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

NCT06132737 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

  • CNS Lymphoma

Interventions

DRUG

[90Y]Y-PentixaTher

\[90Y\]Y-PTT i.v. injection

Sponsors & Collaborators

  • Pentixapharm AG

    lead INDUSTRY

Principal Investigators

  • Bastian von Tresckow, Prof. Dr. med. · University Hospital, Essen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-07
Primary Completion
2027-09-23
Completion
2028-03-26

Countries

  • Germany

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 NCT06132737 on ClinicalTrials.gov