Actively Recruiting
[90Y]Y-PTT Endoradiotherapy in CNS Lymphoma Patients
Led by Pentixapharm AG · Updated on 2026-05-12
15
Participants Needed
2
Research Sites
228 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
[90Y]Y-PTT Endoradiotherapy in CNS Lymphoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before study activities
- Age greater than 18 years
- Body weight under 180 kg
- At least one measurable lymphoma lesion in the central nervous system
- Histologically, cytologically, or radiologically confirmed relapsed or refractory primary or secondary CNS lymphoma
- Stored stem cells with at least 635 10^6 CD34+ cells/kg body weight
- Women of childbearing potential agree to contraceptive measures during and 6 months post-study
- Female patients without childbearing potential by documented history or post-menopausal status
- Male patients with partners of childbearing potential agree to effective contraception during and 6 months post-treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Confirmed CXCR4 positive tumor lesions by PET scan within 2 months prior to enrollment
- Adequate blood counts and organ function as specified (neutrophils above 1.0 x 10^9/L, hemoglobin 8 g/dL or higher, platelets 75 x 10^9/L or higher, liver enzymes and bilirubin within 3 times upper normal limit, creatinine and GFR within defined limits)
You will not qualify if you...
- Known or suspected allergy to the study drug or related products
- Contraindications to contrast-enhanced MRI or gadolinium use (e.g., pacemaker, metal implants, renal issues, severe claustrophobia)
- Previous participation in this study
- Pregnant or breastfeeding women, or women of childbearing potential not using adequate contraception
- Male patients not using adequate contraception if partner is of childbearing potential
- Participation in another investigational drug study within 30 days prior to screening
- Any active or uncontrolled medical condition that could risk safety or study compliance
- Active infection or recent serious infection within 6 weeks prior to treatment
- Uncontrolled HIV infection or active hepatitis B or C infections
- Secondary CNS lymphoma with systemic involvement
- Chronic use of immunosuppressive drugs longer than 21 days
- Mental conditions impairing understanding or cooperation
- Brain radiation therapy within 180 days prior to study treatment
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University Hospital Rechts der Isar
Munich, Bavaria, Germany, 81675
Actively Recruiting
2
University Hospital Essen
Essen, Germany
Actively Recruiting
Research Team
S
Simone Pickel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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