A Phase 1/2 interventional study of PLM60 in Peripheral T Cell Lymphoma, sponsored by Conjupro Biotherapeutics, Inc.. Withdrawn at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-19.
Sponsored by Conjupro Biotherapeutics, Inc. · Phase 1/2, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
Browse Lymphoma studies →Conjupro Biotherapeutics, Inc. is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Additional Inclusion Criteria for Phase 2:
Key Exclusion Criteria:
Subjects will receive PLM60 at 12 mg/m\^2 dose.
Drug: PLM60
Subjects will receive PLM60 at 16 mg/m\^2 dose.
Drug: PLM60
Subjects will receive PLM60 at 20 mg/m\^2 dose.
Drug: PLM60
PLM60 will be administered via intravenous infusion in 28-day cycles for up to 7 cycles.
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
This study is withdrawn, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Conjupro Biotherapeutics, Inc.