This is a Phase 1-2, randomized, multicenter, open label study of PLM60 administered via intravenous (IV) infusion in 28 day treatment cycles to adult participants with relapsed or refractory Peripheral T Cell Lymphoma (PTCL).
The study is designed to identify and characterize the safety, tolerability, efficacy, and the PK profile of PLM60 in patients with relapsed or refractory PTCL. Phase 1 will explore multiple dose levels and select a single dose level in Phase 2 to more effectively assess efficacy in the PTCL population. It is anticipated that up to approximately 30 participants will be enrolled during Phase 1. The actual number enrolled, however, will depend on the number of dose-limiting toxicity (DLT)-evaluable participants that complete the first cycle of therapy. Phase 2 will enroll up to 34 participants at the RP2D, some of whom will have been enrolled during Phase 1. Consequently, up to approximately 55 participants will be treated in the study as a whole.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
PLM60 will be administered via intravenous infusion in 28-day cycles for up to 7 cycles.
Gabrail Cancer Center
Canton, Ohio, United States
Gabrial Cancer Center
Canton, Ohio, United States
Percentage of subjects experiencing AEs and SAEs after treatment with PLM60
Percentage of subjects experiencing AEs and SAEs, by evaluating physical examinations, vital signs, ECOG score, ECGs, ECHO or MUGA scans, and clinical laboratory findings
Time frame: 8 Months
Overall response rate in patients with PTCL after treatment PLM60
Assessing the overall response rate (ORR) by Lugano Classification
Time frame: 19 months
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