Loncastuximab Tesirine and Rituximab for Post-transplant Lymphoproliferative Disorder (PLUTO)
This study is testing two drugs, loncastuximab tesirine and rituximab, as a first treatment for people with post-transplant lymphoproliferative disorder (PTLD). PTLD is a type of lymphoma that can happen after an organ transplant. The first part of the study will determine the best dose of these drugs. The second part will see how well the drugs work to shrink or get rid of the cancer. You may be able to join if you are 18 or older, have confirmed B-cell PTLD after a solid organ transplant, and your disease can be measured. The study aims to enroll 23 participants. The current status of the study is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is designed to first find the best dose of the drugs and then to see how effective they are.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure how well the treatment works for up to 4 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07573436
Loncastuximab Tesirine and Rituximab as First-line Therapy in Patients With Post-transplant Lymphoproliferative Disorder (PLUTO)
Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatmentUniversity of UtahInvestigator-initiated
~23 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Loncastuximab tesirineRituximab or rituximab biosimilar
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I: Define Maximum Tolerated Dose (MTD) based on the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period.
Measured over 4 years
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesUtah1
Study leadership
- Narendranath Epperla, MD · PRINCIPAL_INVESTIGATOR · Huntsman Cancer Institute
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Subject aged ≥ 18 years.
Histologically confirmed B-cell PTLD (monomorphic and polymorphic) following solid organ transplantation; with or without EBV association.
Note: Subjects with classic Hodgkin-like PTLD are excluded.
Measurable disease as defined by the 2014 Lugano Classification as assessed by positron-emission tomography (PET)- computed tomography (CT) or by CT or magnetic resonance imaging (MRI) if the tumor is not fluorodeoxyglucose (FDG)-avid on screening
ECOG Performance Status ≤ 2.
Adequate organ function as defined as:
Hematologic:
Absolute neutrophil count (ANC) ≥ 1000/mm3
Platelet count ≥ 75,000/mm3
Hemoglobin ≥ 8 g/dL
Hepatic:
Bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN with document liver involvement and/ or Gilbert's disease
Transaminases (AST or ALT) ≤ 3 x ULN or ≤ 5 x ULN with documented liver involvement
Renal:
Estimated creatinine clearance ≥ 60 mL/min by Cockcroft-Gault formula.
For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
Women \< 50 years of age:
Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
Women ≥ 50 years of age:
Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
Had radiation-induced menopause with last menses \>1 year ago; or
Had chemotherapy-induced menopause with last menses \>1 year ago; or
Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
Female subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception and the lactation requirements as described in Sections 5.4.1 and 5.4.2.
Subjects or their legal representatives must be able to read, understand, and provide informed consent to participate in the trial.
Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol
Exclusion
PTLD following liquid transplantation
CNS involvement
Prior treatment for PTLD with the exception of radiation, antivirals, steroids and reduced immunosuppression
Human immunodeficiency virus (HIV) infection
Major surgery within 4 weeks prior to enrolment
History of bleeding diathesis (e.g., von Willebrand's disease), hemophilia, or active bleeding.
Subjects with chronic liver disease with hepatic impairment Child-Pugh class C
Pregnant or lactating or intending to become pregnant during the study
Active autoimmune disease which, in the opinion of the investigator, may negatively impact subject safety or interfere with study participation.
The diagnosis of another malignancy which, in the opinion of the investigator, is likely to negatively impact subject safety or interfere with study participation.
Significant medical diseases or conditions including those requiring substantial changes in concomitant medications, as assessed by the investigator, that would substantially increase the risk-to-benefit ratio of participating in the study. This includes, but is not limited to the following conditions:
Cardiovascular disorders:
Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.
Myocardial infarction (MI) within 6 months before the first dose.
QTc prolongation defined as a QTcF \> 480 ms.
Congenital long QT syndrome or a corrected QT measure (QTc) interval of \>480 ms at screening (unless secondary to pacemaker or bundle branch block).
Grade 2 or higher edema (peripheral, pleural or ascites)
Grade 1 or higher pericardial effusion
Severe pulmonary disease
Uncontrolled diabetes mellitus
Severely immunocompromised state
Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
Active systemic bacterial, viral, fungal, or other infection requiring systemic treatment at time of screening
Subjects with evidence of active hepatitis B infection, based on positive surface antigen or Hepatitis B DNA PCR are excluded. Subjects who are Hepatitis B core antibody positive must take prophylaxis with entecavir or equivalent and be willing to undergo monthly Hepatitis B DNA PCR testing
Active hepatitis C infection
Grade 2 or higher rash
Clinically significant fluid accumulation in the third space
Subjects taking prohibited medications as described in Section 6.8.1. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.
What this trial measures
- Phase I: Define Maximum Tolerated Dose (MTD) based on the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period.4 years
To assess the Recommended Phase 2 Dose (RP2D) of loncastuximab tesirine and rituximab in participants with post-transplant lymphoproliferative disorders (PTLD).
- Phase II: The complete response (CR) rate after 4 cycles of lonca-R per Lugano 2014 criteria1.4 years
To assess the efficacy of the combination of lonca-R based on CR rate after 4 cycles.