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).
Adults (≥18 years) with confirmed T-cell lymphoma subtypes: PTCL (including nodal T-follicular helper cell lymphoma, ALCL, PTCL NOS) for Parts 1 and 2; CTCL (mycosis fungoides or Sézary syndrome, stages IIB-IV) for Parts 1 and 2, with specific disease involvement criteria in Part 2.
PTCL participants must have relapsed/refractory/intolerant to ≥1 systemic therapy; CD30+ PTCL must have prior brentuximab vedotin treatment or intolerance, and/or ALK-positive ALCL participants should have previously received crizotinib if indicated (crizotinib administration is applicable to US sites only). CTCL participants must have relapsed/refractory/intolerant to ≥2 systemic therapies.
Availability of tumor tissue (current or archival) is required.
Measurable disease required: nodal/extranodal lesions for PTCL and assessable skin disease for CTCL.
Recent autologous or allogeneic transplant within 120 days before treatment; active GVHD or ongoing immunosuppression after allogeneic transplant; prior HSCT and with active VOD/SOS
Pregnant or breastfeeding females, or those intending pregnancy.
History of HIV, HBV, or HCV infections generally excluded, except for controlled or resolved cases as defined.
Uncontrolled infections requiring antibiotics, antivirals, or antifungals at screening through treatment start.
Sequential
KK2223
DrugIntravenous 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)
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)
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)
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)
Mean Blood Drug Concentration
The mean drug concentration in the blood
To evaluate the immunogenicity of KK2223.
Incidence of Anti drug antibodies (ADA) in blood
To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).
% in Overall Response Rate (ORR)
To evaluate the preliminary anti-tumor activity of KK2223 (Investigator assessed).
% in Compartment Response (if applicable)
Click on the lead sponsor to view all of their trials.
