NCT06495723

Polyspecific Antibodies in Lymphoproliferative T-cell Disorders

Phase I/II, Open-label, Multi-center Study to Evaluate the Safety and Efficacy of Glyco-humanized Polyclonal Antibody Directed Against Tumoral T Cells, in Patients With Relapsed/Refractory Peripheral T Cells Lymphoma (PTCL)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Xenothera SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 2-part study consisting of a Part 1, dose escalation and dose-finding component to establish the Maximal Tolerated Dose (MTD), or Recommended Part 2 Dose (RP2D) of LIS1 as a single agent; followed by a Part 2, to investigate anti-tumors efficacy of LIS1 in selected subtypes of Peripheral TCell Lymphoma (PTCL) and to further evaluate its safety and tolerability at RP2D.

Conditions

• Peripheral T Cells Lymphoma (PTCL)

Interventions

Type	Name	Description
DRUG	LIS1	The study intervention (LIS1) is a glyco-humanized polyclonal antibody drug which is formulated for IV administration.

Timeline

• Start date: 2024-07-09
• Primary completion: 2026-07-31
• Completion: 2027-07-31
• First posted: 2024-07-11
• Last updated: 2025-07-22

Locations

8 sites across 2 countries: France, Italy