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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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
To evaluate the blood drug concentration
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