[90Y]Y-PTT Endoradiotherapy in CNS Lymphoma Patients

CNS Lymphoma Clinical Trial

Official title: An Open-label Dose Escalation Study to Evaluate Safety, Tolerability, Biodistribution and Efficacy of [90Y]Y-PentixaTher for the Therapy of Recurrent or Refractory Primary or Isolated Secondary Central Nervous System Lymphoma.

Status Recruiting

Clinical Trial Summary

This will be an open-label, single-arm, national phase 1/2 therapeutic study to evaluate the safety, tolerability, and preliminary efficacy of [90Y]Y-PentixaTher ([90Y]Y-PTT) for the treatment of recurrent or refractory primary or isolated secondary central nervous system (CNS) lymphoma. The study will be performed in three cohorts with different dose levels according to the best-of-5 dose escalation design. A safety review committee (SRC) will evaluate dose-limiting toxicities and decide about escalation and de-escalation. Eligible patients will receive one cycle of [90Y]Y-PTT, which will be administered intravenously. There will be no comparator in this study. Safety, biodistribution, dosimetry and efficacy will be evaluated during the core study phase (Visit 1 until Visit 5). Thereafter three follow-up (FU) visits will take place, at three-months intervals to evaluate the extent of disease.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• CNS Lymphoma
• Lymphoma

• NCT number: NCT06132737
• Study type: Interventional
• Source: Pentixapharm AG
• Contact: Simone Pickel
• Phone: +49-172-426-9635
• Email: PTT101@pentixapharm.com
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 7, 2023
• Completion date: April 26, 2026