NCT04880564

A Study of CN1 in Combination With CN401 in Adult Patients With Relapsed/Refractory Lymphoid Malignancies

An Open-label, Multi-centre, Phase I/II Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of CN1 in Combination With CN401 in Adult Patients With Relapsed/Refractory Lymphoid Malignancies

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Curon Biopharmaceutical (Australia) Co Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to investigate the safety, tolerability and preliminary efficacy in combination with CN1 and CN401 in adult patients with relapsed/refractory lymphoid malignancies.

Detailed description

This is an open-label, multi-center, phase I/II study. The study includes two study drugs CN1 and CN401 and will be conducted in two parts: phase 1 and phase 2. Phase I: Dose-finding study for the assessment of dose limiting toxicities (DLTs) at 3 or more dose levels in patients with advanced lymphoid malignancies. Phase II: Expansion study to evaluate the preliminary efficacy of CN1 in combination with CN401 at the RP2D in parallel patient cohorts grouped by non-Hodgkin's Lymphoma (NHL) subtype. There will 9-18 patients enrolled in the Phase 1 portion of the study and 15- 60 patients will be enrolled in Phase 2 - dosing determined by Phase 1.

Conditions

• Relapsed Lymphoid Malignancies
• Refractory Lymphoid Malignancies

Interventions

Type	Name	Description
DRUG	CN1, 0.5mg/kg and CN401, 400mg	CN1(0.5mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(400mg) will be administered orally twice daily.
DRUG	CN1, 1mg/kg and CN401, 600mg	CN1(1mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(600mg) will be administered orally twice daily.
DRUG	CN1, 1mg/kg and CN401, 800mg	CN1(1mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(800mg) will be administered orally twice daily.
DRUG	CN1, 3mg/kg and CN401, 800mg	CN1(3mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(800mg) will be administered orally twice daily.
DRUG	CN1, 10mg/kg and CN401, 800mg	CN1(10mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(800mg) will be administered orally twice daily.

Timeline

• Start date: 2021-07-28
• Primary completion: 2022-08-29
• Completion: 2022-09-30
• First posted: 2021-05-10
• Last updated: 2022-10-24

Locations

1 site across 1 country: Australia