RecruitingPhase 1Phase 2NCT06132737

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

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.

Sponsor

Pentixapharm AG

Enrollment

15 participants

Start Date

Nov 7, 2023

Study Type

INTERVENTIONAL

Conditions

CNS Lymphoma

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.

Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a targeted radioactive therapy called [90Y]Y-PTT that is designed to deliver radiation directly to lymphoma cells in the brain and central nervous system (CNS). It is for patients with CNS lymphoma (a type of lymphoma that affects the brain or spinal cord lining) that has come back or stopped responding to prior treatments. **You may be eligible if...** - You are 18 or older with relapsed or refractory CNS lymphoma (either primary or secondary) - You have at least one measurable lymphoma lesion in the brain - A special PET scan has confirmed that your tumors express the CXCR4 receptor (needed for the drug to work) - You have stored stem cells available - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have a pacemaker, metal implant, or severe kidney disease that prevents MRI scans - You are pregnant or breastfeeding - You have been in another clinical trial within the past 30 days - You have a history of serious infection in the past 6 weeks - You have had brain radiation within the past 6 months 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.

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