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RECRUITING
NCT06495723
PHASE1/PHASE2

Polyspecific Antibodies in Lymphoproliferative T-cell Disorders

Sponsor: Xenothera SAS

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2024-07-09

Completion Date

2027-07-31

Last Updated

2025-07-22

Healthy Volunteers

No

Interventions

DRUG

LIS1

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

Locations (8)

CHU de Caen

Caen, France

CHU de Clermont-Ferrand

Clermont-Ferrand, France

CHU Henri-Mondor

Créteil, France

CHU de Bordeaux - GH Sud - Hôpital Haut-Lévêque

Pessac, France

CHU de Lyon - Hôpital Lyon Sud

Pierre-Bénite, France

SC Ematologia Istituto Nazionale dei TumoriIRCCS Fondazione "G. Pascale"

Naples, Campania, Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola

Bologna, Emilia-Romagna, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, Italy