Actively Recruiting
An Open-label Dose Escalation Study to Evaluate Safety, Tolerability, Biodistribution and Efficacy of [90Y]Y-PentixaTher for Recurrent or Refractory CNS Lymphoma
Led by Pentixapharm AG · Updated on 2026-06-05
15
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of [90Y]Y-PentixaTher ([90Y]Y-PTT) to treat patients with recurrent or refractory primary or isolated secondary central nervous system (CNS) lymphoma. This open-label, single-arm phase 1/2 study aims to evaluate the safety, tolerability, biodistribution, and preliminary effectiveness of this treatment. The study includes three dose-level groups, and a safety review committee will carefully monitor for any dose-limiting side effects to guide dose adjustments. Participants will receive one cycle of [90Y]Y-PTT administered intravenously. The study follows a best-of-5 dose escalation design across three cohorts with different dose levels. There is no comparison group in this study. After the treatment, patients will undergo several visits during the core study phase to assess safety, how the drug spreads in the body, dosimetry, and treatment response. Following this, three follow-up visits will occur at three-month intervals to monitor disease status. Throughout the study, participants will be closely monitored for adverse events, with severity graded by standard criteria. Various imaging and laboratory tests will be performed shortly after infusion and at multiple time points to measure drug uptake in tumors and organs, blood levels, and absorbed radiation doses. Researchers will assess response rates, progression-free survival, and overall survival at one, three, six, nine, and twelve months after treatment. The total study duration includes screening, treatment, core evaluations, and extended follow-up visits to comprehensively evaluate treatment outcomes and safety.
CONDITIONS
Brief Title
[90Y]Y-PTT Endoradiotherapy in CNS Lymphoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study activities
- Patients of any gender aged over 18 years
- Body weight less than 180 kg
- At least one measurable lymphoma lesion in the central nervous system
- Confirmed relapsed or refractory primary or isolated secondary CNS lymphoma without peripheral lymphoma
- Recurrent or refractory CNS lymphoma as defined by disease status
- Stored stem cells with at least 2 x 10^6 CD34+ cells/kg body weight
- For sexually active females of childbearing potential: agreement to use contraception during and six months after study
- Female patients without childbearing potential documented by history or post-menopausal status
- Male patients with partners of childbearing potential agree to use contraception during and six months after treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- CXCR4-positive tumor lesions confirmed by PET scan within two months before enrollment
- Blood counts and organ function within specified limits including neutrophils, hemoglobin, platelets, liver enzymes, creatinine, GFR, and bilirubin
You will not qualify if you...
- Known or suspected allergy to the study drug or related products
- Contraindications to contrast-enhanced MRI such as pacemaker, metal implants, renal insufficiency, or severe claustrophobia
- Previous participation in this study
- Pregnancy, breastfeeding, or inadequate contraception in females of childbearing potential
- Inadequate contraception in males of reproductive age
- Participation in another investigational drug study within the last 30 days
- Any serious disorder or lab abnormality that may risk patient safety or study compliance
- Active infection or serious infection within six weeks prior to treatment
- Uncontrolled HIV infection or active hepatitis B or C infection
- Secondary CNS lymphoma with systemic involvement
- Chronic use of immunosuppressive drugs over 21 days
- Mental incapacity or uncooperative behavior without a legal representative
- Brain radiation therapy within 180 days before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single cycle
Participants receive one cycle of [90Y]Y-PentixaTher administered intravenously in a dose escalation design across three cohorts.
1 infusion visit
Duration - Up to 12 months
Participants are monitored for safety, efficacy, and biodistribution through imaging and clinical assessments up to 12 months post infusion.
Multiple visits including assessments at 1 month, 3 months, 6 months, 9 months, and 12 months post infusion
Trial Site Locations
Total: 2 locations
1
University Hospital Rechts der Isar
Munich, Bavaria, Germany, 81675
Withdrawn
2
University Hospital Essen
Essen, Germany
Actively Recruiting
Research Team
S
Simone Pickel
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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