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Polyspecific Antibodies in Lymphoproliferative T-cell Disorders

NCT06495723 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-07-22

No results posted yet for this study

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

DRUG

LIS1

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

Sponsors & Collaborators

  • Xenothera SAS

    lead INDUSTRY

Principal Investigators

  • Gandhi-Laurent DAMAJ, MD · University Hospital, Caen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-09
Primary Completion
2026-07-31
Completion
2027-07-31

Countries

  • France
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06495723 on ClinicalTrials.gov