Actively Recruiting
A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)
Led by ADC Therapeutics S.A. · Updated on 2026-03-13
200
Participants Needed
42
Research Sites
280 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to characterize the safety and tolerability of loncastuximab tesirine in combination with polatuzumab vedotin, glofitamab, or mosunetuzumab, and to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) for the combinations.
CONDITIONS
Official Title
A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosis of relapsed or refractory B-cell Non-Hodgkin Lymphoma as defined by 2016 WHO classification
- Failed or intolerant to approved therapies with at least two prior systemic treatments in Part 1 and at least one in Part 2
- Specific lymphoma types including DLBCL, HGBCL, FL, MZL, MCL, BL depending on study arm
- Life expectancy of at least 24 weeks
- Need for systemic treatment for listed lymphoma indications
- Measurable disease per 2014 Lugano Classification
- Availability of tumor tissue sample
- ECOG performance status of 0 to 2
- Adequate organ function
- Women of childbearing potential must use effective contraception during and after treatment as specified
- Participants aged 80 or older must be fit per CIRS-G scale with limited comorbidity
You will not qualify if you...
- History of hypersensitivity or positive ADA to CD19 antibody causing treatment stop
- Prior treatment with loncastuximab tesirine or study-specific drugs polatuzumab vedotin, glofitamab, or mosunetuzumab
- HIV positive or chronic hepatitis B or C without successful treatment
- History of progressive multifocal leukoencephalopathy
- History of severe skin or immune reactions like Stevens-Johnson syndrome or MAS/HLH
- Significant fluid accumulation requiring drainage
- Pregnant or breastfeeding
- Significant medical illnesses or recent major treatments within 14 days
- Live vaccine within 4 weeks before treatment
- Unresolved severe toxicities from prior therapies
- Active second primary cancer except certain low-risk types
- For Arms E and F: prior stem cell or organ transplant, certain CNS diseases, active infections, autoimmune diseases, recent immunosuppressive treatments, CAR-T therapy within 100 days
- Known hypersensitivity to obinutuzumab for Arm E only
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 42 locations
1
University of California San Francisco - Fresno Center for Medical Education and Research
Clovis, California, United States, 93611
Actively Recruiting
2
Scripps Health - Prebys Cancer Center
San Diego, California, United States, 92103
Actively Recruiting
3
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
4
Miami Cancer Institute
Miami, Florida, United States, 33176
Actively Recruiting
5
Memorial Cancer Institute - Memorial Hospital West
Pembroke Pines, Florida, United States, 33028
Actively Recruiting
6
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
The Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States, 30342
Actively Recruiting
8
Mission Cancer + Blood - Mission Cancer Foundation
Des Moines, Iowa, United States, 50309
Actively Recruiting
9
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
11
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
12
Columbia University Irving Medical Center
New York, New York, United States, 10027
Actively Recruiting
13
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195
Actively Recruiting
14
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
15
Penn Medicine - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
16
Allegheny Health Network - West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
17
Brown University Health - Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
18
Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Completed
19
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Withdrawn
20
Greco-Hainsworth Tennessee Oncology Centers for Research (GHCR)
Nashville, Tennessee, United States, 37203
Actively Recruiting
21
Baylor University Medical Center
Dallas, Texas, United States, 75246
Actively Recruiting
22
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
23
Emily Couric Clinical Cancer Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
24
NEXT Virginia (Virginia Cancer Specialists)
Fairfax, Virginia, United States, 22031
Completed
25
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
26
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
27
Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne
Yvoir, Belgium, B-5530
Actively Recruiting
28
Fakultni Nemocnice Brno
Brno, South Moravian, Czechia, 625 00
Withdrawn
29
Fakultni nemocnice Ostrava
Ostrava, Czechia, 708 52
Actively Recruiting
30
Fakultní Nemocnice Královské Vinohrady
Prague, Czechia, 100 34
Actively Recruiting
31
Fakultni nemocnice v Motole
Prague, Czechia, 150 06
Actively Recruiting
32
Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII
Bergamo, Italy, 24127
Actively Recruiting
33
Centro di Ricerche Cliniche - IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
34
Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia
Brescia, Italy, 25123
Actively Recruiting
35
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
36
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
Barcelona, Spain, 08908
Actively Recruiting
37
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Actively Recruiting
38
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
39
Complejo Asistencial Universitario de Salamanca - Hospital Clínico
Salamanca, Spain, 37007
Actively Recruiting
40
Hospital Universitari i Politècnic La Fe
Valencia, Spain, 46026
Actively Recruiting
41
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PG
Completed
42
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX3 7LE
Completed
Research Team
C
Contact ADC Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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