Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04970901

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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