Polyspecific Antibodies in Lymphoproliferative T-cell Disorders
ConditionPeripheral T Cells Lymphoma (PTCL)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorXenothera SAS
About this trial
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 criteria
Qualifiers
Provide signed, written informed consent.
Is male or female, age ≥18 years old (at the time consent is obtained)
For Part 1: Has a histological diagnosis of the following relapsed or refractory PTCL based on WHO 2022 classification of lymphoid neoplasms
Intestinal T-cell and NK cell lymphoid proliferations and lymphomas (without NK cell neoplasms)
Disqualifiers
Is diagnosed with a bulky disease (≥10 cm).
Has known history or presence of central nervous system involvement by leukemia or lymphoma.
Has Mature T-cell and NK-cell leukemias (WHO 2022 criteria)
Has T-lymphoblastic leukemia/lymphoma (WHO 2022 criteria)
Trial design
Treatments tested in this trial
- LIS1
Treatment groups
54 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov