NCT03553914

PLM60 for Peripheral T Cell Lymphoma (PTCL)

A Randomized Phase 1-2 Study of PLM60 in Patients With Peripheral T-Cell Lymphoma

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Conjupro Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Peripheral T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	PLM60	PLM60 will be administered via intravenous infusion in 28-day cycles for up to 7 cycles.

Timeline

• Start date: 2021-01-01
• Primary completion: 2024-01-01
• Completion: 2025-01-01
• First posted: 2018-06-12
• Last updated: 2020-10-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study