RecruitingPhase 1Phase 2NCT06495723

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)


Sponsor

Xenothera SAS

Enrollment

54 participants

Start Date

Jul 9, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new type of immune therapy (polyspecific antibodies) that targets multiple proteins at once in people with rare and aggressive T-cell lymphomas (cancers of the immune system's T-cells) that have come back or stopped responding to treatment. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of a relapsed or refractory T-cell lymphoma (such as hepatosplenic T-cell lymphoma, anaplastic large cell lymphoma, or nodal TFH lymphoma, among others, per WHO 2022 classification) - Your cancer has returned after prior treatments **You may NOT be eligible if...** - You have active brain involvement of your lymphoma - You have severe organ dysfunction or serious active infections - You are pregnant or breastfeeding - You have recently received other investigational therapies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLIS1

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06495723


Related Trials