, an average of 1.5 years
To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).
Time unit (week/month) in Time To Response (TTR)
Time frame: Through study completion, an average of 1.5 years
Pharmacokinetic Parameter Maximum Blood Concentration (Cmax)
The maximum drug concentration
Time frame: Through study completion, an average of 1.5 years
Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUC)
A measure of the overall drug exposure over time
Time frame: Through study completion, an average of 1.5 years
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)
The time taken to reach the maximum drug concentration
Time frame: Through study completion, an average of 1.5 years
Pharmacokinetic Parameter Terminal Half-Life (Thalf)
The time required for the drug concentration to decrease by 50%
Time frame: Through study completion, an average of 1.5 years
Pharmacokinetic Parameter Clearance (CL)
Rate of drug elimination from the body
Time frame: Through study completion, an average of 1.5 years
Pharmacokinetic Parameter Volume of Distribution at Steady State (Vss)
Theoretical volume of distribution at steady state and reflects the extent of drug istribution into tissues
Time frame: Through study completion, an average of 1.5 years