Loncastuximab Tesirine and Rituximab as First-line Therapy in Patients With Post-transplant Lymphoproliferative Disorder (PLUTO)
NCT07573436 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2026-05-07
Summary
The purpose of phase I of this clinical trial is to learn the recommended dose of the drugs loncastuximab tesirine and rituximab in participants with post-transplant lymphoproliferative disorders (PTLD).
The purpose of phase II of this clinical trial is to learn if the drugs loncastuximab tesirine and rituximab are effective in participants with post-transplant lymphoproliferative disorders (PTLD).
Conditions
- Post-transplant Lymphoproliferative Disorder
Interventions
- DRUG
-
Loncastuximab tesirine
Lonca will be administered by IV at 75µg/kg every 3 weeks (DL1).
- DRUG
-
Rituximab or rituximab biosimilar
Rituximab or rituximab biosimilar will be administered by IV at 375 mg/m2 on Day 1 of every cycle. Lonca will be administered first, followed by rituximab (with a 30 min wait time between the two agents)
Sponsors & Collaborators
-
ADC Therapeutics S.A.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Narendranath Epperla, MD · Huntsman Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2030-06-30
- Completion
- 2031-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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