Actively Recruiting
A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Patients 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and anti-cancer activity of loncastuximab tesirine combined with other drugs—polatuzumab vedotin, glofitamab, or mosunetuzumab—in adults with relapsed or refractory B-cell Non-Hodgkin Lymphoma (B-NHL). This Phase 1b study aims to find the maximum tolerated dose and recommended dose for expansion of these combinations. The study includes different types of B-NHL and is sponsored by ADC Therapeutics S.A. Participants receive treatments in cycles lasting 21 days. Depending on the study arm, loncastuximab tesirine is given intravenously at escalating doses, combined with intravenous polatuzumab vedotin or glofitamab, or subcutaneous mosunetuzumab. Some arms include additional obinutuzumab infusion before treatment. The study has two parts: a dose escalation phase to find safe doses and a dose expansion phase to further evaluate those doses. Participants undergo a screening period of up to 28 days before treatment starts. During treatment, they receive study drugs at scheduled intervals and are monitored for side effects, laboratory changes, vital signs, and performance status. Follow-up visits occur approximately every 12 weeks for up to two to three years depending on the treatment arm. Researchers measure safety outcomes such as adverse events and dose-limiting toxicities, and effectiveness outcomes like response rates and survival over the study period.
CONDITIONS
Brief 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 participant aged 18 years or older
- Pathologic diagnosis of relapsed or refractory B-cell Non-Hodgkin Lymphoma per 2016 WHO classification
- Failure or intolerance to approved therapy with at least two prior systemic treatments in Part 1, and at least one prior systemic treatment in Part 2
- Life expectancy of at least 24 weeks
- Need systemic treatment as assessed by the investigator
- Measurable disease by 2014 Lugano Classification
- Availability of tumor tissue block
- ECOG performance status 0 to 2
- Adequate organ function
- Women of childbearing potential must use effective contraception until 10 months after last dose; men with female partners must use condoms or abstain until 7 months after last dose
- Participants 80 years or older must be deemed fit by CIRS-G scale with no severe scores
You will not qualify if you...
- Known hypersensitivity or positive antibodies to CD19 antibody leading to treatment discontinuation
- Prior therapy with loncastuximab tesirine
- Prior treatment with polatuzumab vedotin, glofitamab, or mosunetuzumab for the relevant study arm
- HIV positive status
- Chronic hepatitis B or hepatitis C infection without curative treatment
- History of progressive multifocal leukoencephalopathy
- History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or macrophage activation syndrome
- Significant fluid accumulation requiring drainage or causing breathing difficulty
- Pregnancy or breastfeeding
- Significant medical comorbidities
- Recent major surgery, radiotherapy, chemotherapy, or anti-cancer therapy within 14 days unless approved
- Live vaccine within 4 weeks prior to study drug start
- Failure to recover from prior acute non-hematologic toxicity except alopecia
- Active second primary malignancy except certain skin, prostate, cervical, or breast conditions
- Additional exclusions for Arms E and F including prior stem cell transplant, CNS lymphoma or disease, active infections, autoimmune diseases, recent immunosuppressive treatments, and known hypersensitivity to obinutuzumab (Arm E only)
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 - Up to 1 year or until disease progression or unacceptable toxicity
Participants receive treatment cycles consisting of loncastuximab tesirine in combination with other anti-cancer agents. Each cycle lasts 21 days, and treatment may continue for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria.
Repeated 21-day cycles with specific dosing on cycle days depending on the treatment arm
Duration - Up to approximately 2 years for Arm C and 3 years for Arms E and F
Participants are monitored after treatment ends with visits approximately every 12 weeks to assess safety and anti-cancer activity.
Visits approximately every 12 weeks
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
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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